Category Archives: Testosterone

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Ehormones MD: HGH Therapy | Testosterone Replacement Therapy

Testosterone plays a vital role in a range of bodily functions, including muscle and bone health, cognition, red blood cell and sperm formation, and sexual and reproductive function in males.

Testosterone levels can decline for various reasons, including stress, aging, trauma, and infections.

This article discusses TRT in more detail, including who it is for, the types, how it works, how to get it, what to expect from it, and more.

TRT or androgen replacement therapy (ART) is a treatment that doctors give to males who have testosterone deficiency and are showing symptoms of hypogonadism.

Taking prescription testosterone helps restore the levels of this hormone in the blood, reversing the symptoms of low testosterone. People who take it may notice improvements in alertness, sexual function, energy, mood, and overall well-being.

Doctors prescribe TRT to males with hypogonadism. To receive a definitive diagnosis, blood tests must show that a person has low testosterone levels, which the American Urological Association notes as being below 300 nanograms per deciliter (ng/dl). The individual must also have other symptoms, such as fatigue, breast growth, and sexual dysfunction.

However, doctors do not usually recommend TRT as the first course of action for low testosterone levels, even for males who show such symptoms.

If other conditions or medications cause testosterone levels to drop, doctors usually treat the underlying condition before recommending TRT.

According to a 2019 study, TRT can improve sexual function, including:

Further 2019 research suggests that TRT can also maintain bone density, with a 2016 study also revealing TRTs improvement of cognitive function and attention span.

TRT is only available with a prescription. If a person presents with symptoms consistent with low testosterone levels, a doctor will only provide a prescription after taking a thorough medical history and performing physical and lab exams.

As hormone levels fluctuate depending on activity levels, diet, and the time of day, doctors usually take two different blood samples before noon. They may sometimes also ask for imaging studies and additional tests, such as tests for luteinizing hormone and follicle stimulation hormone, to determine the cause of the low testosterone levels.

There are several ways to administer testosterone:

Injectable testosterone is an inexpensive and common form of TRT. A person can receive short-acting treatment, which involves a shot every 1 or 2 weeks, or long-acting treatment, in which the second shot is 4 weeks after the first, and all others are 10 weeks apart. The dosage and frequency of the treatment may vary depending on the person.

Doctors inject short-acting testosterone under the skin or into the muscle, while long-acting shots go in the gluteal muscles.

TRT can cause fluctuations in testosterone levels, which can affect energy levels, libido, mood, and the presence of symptoms such as breast tenderness.

People usually apply gels and creams on a daily basis. Gradual absorption causes more stable testosterone levels in the blood.

However, people using topical treatments must be careful to avoid skin-on-skin contact with other people for at least 6 hours after application. It is important to prevent the risk of transferring the medication onto other peoples skin because it may be dangerous for pregnant people and children.

Topical patches stick to the skin and stay in place for 24 hours until the next dose. They typically come in doses of between 2 milligrams (mg) and 5 mg. The downsides to patches are that they are not cosmetically appealing and often cause skin irritations. In comparison with oral medications, topical patches may prove less toxic to the liver.

Topical gel dosage is usually between 40100 mg per day but this will vary between products. A person should start at the lowest recommended dose and increase gradually, if necessary.

A person places a buccal patch above the upper teeth, and it releases testosterone over 12 hours. These patches usually contain 30 mg. A person should apply them twice each day, around 12 hours apart. However, they can cause headaches and gum and mouth irritation.

Testosterone pellets are small plastic pellets that doctors implant under the skin. The implant goes into a persons upper hip or buttock. The pellets dissolve slowly and can deliver TRT for 36 months. The dosage varies between individuals and a person should discuss this with their doctor prior to the first implantation.

Inserting implants is a minor inpatient surgical procedure. A doctor makes a small incision in the fatty tissue below the skin to insert the pellets. They perform the procedure under local anesthesia.

Learn more about testosterone pellets here.

Oral testosterone is a less common type of TRT that is more expensive and less practical. Its long-term use can potentially cause liver damage.

Most tablets also come with warnings about the drug causing hypertension and stroke. As a result, only individuals who cannot use other forms of TRT resort to taking testosterone by mouth.

A doctor will recommend a Dosage ranging from 225396 mg, and a person will typically take oral testosterone tablets twice daily.

A person applies nasal testosterone gel to the inside of the nose. They will need to do this three times a day at intervals of 68 hours, preferably at the same times every day. Dosage is usually 11 mg per application across both nostrils, resulting in a total dosage of 33 mg daily.

Some common reactions to this treatment include headaches, nosebleeds, a runny nose, and nasal discomfort.

TRT aims to restore a persons testosterone levels to normal. The individual can expect improvements in their blood testosterone levels within a week, however, symptoms may take longer to improve.

A person may also note other benefits, such as an increase in bone density and lean body mass, an improvement in well-being, and a boost to energy and libido. It may take from 4 weeks to several months to see positive changes.

Unless caused by medical illness, TRT is typically a lifelong treatment. Once a person starts TRT, their doctor will continually monitor their response to treatment. People need to have routine checkups at least every 612 months to assess their blood testosterone levels.

A doctor will also monitor changes in symptoms and side effects at 3 and 6 months after the initial treatment and then annually.

TRT costs range from $150 to $1,500 per month and vary depending on various factors, including:

In addition to the possible short-term side effects, TRT may also cause health risks. The Endocrine Society recommends that people with the following conditions do not start using TRT:

It also states that the treatment is unsuitable for males who wish to conceive in the near future.

Males aged 40 years older, preadolescent people, and those with migraine or epilepsy may require special considerations.

The Food and Drug Administration (FDA) explains that the benefits and safety of TRT for treating low testosterone levels due to aging are not known. The organization requires that testosterone products carry warnings mentioning the possible risk of stroke and heart disease.

A 2017 review found that males undergoing TRT may have a higher risk for cardiovascular events such as stroke. However, further research will help to confirm this.

Other side effects of taking testosterone include:

High cholesterol may also be a side effect. However, a 2021 study suggests that TRT may improve total cholesterol levels.

The current scientific literature suggests that TRT worsens breast and prostate cancer. However, TRT may offer benefits to people with early stage prostate cancer without stimulating the recurrence or progression of cancer.

A person can try to improve their testosterone levels without medical intervention. Some ways may include:

If any individual takes medications they believe lowers testosterone, they should consider discussing this with their doctor.

Find out more about natural ways to boost testosterone here.

The following are common questions about TRT.

TRT costs range from $1501,500 per month, depending on the type of TRT, the mode and frequency of administration, and a persons insurance coverage.

Yes. Most insurance companies cover all forms of TRT. However, there may be out-of-pocket costs. Individuals should always confirm coverage with their insurer to avoid any unwanted expenses.

Although TRT offers benefits to people with low testosterone levels, it can cause many short-term side effects. In the long term, it may also increase the risk of liver and heart conditions.

TRT treatment length is indefinite unless the low levels are due to an underlying cause that is treatable.

Some physical changes that TRT can bring about include increased muscle mass and bone density, and decreased body weight.

If a person has TRT as a treatment for a health condition, their medical insurance should cover this cost.

TRT is a common treatment for low testosterone levels, but it may not suit everyone.

People who are considering TRT need a prescription and appropriate guidance from a doctor or qualified healthcare professional.

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Testosterone replacement therapy (TRT): What to know - Medical News Today

Hormones are chemical messages sent around the body that stimulate physiological change, bringing improved states of function and balance. Insulin, for example, is released after a meal and tells receptor cells around the body to absorb glucose in readiness for future energy demands. Unfortunately, our hormonal efficacy tends to deteriorate as we age.

Insulin is just one of many hormones that comprise our endocrine system, which is responsible for the hormones that control metabolism, growth, organs, mood and reproduction but we also have dominant sex hormones that drive our development, function and daily lived experience.

Testosterone is a key sex steroid for males (although it also circulates in females at lower levels) used to calibrate functions including libido, muscle mass, bone density and fat storage.

As you may have guessed, testosterone declines slowly past the age of 30 such that a normal level for under-50 males is 8.7-29nmol/L (female 0.2-1.7nmol/L), while the over-50 male range drops to 6-26nmol/L.

This is a very gradual drop that can, to a point, be offset with strength training, nutrition, and lifestyle adaptations, says endocrinologist Dr Nicky Keay. The hormone drop in males is linear, while for many females, especially masters athletes, the opposite is true.

Photo: Thomas Barwick via Getty

The principal female hormones are oestrogen and progesterone. The former has positive ramifications for heart and bone health as well as brain function and general mood. The latters primary role is to balance oestrogen levels to ensure the ongoing health of the uterus.

The menopause is the point in time when female ovaries stop producing hormones and eggs. But this is not an on/off switch. Perimenopause is the transition to retirement of the ovaries, says Dr Keay. Sometimes you feel OK and sometimes you dont.

Symptoms of perimenopause include hot flushes, poor sleep, fatigue, feeling happy or sad for no reason, muscle and joint aches. For masters athletes the list of symptoms adds even more stress, precisely because female hormones are so critical for the maintenanceof consistent intense training and performance.

Until relatively recently, women had to accept it, but hormone replacement therapy, HRT, has changed that. As Dr Keay says, Why should females feel like this for the rest of their lives? We could potentially spend between one third to a half of our lives feeling like this.

Photo: Tom Roberton via Getty

HRT is a prescribed combination of progesterone and oestrogen. Dr Keay cites several key issues to consider for athletes contemplating HRT.

First off, its better to start HRT early to get the best long-term effects. The most effective HRT chemicals have the same molecular structure as your body produces and should be taken through the skin as a gel or patch, and thedose will require personalising.

So what will a female athlete feel when they start on HRT? Dr Keay predicts they should feel better recovery, focus and drive, but also cautions that female masters athletes, even on HRT, should plan to be kinder to themselves, as well as scheduling more time for recovery and strength training to offset both bone-minerality and muscle-bulk loss.

Jenny Copnall, five-time national mountain-bike champion turned cycling coach, says, As a coach Id approach menopause in much the same way as I do working with any rider, and that is through good communication, great attention to recovery and recovery indicators, and working with the individual to tailor a plan to suit their needs and lifestyle. Just like menstrual cycles, its a pretty individual thing.

Photo: Justin Paget via Getty

The controversy over HRT has now largely been dispelled by recent research, so what about testosterone replacement therapy (TRT) as males advance in age and lose hair, muscle mass and vitality? TRT and HRT are not actually compatible propositions, because testosterone and oestrogen decline at very different rates.

Females lose 90% of their hormones over a very short time-span. Post-30 males, on the other hand, have a constant and shallow decline in testosterone production, around 1-2% per year.

TRT carries health risks such as liver damage, cardiac problems and increased incidence of prostate cancer, while health and performance advantages are at best questionable.

Instead, male masters athletes can modify their lifestyle, training and diet. For many female masters athletes, however, HRT is potentially an incredibly effective tool to keep performing at a high level.

Photo: Danny Bird

Phil Cavell is co-founder and bikefitter atCyclefitin London. His bookThe Midlife Cyclistis available on Amazon (12.59)

This article is for informational purposes only and does not constitute medical advice. If you're interested in HRT or other therapies, consult your doctor.

Looking for more women's cycling? Head to our dedicated women's cycling hub.

Main image: SolStock via Getty

Read more:
Cycling and HRT: How will it affect me? - Cyclist

Supporters stand in front of a pile of fire burned wreckage at Knoxville's Planned Parenthood on Jan. 6. Brianna Paciorka/News Sentinel/USA Today Network via Reuters hide caption

Supporters stand in front of a pile of fire burned wreckage at Knoxville's Planned Parenthood on Jan. 6.

When someone set ablaze the only Planned Parenthood health clinic in Knoxville, Tenn., earlier this year, the center was immediately inundated with patients' questions of what will happen to their care but it wasn't just about abortion services.

"We were flooded with calls more from our gender-affirming hormone patients than from any other type of patient because we are a continuing source of care for gender-affirming patients," Ashley Coffield, the chief executive officer of the Planned Parenthood of Tennessee and North Mississippi, told NPR.

"It was very upsetting and scary to them when we were suddenly gone."

When reproductive health clinics close, it's not just access to abortions that are lost, but also an array of services like birth control, sex education and gender-affirming treatments that can disappear.

And some of those services, like hormone replacement therapy, require patients to see their physician more regularly than typical patients visiting for abortion or birth control services, Coffield explains.

That's why she and other providers are particularly worried about how future clinic closures may impact transgender and nonbinary patients, who already face many barriers to health care. The threat of losing access also comes as some states ramp up legal efforts to restrict such care, particularly for transgender youth.

Gender-affirming care includes medical, social and psychological support to help a person understand and appreciate their gender identity. That care could be helpful to anyone but is especially life-saving for transgender and nonbinary people.

Dr. Bhavik Kumar, the medical director of primary and trans care at Planned Parenthood Gulf Coast, told NPR the community faces a crisis.

"With trans care, this is not a drill," he said. "As much as people are concerned about abortion care and access to abortion which is very important we should also be concerned about trans people and preserving their humanity and dignity."

Before the fire, more than 700 of the Knoxville clinic's 4,000 patients sought hormone replacement therapy in 2021, according to Coffield.

That makes sense, she added, because clinics that perform abortions are often well-positioned to provide gender-affirming care.

"Both gender-affirming hormone care and abortions are essential health care that aren't offered by most providers, and both are stigmatized services," she said. "So the same values we use in abortion care like self-determination, respect and a nonjudgmental approach to health care translate really easily into serving our gender-affirming hormone care patients."

Kumar said that's why more than half of all Planned Parenthood health centers offer gender-affirming care including hormone replacement therapy, mental health services and support with legal processes like name changes.

Over 35,000 of Planned Parenthood's patients nationwide sought gender-affirming hormone replacement therapy in 2021, and that number doesn't include trans and nonbinary people who relied on other services, according to Kumar.

When Jake Gutridge received word that his Planned Parenthood health clinic burned down, his immediate thought was, "Oh God, what am I gonna do?"

Gutridge told NPR he had been relying on the clinic to receive hormone replacement therapy for nearly two years. At the time, Planned Parenthood was the only provider he knew of that was nearby and didn't require insurance.

For weeks, he tried to refill his medication with the Planned Parenthood centers in North Carolina and Georgia, both of which are over four hours away. But appointments were booked up to a month, he said. Gutridge quickly fell into withdrawal, suffering from mood swings and anxiety.

Eventually, he was connected to a gender-affirming physician in east Tennessee but Gutridge largely chalked it up to luck. Eight months later, people seeking hormone replacement therapy are still reeling from the fire and reaching out to Gutridge for help.

Since the reversal of Roe, Gutridge said he wouldn't be surprised if other communities experience a similar fallout.

"There's a lot of people who think gender-affirming care is more of a privilege, but it's necessary health care," Gutridge said. "I used to feel trapped in my body, like I was constantly fighting against myself. When I started testosterone, I finally felt like I was in control. It saved my life."

After the fire, the Planned Parenthood affiliate continued to offer services through telehealth. But even then, Coffield said only a fraction of their transgender and nonbinary patients could be served because of capacity constraints.

That's when local physicians began to see a surge of inquiries about gender-affirming care.

"We had an extremely huge influx of folks that had been displaced," Dr. Annie Kolarik told NPR. She is a primary care doctor whose office is located a few miles from the former Planned Parenthood location.

At Cherokee Health Systems, Kolarik estimated that she now serves over 150 patients who had relied on gender-affirming care from Planned Parenthood many of whom travel at least an hour to receive services. Before the fire, she had about 30 patients seeking that kind of care.

To meet the demand, Kolarik said Cherokee Health Systems set up an online appointment system to expedite scheduling and began using telehealth services. Doctors and other practitioners are meeting with patients on their lunch of administrative breaks.

"People should expect similar surges if places where Planned Parenthoods or abortion clinics that offer gender-affirming care end up closing," she said.

Choice Health Network, a provider in the area that exclusively serves HIV-positive patients and those at risk of contracting the virus, has also seen a higher call volume about gender-affirming treatments. It's considering expanding such services, a nurse practitioner at Choice Health Network told NPR.

"The fire seemed designed to send a message to all of us who support Planned Parenthood or who use its services that we are not safe," Meg Gill said. "We need to continue to offer those services and, as much as possible, to expand them."

In areas where gender-affirming care is few and far between, clinics like Planned Parenthood are often the only place where transgender and nonbinary people access any kind of health care, said Kumar, who is in the Gulf Coast.

"When that's taken away, they're left sometimes with no options," he added.

So far, no Planned Parenthood clinics have closed since the Supreme Court's decision in June to overturn Roe v. Wade. Even in states imposing abortion bans, a spokesperson for Planned Parenthood's national organization told NPR their clinics are determined to stay open to continue offering services like gender-affirming care.

In that vein, the Planned Parenthood health clinic in Knoxville, Tenn., is planning to rebuild its office as well as launch a mobile health unit in the fall to keep providing support. That's despite the state planning to ban all abortion at the end of August.

"Everyone who knows us in Knoxville isn't surprised that we're reopening whether abortion is banned or not because they count on us for so many other services," Coffield said.

Independent providers, who tend to more financially rely on abortion services, are also fighting to keep their doors open.

In West Virginia, the Women's Health Center recently expanded its services to provide hormone replacement therapy even as it might lose nearly half of its revenue if lawmakers enact an abortion ban, the clinic's executive director told NPR.

"We believe in patient-centered health care that honors autonomy and dignity of our clients. Expanding our service array to include gender-affirming hormone therapy is completely in line with that vision," Katie Quinonez said.

"No matter what happens to legal abortion in our state, we will continue doing everything in our power to expand and meet the health care needs in our community."

Continued here:
How gender-affirming care may be impacted when clinics that offer abortions close - NPR

A woman who said she went through hell with the menopause and had to be admitted to hospital six times is sharing her story in the hope of helping others.

Annie Cardone, from Rainham, suffered from insomnia and sleep psychosis before doctors diagnosed her as menopausal. But hormone replacement therapy made her aggressive and agitated.

Annie officially went into menopause age 50, but unknowingly went into perimenopause the time leading up to the menopause a few years prior.

She said: "I didn't know and a lot of women don't know anything about perimenopause.

"I was 48 years old, I still had my cycle and that's what throws a lot of women off, they don't realise that it's coming.

"You start to feel a little more emotional, I mean for me the dominant symptom was insomnia.

"I could not sleep and I didn't know what was wrong with me.

"I went to my doctor and I got no help there. It was 'well we can refer you to a psychiatrist', and I don't really believe in psychiatric drugs."

She said that psychiatric help was "never a solution" for her.

Annie's father passed away in 2013 and her insomnia persisted. After three or four nights without sleep she went into sleep psychosis which causes hallucinations and delusional thinking.

"My mother had to get an ambulance and get me to a hospital where I was sedated," Annie said.

"A few days later I was completely back to normal and it was like 'wow what just happened?'."

Annie says none of the doctors she saw mentioned it could have been menopause, so she had not even considered it.

"I put it down as maybe I had a bit of a breakdown, my dad had died and it was understandable, but then it happened again when I moved to America."

When she was in the USA, she was lucky enough to find a doctor who specialised in hormones and told her it was likely she was in menopause.

Annie said she opted for hormone replacement therapy (HRT) but this made things "much much worse".

HRT is a treatment which aims to relieve symptoms of the menopause, and it replaces hormones which are at a lower level.

Annie said: "The HRT was an absolute rollercoaster. I was frequently changed from pills, to patches to creams.

"It was three years of HRT trial and error hell, and I was probably hospitalised five times.

"I was put on a testosterone implant at first at the cost of 1,500, and it made me aggressive and agitated. I had to put up with that for three months."

Annie has now written about her experiences in a book and is holding a series of events across Kent, giving women the opportunity to talk about what they are going through and to get support.

In recent years, well-known names such as Lorraine Kelly and Carol Vorderman have been raising awareness of the menopause, while presenter Davina McCall, who created the Channel 4 documentary Sex, Myths and the Menopause, has been calling for better support for women.

But Annie said the sort of help celebrities can get is out of reach for many.

She explained: "I think a lot of times women in the public eye are talking about menopause but they've had so much help and assistance.

"They've had all the help that money can buy and for a lot of these women they don't have the money to throw at that sort of thing.

"Especially with the cost of living going up, I really wanted to reach out to the community and offer my advice and information I've gathered and share a bit about what I went through."

Annie is putting on the talks to help women to understand what the stress of menopause is doing to their bodies, and to educate them on how to make positive changes.

She said: "I went on this horrific journey and I came to the conclusion that the only thing that really helped me during menopause was taking care of myself, and not allowing all the stressful factors that were going on in my life to continue."

Now aged 57, Annie added: "If you think about it at this age it can be really stressful. There aren't so many opportunities at work, or if you're single, and there's so much stigma in ageing for a woman that you've got all these pressures and stresses and that then has a massive impact.

"Self-care is not taught in schools, it's not taught anywhere really, so you spend your life taking care of other people.

"You have partners that need rescuing, you maybe do too much for your kids, you take on your friends problems - I also did that.

"So my sense of self worth and value came from helping other people and solving their problems and that makes you very useful to people.

"But the trouble is you're not very good at solving your own problems, and that works fine in life until you get to menopause, and then your body changes, your hormones change and everything starts to shut down."

Annie's series of events will begin on Monday at The Oast Community Centre in Rainham, from 6.30pm to 8.30pm.

Guest speakers will include a menopause nurse, a nutritionist, a fitness specialist and a reflexologist.

The event, with a capacity of 100 people, has almost sold out and Annie's said she has been inundated with emails.

"It really is an indicator of how much this is needed," she added.

Annie plans to hold events in Gravesend, Dartford, Bexleyheath, Rochester, Chatham and Gillingham, with dates still to be announced via her website https://anniecardone.co.uk/.

Her book, called Menopause WTH! will be released in the next few weeks.

She said: "I really want to share the information that Ive researched and studied for eight or nine years now with women who have nowhere else to go.

"It's not about selling a book, it's not about promoting myself I'd rather be invisible.

"It's not a comfortable situation for me, telling a story is incredibly hard especially when it's to do with mental health. It isn't an easy thing to do but I feel like if I do nothing then that's irresponsible, and I want to help women."

Originally posted here:
'Menopause treatment hell and how I ended up in hospital six times' - Kent Online

The FDA has approved Kyzatrex, an oral testosterone replacement therapy for the treatment of adult males with conditions associated with hypogonadism.1

The approval was based on results from the multicenter, open-label phase 3 Study MRS-TU-2019EXT (NCT04467697). The study enrolled 155 hypogonadal males. According to the study design, The primary efficacy end point was the percentage of KYZATREX-treated patients with mean plasma total testosterone concentration over 24-hours within the normal range of 222-800 ng/dL on the final PK visit of the study at day 90.2

Of the total patient population, 139 patients were eligible for the efficacy analysis The median patient age was 50 years (range, 22-66). Regarding race, 79% of patients were White, 16% were Black, 3% were Asian, and 2% were American Indian, Alaskan Native, or other.

Overall, 88% (122/139) of patients reached the primary study end point. The key secondary endpoints were the percentage of patients who had a maximum total testosterone

concentration that met 3 predetermined limits: 1.5 times the upper limit of normal range (ULN; 1200 ng/dL); 1.8-2.5 times ULN (1440-2000 ng/dL); and >2.5 times ULN (2000 ng/dL). At the final PK visit, these percentages were determined to be88%, 4%, and 0%, respectively.

The mean duration of treatment exposure was 168 days (range, 1-180). The only adverse event occurring in 2% of patients was hypertension, which was reported in 4 (2.6%) of 155 patients.

With so many men suffering daily effects of Testosterone Deficiency and often abandoning or not electing to get treatment, we see FDA-approved Kyzatrex as a newly viable oral option that has demonstrated safety and effectiveness. Further, Testosterone Deficiency is a big blind spot in medicine today and our research will continue to explore the importance of testosterone in both male and female health, Shalin Shah, CEO of Marius, the developer of Kyzatrex, stated in a news release.

References

1. Marius Pharmaceuticals Receives FDA Approval of KYZATREX, an Oral Testosterone Replacement Therapy. Published online August 2, 2022. Accessed August 3, 2022. https://bit.ly/3OUA0Cx

2. FDA prescribing label for Kyzatrex (testosterone undecanoate) capsules, for oral use. Accessed August 3, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213953s000lbl.pdf

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FDA approves oral testosterone replacement therapy for hypogonadism - Urology Times

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The U.S.Food and Drug Administrationhas had a busy week, accepting drug applications, approving clinical trials and granting various special designations. Continue reading for more details.

Bayerreceived a nod from the FDA for the use of Nubeqa (darolutamide) in combination with docetaxel chemotherapy for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC). This follows a previous approvalof Nubeqa in non-metastatic castration-resistant prostate cancer (nmCRPC). The newest approval isbased on the Phase III ARASENS trial, which studied Nubeqa plus androgen deprivation therapy (ADT) and docetaxel compared to ADT and docetaxel.

The FDA approvedDaiichi SankyoandAstraZenecas ENHERTUfor another indication. It is now approved for the treatment of adult patients with a range of HER2 expressions, including those with unresectable or metastatic HER2 low breast cancer. This additional indication was based on theDESTINY-Breast04Phase III trial.

Gamida Cell Ltd.announcedthat the FDA accepted its Biologics License Application for omidubicel. The therapy is being developed for the treatment of patients with blood cancers who need an allogeneic hematopoietic stem cell transplant.

Cellectisreportedthe FDA cleared its Investigational New Drug (IND) application to initiate a Phase I/IIa trial of UCART20x22 for patients with relapsed or refractory Non-Hodgkin Lymphoma (r/r NHL). UCART20x22 features TALEN-mediated disruptions of the TRAC gene and of the CD52 gene.

Scynexisannouncedthat the FDA accepted its sNDA for Brexafemme for the treatment of vulvovaginal candidiasis (WC) and the prevention of recurrent WC. It was accepted for Priority Review with a PDUFA date of November 30, 2022.

The Janssen Pharmaceutical Companies of Johnson & Johnsonannouncedthe FDA approved Stelara (ustekinumab) for the treatment of children six and older with active psoriatic arthritis (PsA). The drug is a fully human monoclonal antibody that selectively inhibits IL-12 and IL-23.

Krystal Biotechreportedthat the FDA had accepted its IND application for KB407 for cystic fibrosis. KB407 is a modified HSV-1 vector carrying two copies of the CF transmembrane conductance regulator (CFTR) gene to the respiratory cells in the lungs.

Beam Therapeuticsannouncedthe FDA placed a clinical hold on its IND application for BEAM-201 for relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL)/T cell lymphoblastic lymphoma (T-LL). No reason for the hold was supplied. BEAM-201 is a donor-derived CAR-T cell therapy that has undergone multiplex base editing to become universally compatible and resistant to rejection by the host.

Celyad Oncologyreportedthe FDA has lifted its clinical hold on the Phase Ib KEYNOTE-B79 trial. The hold was placed in February after two patient deaths. CYAD-101 is an allogeneic CAR-T cell therapy designed to express the NKG2D receptor, generally found on NK cells, and the novel inhibitory peptide TIM. It is being tested with Mercks Keytruda.

Marius Pharmaceuticalsannouncedthat the FDA approved Kyzatrex (testosterone undecanoate) as an oral testosterone replacement therapy for adult males for conditions associated with deficiency or absence of endogenous testosterone (hypogonadism).

MAIA BiotechnologyreceivedOrphan Drug Designation from the FDA for THIO. THIO is a telomere-targeting agent in development for multiple cancers, including small-cell lung cancer.

BiosightwasgrantedOrphan Drug Designation by the FDA for asparcytarabine for treatment of myelodysplastic syndromes. Asparcytarabine is a novel proprietary anti-metabolite made up of cytarabine covalently bound to asparagine.

Calidi Biotherapeuticsannounced thatCity of HopereceivedFDA authorization to proceed with a Phase I trial of Calidis oncolytic virotherapy platform, NSC-CRAd-S-pk7. The therapy is made up of tumor-tropic neural stem cells delivering an oncolytic adenovirus selectively to tumor sites in patients with recurrent high-grade glioma.

Twist BioscienceandBiotias EUA for its Next-Generation Sequencing Assay for SARS-COV-2receivedexpanded authorization.

Avenge Bioannouncedthe FDA cleared its IND for AVB-001 in peritoneal malignancies. The drug is designed to secrete native IL-2 in immune-activating alginate capsules.

Amylyx Pharmaceuticalsreportedthat the FDAs Peripheral and Central Nervous System Drugs Advisory Committee will reconvene to review its NDA for AMX0035 (sodium phenylbutyrate and taurursodiol) for ALS. It previously met on March 30 but is reconvening to discuss additional data analysis.

Allergan Aesthetics, an AbbVie company,announcedthe FDA approved Juvederm Volux XC for the improvement of jawline definition in adults over the age of 21 with moderate to severe loss of jawline definition.

AnHeart TherapeuticsreceivedBreakthrough Therapy Designation from the FDA for taletrectinib for adults with advanced or metastatic ROS-1-positive non-small cell lung cancer (NSCLC) who are ROS1 TKI treatment nave or previously treated with crizotinib. Taletrectinib is a ROS-1 inhibitor.

OliX Pharmaceuticalss IND for OLX10212 wasapprovedfor age-related macular degeneration. OLX10212 targets inflammation pathways that play a key role in geographic atrophy and neovascular AMD. It is for a Phase I trial.

Sumitomo Pharma Oncologyreportedthe FDA granted Orphan Drug Designation for DSP-5336 for acute myeloid leukemia. The drug is a small molecule inhibitor against the binding of minin and mixed-lineage leukemia (MLL) protein.

Pulse Biosciencesannouncedthey had received FDA clearance of expanded energy settings for use with the family of CellFX System treatments tips in dermatology. CellFX System uses the companys Nano-Pulse Stimulation technology to deliver electrical energy to clear cells.

Vaxcytereportedthe FDA granted Fast Track designation to VAX-24, its 24-valent pneumococcal conjugate vaccine candidate for adults 18 and older.

GenBody Americaannouncedthat the FDA granted an extension of the shelf life for its COVID-19 Ag (antigen) test from 12 months to 21 months when stored at 2 to 30 degrees C (35-86 degrees F).

Acadia Pharmaceuticalsannouncedthey had received a Complete Response Letter from the FDA for its sNDA for Nuplazid (pimavanserin) for the treatment of hallucinations and delusions associated with Alzheimers disease psychosis (ADP). The agency recommended that the company run another trial in ADP.

ProfoundBioreceivedthe go-ahead from the FDA for its IND to evaluate PRO1184 in patients with advanced cancer in a Phase I trial. The drug is an antibody-drug conjugate made up of a folate receptor alpha directed antibody conjugated to an exatecan payload with a proprietary hydrophilic linker.

Continued here:
FDA Weekly Review: Gamida Cell, Cellectis, Scynexis and More - BioSpace

Wilmington, Delaware, United States, Transparency Market Research Inc.: According to Transparency Market Researchs latest report on the global testosterone replacement therapy market for the historical period 20172018 and forecast period 20192027, increasing incidence of testosterone deficiency, growing awareness among people regarding testosterone replacement therapy and significant pipeline of medications, are projected to drive the global testosterone replacement therapy market during the forecast period

According to the report, the global testosterone replacement therapy market was valued at US$ 1,613.7 Mn in 2018 and is anticipated to expand at a CAGR of 4.4% from 2019 to 2027

Rising incidence of testosterone deficiency: Key Drivers

Testosterone deficiency, also known as hypogonadism, is characterized by diminished functioning of the male gonads that reduces testosterone secretion. This occurs mainly due to hypothalamic-pituitary axis dysfunction and/or testicular failure.

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Testosterone deficiency is one of the common health problems among men aged between 40 years and 79 years. The incidence of low testosterone levels in men aged over 60 years is estimated to be around 20% of the male population, and in population aged over 70 years, around 30%. The global prevalence of testosterone deficiency ranges from over 10% to 40% of the population.

However, only around 9% patients with testosterone deficiency are being treated in the U.S. This is due to factors such as perceived risk of prostate cancer associated with current treatment therapy and lack of screening/tests for low testosterone. Therefore, increase in incidence rate of testosterone deficiency is expected to drive the testosterone replacement therapy products market in the near future.

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Rise in Geriatric Population with High Risk of Testosterone Deficiency Boost Market Growth

The world population is aging rapidly, especially in some of the developed economies such as the U.S., most of Western Europe, and Japan. Developed economies present high rates of aging. This is attributed to improved health care infrastructure, policies, and advancement in health care facilities in these countries. Moreover, access to various diagnostic and treatment services has improved in the recent past especially in developed economies. This in turn has increased the life expectancy of the population.

According to World Health Organization (WHO) estimates, the global geriatric population is likely to reach around 2 billion (22% of global population) by 2050 as compared to 524 million in 2010. The geriatric population would rise at the fastest rates in developed countries such as the U.K, Germany, the U.S., and Japan. However, Brazil, China, Thailand, and South Korea are also expected to have a large geriatric population base in shortest span of time in the near future.

Testosterone levels decrease naturally as age increases beyond 30 years. However, in some cases significant decrease can lead to health problems. World population is rapidly aging. Therefore, with increasing population of age individuals the testosterone deficient men population would also grow, which in turn would increase the demand for testosterone replacement therapy in the global market. Hence, increase in the geriatric population is expected to fuel the growth of the testosterone replacement therapy market globally.

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Patent Expiry of Key Drugs and Entry of Generics Hamper Market

The testosterone replacement therapy market is expected to experience a patent cliff during the forecast period. Expiration of key drug patents would affect the revenues of large pharmaceutical companies from TRT products. In addition, the generic versions of these drugs would further reduce the global market revenues as these would be priced much lower than their counterparts (branded drugs) that dominated the global market earlier.

This factor is expected to have a profound effect on the overall testosterone replacement therapy products market, causing a drastic dip in market revenues. Moreover, approved ANDAs for most of these molecules will lead to intense generic competition.

Therefore, patent expirations are likely to significantly impact and restrain the testosterone replacement therapy market in the near future.

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Global Testosterone replacement therapy Market: Competitive Landscape

This report profiles major players in the global testosterone replacement therapy market based on various attributes such as company overview, financial overview, product portfolio, business strategies, and recent developments

The global testosterone replacement therapy market is highly consolidated, with top five players accounting for over 60% of the market.

Leading players operating in the global testosterone replacement therapy market are

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Testosterone Replacement Therapy Market: Increasing Incidence of Testosterone Deficiency to Drive the Market - BioSpace

Becky Maynard has spent 10 years working in many international humanitarian crises, dealing with everything from earthquakes to refugees, and then did a Masters in Disaster Management. Consequently, you might expect her to be more resilient than most in dealing with the perils of the perimenopause, but like so many women, she was knocked sideways by mystery symptoms.

Her problems began when she was 44, driving home to Cornwall, and pulled her car over three times. I kept thinking I was having a stroke or a heart attack, says Maynard, now 48. I drew into a lay-by, realising there was no way I could drive any further because I was going to die.

She asked a lorry driver parked nearby to help, saying, I dont know whats happening. I cant be alone. He tried some breathing exercises with her and called a friend. Three hours later, she managed to drive herself home.

She wondered if she was suffering from PTSD from her work, was diagnosed with panic attacks and offered cognitive behavioural therapy, which didnt help much. Then she was given antidepressants: [They] made no difference. I continue to have constant anxiety, gain weight and feel utterly miserable. When she began to suspect her problems might be linked to hormones, she asked about hormone replacement therapy [HRT], but her GP told her to come back two years after your periods have stopped.

But Maynard had been on a pill that meant she was not having periods. So she started researching her symptoms and discovered they are common in the years leading up to menopause. Its been a revelation finding out about perimenopause, and Ive decided to see a different GP to discuss HRT, she said.

Perimenopause is menopauses dastardly little sister. On no account should it be underestimated, as it moves by stealth. Women in their forties find themselves flummoxed by a raft of mental and physical symptoms, and blame themselves instead of their changing hormones, because they usually still have their periods.

Until recently, there was silence and ignorance around perimenopause among women and even doctors, and only now is it beginning to get the attention it needs. If you looked on the NHS website three months ago, there was only one vague mention of the word perimenopause, but now (in a slight improvement) the site describes symptoms of perimenopause and menopause as one item.

But the emotional and physical rollercoaster of perimenopause needs far more explanation than that: it is a time of anxiety, sleeplessness and physical change for most. Suicide peaks among women, and divorce rises. In midlife, usually when women are in their mid-to-late forties, oestrogen and progesterone unpredictably drain and refill like rip tides, and then decline along with testosterone, which is also a female hormone. Every day can be different.

It is not merely the onlookers, families and friends that dont realise whats going on. Women themselves (along with some non-binary people and trans men who go through this process) often have no idea. Perimenopause can seriously affect mental health.

I am the producer of two recent Davina McCall menopause documentaries for Channel 4, and it was the perimenopause rather than the menopause that caused havoc in the TV presenters life. McCall was 44 when she started getting hot flushes, anxiety and brain fog that stopped her reading the autocue: I thought I had early onset dementia, she said.

For me, the perimenopause brought peculiar symptoms: terrifying heart palpitations in the early hours and overwhelming anxiety, as well as sudden gaps in my memory bank. The heart palpitations led to an electrocardiogram, which was just fine Im a regular runner. The doctor concluded the cause was too much coffee. Menopause was never mentioned, but the palpitations disappeared and my memory rebooted as soon as I sought out HRT.

I was so astonished at the lack of reliable information that I wrote a book, Everything You Need to Know About the Menopause (but were too afraid to ask) and discovered there were huge gaps in research, particularly around perimenopause. I only found out how common some of my own symptoms were after we commissioned a Channel 4/Fawcett Society poll of 4,000 women aged 45-55 for the second programme, Davina McCall: Sex, Mind and the Menopause. It turned out that 41 per cent had experienced difficulties with heart palpitations, and 73 per cent had brain fog and memory problems.

With menopause coming on average at 51 (though it can be younger, particularly for Black and Asian women) it was important to include women in their late forties in the poll, and what resonated was that 69 per cent suffered anxiety and depression, and 84 per cent sleeplessness. There was one other key finding 44 per cent said they had uncomfortably heavy periods in perimenopause. These flooding, tsunami-style periods stop some women leaving the house, and others need more access to the bathroom at work.

Theres no one-size-fits-all set of symptoms that define perimenopause, say nutritionist Emma Bardwell and menopause specialist Dr Shahzadi Harper in their book, The Perimenopause Solution. Hot flushes are not always the signifier. NHS guidelines say that women under 45 can be given a blood test to see if their hormones are low. But if your blood test comes back normal, you might think you cant possibly be in perimenopause. What you need to know is this: its not about the numbers, its about how you feel.

Bardwell and Harper say: Many GPs are still reluctant to prescribe hormone replacement therapy to women in perimenopause who still have their periods, even when symptoms are signalling hormonal change and a call for help.

As Becky Maynard found, perimenopause is often not identified as a possible cause of mental-health symptoms. That means women may miss out on effective treatment for their anxiety or depression.

Menopausal depression is different from clinical depression, and usually responds to hormones. Patients who have never previously been depressed describe low mood, a grey, flat kind of feeling, a loss of joy, said Dr Rebecca Lewis, a GP turned menopause specialist at the Newson Heath Menopause and Wellbeing Centre in Stratford-Upon-Avon. The reason women come to see me most in the clinic is not the hot flushes, not the muscle pains, but the psychological changes. As eggs begin to run out in perimenopause, that starts fluctuations in hormones which affect the brains limbic system, which governs anxiety, mood, libido and concentration.

So what can women do if they suspect they are perimenopausal? Obviously paying attention to lifestyle choices really matters and Bardwell points out that changing hormones can cause bloating and even alcohol intolerance. A diet overhaul is a good idea, looking after your gut microbiome and making sure you get enough vegetables, vitamin D, fish oils and even magnesium, which can help with sleep.

Exercise has also been shown to reduce hot flushes, but nothing can replace lost hormones except hormones themselves, and the new body-identical HRT available on the NHS is safer than the older preparations. A body-identical progesterone pill and transdermal oestrogen in a patch, gel or spray showed no increased risk of breast cancer in a 2022 study of almost half a million womens records in the UK databank.

One of the best resources, with more detailed information than the NHS website, is the balance-menopause.com website, and the free Balance app. Balances chief executive Gaele Lalahy explains: The app allows users to track their symptoms and print an individualised health report which they can take to their doctor. More than 250,000 health reports have been downloaded, and more than half of women who had been using the app for more than five months said it had helped them to access treatment faster.

We need to empower women with accurate information, and in turn improve their physical and mental health, as well as their quality of life.

Weve had period power. Now we need to talk about the perimenopause power and take control of our hormones.

Everything You Need to Know About the Menopause (but were too afraid to ask) by Kate Muir (Gallery Books, 16.99) is out now

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'I kept thinking I was having a heart attack but it was the perimenopause' - iNews

Gilbert, AZ Men are constantly looking for ways to improve their overall health and well-being. In recent years, Gilbert testosterone therapy has become a popular treatment option that gives them the boost that they need to feel stronger, more energetic, and more confident.

One medical clinic that is leading the way in providing testosterone therapy is Limitless TRT & Aesthetics, LLC. As the name suggests, this medical clinic was founded with the belief that men can always improve and push their limits, no matter their age. It is dedicated to helping them reach their maximum potential in every area of their lives. Whether theyre looking to improve their energy levels and muscle mass, feel more confident in the bedroom, or enhance their overall health and well-being.

Limitless TRT & Aesthetics, LLC offers a wide range of services and treatments to help patients achieve their goals. Testosterone Replacement Therapy (TRT) is one of the most popular services offered at the clinic. This treatment is ideal for patients who are suffering from low testosterone levels due to aging or other factors. TRT can help to improve energy levels, libido, and muscle mass in men who are struggling with these issues. Patients who undergo this treatment at Limitless TRT & Aesthetics, LLC can expect a significant improvement in their quality of life.

Having a small penis can be incredibly embarrassing for men to deal with. It can cause performance anxiety and relationship problems. Fortunately, Limitless TRT & Aesthetics, LLC offers a solution for this issue as well. The experienced physicians and enhancement specialists at the clinic offer various non-surgical, minimally invasive in-office male enhancement procedures that can help patients to achieve the results theyre looking for. These procedures include penile glans (head of the penis) enlargement, penile girth enlargement, and scrotal enhancement. The procedures are safe, effective, and require minimal downtime. Patients can expect to see permanent results from these treatments within a short period of time after their appointment.

Those struggling with self-esteem and confidence issues due to sexual performance problems also dont have to suffer any longer. When they choose Limitless TRT & Aesthetics, LLC, they will receive personalized treatment that is specifically tailored to address their unique needs. The experienced specialists at the clinic have the solutions needed to help patients achieve their sexual performance goals. They will go over each treatment option with the patient to make sure that they get the best results possible.

The clinics dedication to helping patients reach their maximum potential extends beyond helping them improve their sexual health as they also offer aesthetic services to help them look and feel their best. Some of these services include botox, cryolipolysis, facial fillers, HIFEM, and more. These services are designed to eliminate the signs of aging, including excess fat deposits, age spots, sagging skin, and wrinkles.

Limitless TRT & Aesthetics, LLC is committed to providing its patients with the highest quality of care possible. To that end, it offers concierge services to make sure that its patients can get the medications they need quickly and easily. And because the clinic only works with licensed professionals, patients can be sure that theyre getting the best possible care.

Limitless TRT & Aesthetics, LLC is located at 3483 S Mercy Rd Suite 104, Gilbert, AZ, 85297, US. Interested persons can contact their team at 1-480-400-0105. For more information regarding services offered, visit their website.

Media Contact

Company NameLimitless TRT & Aesthetics, LLCPhone1-480-400-0105Address3483 S Mercy Rd Suite 104CityGilbertStateArizonaPostal Code85297CountryUnited StatesWebsitehttps://limitlesstrtandaesthetics.com/

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Limitless TRT & Aesthetics, LLC Offers Testosterone Therapy in Gilbert, AZ - Digital Journal