In 2022, Aisha Kabia started to experience symptoms she originally thought could be long COVID: brain fog, fatigue, and joint pain. As an actor based in Los Angeles, she was used to memorizing huge chunks of dialogue, but she suddenly needed a teleprompter for routine performances.
After screenings requested by her gynecologist and endocrinologist came back negative, a nurse practitioner ordered a hormonal blood panel. Women are born with about a tenth of the amount of testosterone in their bodies as men, and it wanes over time. At 42, Kabia was told she had undetectable levels of testosterone, and her NP prescribed her a testosterone cream to boost her levels. That, Kabia said, ended up being the "key" that made her feel "whole" again.
"I feel like I got my life back," Kabia told MedPage Today. "Slowly but surely over the next year, I got my brain and my muscles back. Everything came back online."
There is debate within the medical community as to whether testosterone should be prescribed to women during menopause and the time before and after it.
In theory, androgen insufficiency and hormonal changes in menopause can cause sexual dysfunction, so getting testosterone levels back to their mid-reproductive age levels may be able to help alleviate these symptoms. Kelly Casperson, MD, a urologist and menopause specialist based in Bellingham, Washington, told MedPage Today that women "have way more testosterone than estrogen in their bodies" so it "makes logical sense to give a woman testosterone in menopause as her ovaries decrease their production of both testosterone and estrogen."
But other physicians say there is a lack of long-term data to support its safety and efficacy in this patient population and that it shouldn't be prescribed until a product for this purpose has been approved by the FDA.
Some are especially critical of influencers and other media personalities touting testosterone as a cure-all for mood and cognitive changes, fatigue, reduced muscle strength, and other symptoms associated with menopause. Although testosterone's effect on outcomes like bone density in postmenopausal women is being studied, research on these other outcomes is lacking.
In 2019, a group of medical societies including the International Menopause Society, the International Society for the Study of Women's Sexual Health (ISSWSH), and the Endocrine Society found the only indication with enough evidence to support testosterone in women was hypoactive sexual desire disorder (HSDD), in which a lack of sexual desire is causing a patient distress.
"It would be nice to have some longer-term data so that we could have a better understanding of the risks and benefits of testosterone in women," Stephanie Faubion, MD, director of the Mayo Clinic Center for Women's Health and medical director of the Menopause Society, told MedPage Today. "Unfortunately, we just don't have that right now, which is partly why it's not FDA-approved."
A few testosterone formulations, all designed to treat HSDD, have gone before the FDA. Ever since Viagra was approved in 1998, drugmakers have been searching for a similar treatment for women's sexual dysfunction -- although some argue that it's unclear what "normal" levels of sexual desire are among women and that drugmakers are trying to pathologize them for profit.
In 2004, the FDA reviewed a testosterone patch from Procter & Gamble called Intrinsa. Although the patch was associated with improvement in the number of sexual experiences for women, it was rejected due to a lack of long-term data and safety concerns. In 2010, BioSante Pharmaceuticals applied for approval of a testosterone gel called LibiGel, but it wasn't approved due to a higher-than-anticipated placebo response.
When asked to elaborate on why these two products were not approved, the FDA told MedPage Today in an email that the agency is generally unable to discuss existing or potential applications and that the data requested was confidential commercial information. Neither Procter & Gamble or BioSante Pharmaceuticals responded to a request for comment as of press time.
"The decision to treat a patient with a drug for an unapproved use is up to the treating healthcare professional," an FDA spokesperson wrote in an email. "Generally speaking, the practice of medicine is not regulated by the FDA."
Around the time that these drugs went through the review process, the 2002 Women's Health Initiative study found women given estrogen had an increased risk of cancer and cardiovascular disease. Research conducted since then has challenged those findings, and the tide seems to be turning again, particularly for certain menopause symptoms like hot flashes and night sweats. Regardless, the original 2002 findings may be contributing to some providers' hesitancy to prescribe testosterone for postmenopausal women off-label.
"You end up having hesitancy [among providers] for a variety of reasons," Sharon Parish, MD, an internist at Weill Cornell Medicine in New York City, told MedPage Today. "It's not easy to prescribe testosterone to women."
Further complicating things is the fact that testosterone is a Schedule III controlled substance along with drugs like ketamine, meaning providers are required to adhere to additional dispensing laws when prescribing it. Accurately detecting testosterone levels in women can also be challenging in the first place. Although liquid chromatography-mass spectrometry assays are sensitive enough to detect lower testosterone levels, the more common and economic laboratory radioimmunoassay has been reported to have challenges with sensitivity.
Regardless, there is no standardization of levels considered "low," that could help doctors diagnose whether a woman needs treatment anyway, said James Simon, MD, a women's sexual health specialist at George Washington University in Washington, D.C., who has been writing about using testosterone for this purpose for a decade.
"If you send a testosterone test for your average woman, whatever her age is, and you don't specify, you get the quick and dirty man's test applied to the woman," Simon told MedPage Today. "You might as well throw a dart at a dartboard."
Some say the lack of an FDA-approved product is pushing women to use men's formulations purchased out-of-pocket at compounding pharmacies, which can be hard to dose and lead to unwanted side effects like hair growth or, in severe cases, clitoral enlargement or voice changes.
Because testosterone for postmenopausal women is an off-label treatment, it's unclear how prescription patterns have changed in recent years in the U.S. However, national data from the U.K. suggest a 10-fold increase in the number of women over 50 prescribed testosterone between 2015 and 2022.
Australia is the only country in which a testosterone product has been approved for women.
Although menopause has been having a moment, it has been largely misunderstood and understudied for years both in and outside of the medical community. A 2023 review published in Cell found that 85% of women in high-income countries don't receive adequate treatment for menopausal symptoms, and a 2022 paper published in Menopause found two-thirds of residency programs surveyed did not have a menopause curriculum.
The first two doctors Kabia went to with her symptoms suggested more exercise and a better diet to help her feel better. But she was already exercising, eating well, and even working on daily mental health practices like meditation. She had heard women on testosterone anecdotally reporting that it helped with some of the same symptoms she had, and she felt like she didn't have many other options.
"Menopause is a normal part of a woman's life cycle," Kabia said. "The suffering piece is the part that is not."
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.