By Nelson Vergel | B.S. Chemical Engineering, MBA | Founder, ExcelMale.com | 34+ years on TRT | NIH and FDA advisory panel service | Author: Testosterone: A Man's Guide, Beyond Testosterone, The Peptide Consensus
Curated By Nelson Vergel | ExcelMale.com | Updated July 2026
Roughly 12% of women meet the clinical threshold for female sexual dysfunction once personal distress is factored in. The strongest evidence-based treatment for postmenopausal hypoactive sexual desire disorder is testosterone, endorsed by a joint global consensus of 11 medical societies. And there is no product on a US pharmacy shelf that a doctor can legally prescribe for it by label.
That gap is not an accident of science. The trials were run. The drugs worked, at least by the standard the drugs were measured against. What happened was a collision between a modest effect size, a regulatory agency badly spooked by the Women's Health Initiative, and a commercial calculation that the market was not worth the cost of proving safety over a decade. Understanding how each attempt failed tells you more about what women can actually get today than any dosing chart will.
Intrinsa was a transdermal patch delivering 300 mcg of testosterone per day. Procter and Gamble filed its New Drug Application in 2004, seeking approval for hypoactive sexual desire disorder in surgically menopausal women, meaning women who had undergone bilateral oophorectomy and were already on estrogen therapy. The FDA granted it Fast Track status.
On December 2, 2004, the advisory committee voted unanimously to recommend against approval.
The panel's reasoning came down to a ratio. On the benefit side, the registration trials enrolled 1,095 women and produced a statistically significant increase in satisfying sexual events. Reviewers translated that into roughly one additional satisfying sexual event per month above placebo. On the risk side sat a question nobody could answer: what does adding an androgen to estrogen therapy do to cardiovascular risk and breast cancer risk over ten or twenty years? The trials ran six months. They enrolled a few hundred women each. No excess of heart attacks or cancers showed up, but the panel did not consider the absence of a signal in a six-month trial to be evidence of long-term safety.
Timing mattered enormously here. The Women's Health Initiative had been halted in 2002 when the estrogen-plus-progestin arm showed increased breast cancer incidence. That study had nothing to do with testosterone. It did not test testosterone. But it detonated inside the regulatory culture surrounding female hormone therapy, and by December 2004 any panel looking at a hormone for women was looking at it through WHI-shaped glasses.
Procter and Gamble withdrew the application later that month rather than take a formal rejection. The company announced plans to run larger trials including naturally menopausal women and refile. That refiling never happened.
LibiGel was a once-daily 300 mcg testosterone gel, and BioSante went at the problem with more resources than anyone before or since. The company enrolled roughly 1,172 women across two Phase III efficacy trials and simultaneously ran a five-year cardiovascular and breast cancer safety study enrolling 3,656 subjects. That safety study was the direct answer to the objection that sank Intrinsa. BioSante was doing exactly what the FDA said the field needed.
In December 2011, BioSante reported that both efficacy trials had missed their primary endpoints.
The drug arm improved. So did the placebo arm, by nearly as much. The placebo response in female sexual desire trials is notoriously large, which makes clinical sense once you consider what is actually happening: a woman enrolls in a study, discusses her sexual function with a clinician for the first time in years, receives regular attention and a treatment she believes may work, and starts paying deliberate attention to her own desire. Some of that produces real improvement whether or not the gel contains hormone. BioSante's trials could not separate signal from that noise.
The company cut 25% of its workforce, abandoned its NDA plans, and eventually ran out of money. The five-year safety study, the one that might have finally settled the cardiovascular question, was never completed in a form that reached regulators as part of an approval package. This is the part of the story that gets overlooked: the single largest safety dataset ever assembled for testosterone in women was collateral damage from an efficacy failure.
Two regulators have said yes. One later reversed itself.
The European Medicines Agency authorized Intrinsa on July 28, 2006, for HSDD in surgically menopausal women on concurrent estrogen therapy, an indication that excluded naturally menopausal women entirely because no trials in that population had been submitted. In August 2009, the company applied to broaden the indication to all menopausal women with HSDD, then withdrew that extension application in September 2010, citing commercial considerations. On May 25, 2012, the Intrinsa marketing authorization was formally withdrawn across the EU. The stated reason was poor sales.
Australia is the exception that still stands. Lawley Pharmaceuticals obtained TGA registration for AndroFeme 1, a 1% testosterone cream, on November 20, 2020, indicated for HSDD in postmenopausal women with associated personal distress. It reached Australian pharmacies in April 2021. AndroFeme is the most-studied formulation in female HSDD trials and it is the only testosterone therapy on earth currently approved and marketed for women.
Off-label prescribing is legal. Physicians have been giving women testosterone this way for more than fifty years, and Dr. Kelly Casperson makes the point bluntly on the ExcelMale forum that many experts believe roughly as many women as men receive testosterone in the US. So if the drug is available anyway, what is the harm in the FDA never blessing it?
Four things, and they are not trivial.
Insurance will not cover it. An off-label prescription for a non-approved indication is a cash expense, which quietly restricts testosterone therapy to women who can afford to pay out of pocket.
There is no standardized dose. Because no approved female product exists, clinicians improvise: a fraction of a male gel sachet, a compounded 1% cream, a sublingual troche, or a very small injection. A member on the ExcelMale HRT in Women forum reported that his 62-year-old wife does well on 4 to 5 mg of testosterone cypionate weekly split into two injections, after creams gave her erratic blood levels. That is a reasonable protocol. It is also one man's experience, published on a forum, standing in for the dosing guidance a label would have provided.
Compounded products have no potency oversight. ACOG has been explicit that compounded hormone preparations lack FDA quality control and that dosing can be inconsistent. The organization specifically recommends against testosterone pellets in women, because once a pellet is implanted the dose cannot be lowered without surgical removal, and androgen excess from a pellet can be difficult to reverse.
Research stays fragmented. Without an approved product, there is no sponsor with a financial incentive to fund the long-term outcome trials that would answer the cardiovascular and breast cancer questions the 2004 panel raised. The absence of approval perpetuates the evidence gap that justified the absence of approval.
Yes. Off-label prescribing is legal and routine across medicine. The FDA regulates what manufacturers may market a drug for, not what physicians may prescribe it for. A woman being prescribed compounded testosterone cream is not doing anything illegal, and neither is her doctor. What she does not have is a product tested and labeled for her body at a dose established through registration trials.
On January 26, 2026, Aviva Bio announced it had received formal FDA feedback in a Type B meeting on the development requirements for AVA-291, a testosterone therapy designed specifically for women. This is the first meaningful regulatory movement on female testosterone in the US in over a decade.
AVA-291 is d3-testosterone, a deuterium-substituted isotopologue. Selected hydrogen atoms in the testosterone molecule are replaced with deuterium, producing a compound that is structurally testosterone and retains androgen receptor activity, but resists aromatization to estradiol. The rationale targets the exact fear that killed Intrinsa: local aromatization of testosterone within breast tissue is one proposed mechanism linking androgen therapy to breast cancer risk. Data accepted for presentation at the AACR Annual Meeting in April 2026 show AVA-291 has roughly 1,000-fold less potential to stimulate breast cancer cell proliferation compared with ordinary testosterone.
Two cautions belong here, and I want to be direct about them.
First, this is preclinical cell-proliferation data plus a regulatory meeting, not a clinical trial result. A Phase 1 trial was planned for early 2026. A Type B meeting means the FDA told the company what it would need to demonstrate, and the FDA explicitly acknowledged breast cancer risk as the central safety issue. That is not the same as a signal that approval is coming.
Second, a non-aromatizing testosterone raises a real question for women that nobody has answered yet. Aromatization to estradiol is not purely a liability in female physiology. Postmenopausal women derive estrogen partly through peripheral conversion of androgens, and a testosterone that will not aromatize gives up whatever benefit that conversion provides. Whether that trade is favorable is an empirical question, and the trials to answer it have not been run.
The December 2004 advisory committee voted unanimously against approval on the grounds that the demonstrated benefit, roughly one additional satisfying sexual event per month versus placebo, did not justify unresolved long-term risks of cardiovascular events and breast cancer. The trials had run only six months, which the panel considered too short to establish safety. Procter and Gamble withdrew the application rather than receive a formal rejection.
Australia. The TGA registered AndroFeme 1, a 1% testosterone cream, on November 20, 2020, for HSDD in postmenopausal women with associated personal distress. Europe approved Intrinsa in 2006 but the authorization was withdrawn in 2012. The US has never approved a testosterone product for women.
Yes, through off-label prescribing of male-approved formulations at reduced doses, or through compounding pharmacies. This is legal but not FDA-approved, which means insurance typically does not cover it and no standardized dose exists.
AVA-291 (d3-testosterone) is a deuterium-substituted testosterone from Aviva Bio, engineered to resist aromatization into estradiol and thereby reduce the breast cancer concern that has blocked prior approvals. The FDA issued development pathway guidance in January 2026 and a Phase 1 trial was planned for early 2026. It is years from any approval decision, and no human efficacy data exist yet.
The WHI tested estrogen plus progestin, not testosterone. It was halted in 2002 over increased breast cancer incidence, and the resulting alarm reshaped how regulators and physicians evaluated every female hormone therapy that followed, including testosterone. The 2004 Intrinsa panel cited concerns rooted in that trial even though the WHI never studied the drug in front of them.
Here is the thing the regulatory record makes clear that no clinic website will tell you: the modest effect size that sank Intrinsa in 2004 is the same effect size that today's global consensus statement calls evidence-based and recommends. Nothing about the underlying biology changed between the FDA panel voting it down and 11 international medical societies endorsing it. What changed was who was doing the weighing, and what they were weighing it against. A regulator asks whether a benefit is large enough to justify approving a drug for millions of women with unknown decade-long risks. A woman with HSDD asks whether it is large enough to matter to her. Those are different questions, and they can honestly produce different answers from identical data.
If you are a woman considering testosterone, or a man trying to help his partner navigate this, the practical implication is that you are working without a safety net that exists in almost every other area of prescription medicine. Test with a sensitive assay, dose to the low end of the female physiologic range, and reassess at six months. For the underlying treatment options, see the Practical Clinical Summary on Testosterone Therapy in Women, and for the community's ongoing collection of research on this question, the Testosterone Therapy in Pre- and Post-Menopausal Women deep dive is where the primary literature gets posted as it appears.
ExcelMale.com is a men's health forum with more than 24,000 members and over 20 years of archived discussion on testosterone replacement therapy, hormone optimization, sexual health, peptides, and women's hormone health. Founded by Nelson Vergel, chemical engineer, 34-year TRT patient, and patient advocate with NIH and FDA advisory panel experience, ExcelMale provides evidence-based information that bridges clinical research and real-world experience.
Nelson Vergel is the author of Testosterone: A Man's Guide, Beyond Testosterone, and The Peptide Consensus. He is also the founder of DiscountedLabs.com, a resource for affordable direct-to-consumer hormone and health laboratory testing.
Curated By Nelson Vergel | ExcelMale.com | Updated July 2026
Roughly 12% of women meet the clinical threshold for female sexual dysfunction once personal distress is factored in. The strongest evidence-based treatment for postmenopausal hypoactive sexual desire disorder is testosterone, endorsed by a joint global consensus of 11 medical societies. And there is no product on a US pharmacy shelf that a doctor can legally prescribe for it by label.
That gap is not an accident of science. The trials were run. The drugs worked, at least by the standard the drugs were measured against. What happened was a collision between a modest effect size, a regulatory agency badly spooked by the Women's Health Initiative, and a commercial calculation that the market was not worth the cost of proving safety over a decade. Understanding how each attempt failed tells you more about what women can actually get today than any dosing chart will.
What Happened When Procter and Gamble Tried to Get the Intrinsa Testosterone Patch Approved?
Intrinsa was a transdermal patch delivering 300 mcg of testosterone per day. Procter and Gamble filed its New Drug Application in 2004, seeking approval for hypoactive sexual desire disorder in surgically menopausal women, meaning women who had undergone bilateral oophorectomy and were already on estrogen therapy. The FDA granted it Fast Track status.
On December 2, 2004, the advisory committee voted unanimously to recommend against approval.
The panel's reasoning came down to a ratio. On the benefit side, the registration trials enrolled 1,095 women and produced a statistically significant increase in satisfying sexual events. Reviewers translated that into roughly one additional satisfying sexual event per month above placebo. On the risk side sat a question nobody could answer: what does adding an androgen to estrogen therapy do to cardiovascular risk and breast cancer risk over ten or twenty years? The trials ran six months. They enrolled a few hundred women each. No excess of heart attacks or cancers showed up, but the panel did not consider the absence of a signal in a six-month trial to be evidence of long-term safety.
Timing mattered enormously here. The Women's Health Initiative had been halted in 2002 when the estrogen-plus-progestin arm showed increased breast cancer incidence. That study had nothing to do with testosterone. It did not test testosterone. But it detonated inside the regulatory culture surrounding female hormone therapy, and by December 2004 any panel looking at a hormone for women was looking at it through WHI-shaped glasses.
Procter and Gamble withdrew the application later that month rather than take a formal rejection. The company announced plans to run larger trials including naturally menopausal women and refile. That refiling never happened.
Why Did BioSante's LibiGel Fail Its Phase III Trials?
LibiGel was a once-daily 300 mcg testosterone gel, and BioSante went at the problem with more resources than anyone before or since. The company enrolled roughly 1,172 women across two Phase III efficacy trials and simultaneously ran a five-year cardiovascular and breast cancer safety study enrolling 3,656 subjects. That safety study was the direct answer to the objection that sank Intrinsa. BioSante was doing exactly what the FDA said the field needed.
In December 2011, BioSante reported that both efficacy trials had missed their primary endpoints.
The drug arm improved. So did the placebo arm, by nearly as much. The placebo response in female sexual desire trials is notoriously large, which makes clinical sense once you consider what is actually happening: a woman enrolls in a study, discusses her sexual function with a clinician for the first time in years, receives regular attention and a treatment she believes may work, and starts paying deliberate attention to her own desire. Some of that produces real improvement whether or not the gel contains hormone. BioSante's trials could not separate signal from that noise.
The company cut 25% of its workforce, abandoned its NDA plans, and eventually ran out of money. The five-year safety study, the one that might have finally settled the cardiovascular question, was never completed in a form that reached regulators as part of an approval package. This is the part of the story that gets overlooked: the single largest safety dataset ever assembled for testosterone in women was collateral damage from an efficacy failure.
Which Countries Have Approved a Testosterone Product for Women?
Two regulators have said yes. One later reversed itself.
The European Medicines Agency authorized Intrinsa on July 28, 2006, for HSDD in surgically menopausal women on concurrent estrogen therapy, an indication that excluded naturally menopausal women entirely because no trials in that population had been submitted. In August 2009, the company applied to broaden the indication to all menopausal women with HSDD, then withdrew that extension application in September 2010, citing commercial considerations. On May 25, 2012, the Intrinsa marketing authorization was formally withdrawn across the EU. The stated reason was poor sales.
Australia is the exception that still stands. Lawley Pharmaceuticals obtained TGA registration for AndroFeme 1, a 1% testosterone cream, on November 20, 2020, indicated for HSDD in postmenopausal women with associated personal distress. It reached Australian pharmacies in April 2021. AndroFeme is the most-studied formulation in female HSDD trials and it is the only testosterone therapy on earth currently approved and marketed for women.
| Product | Sponsor | Region | Outcome |
|---|---|---|---|
| Intrinsa (300 mcg/day patch) | Procter and Gamble | US (FDA) | Advisory panel voted unanimously against; NDA withdrawn Dec 2004 |
| Intrinsa (300 mcg/day patch) | Warner Chilcott | EU (EMA) | Approved July 2006 for surgical menopause; withdrawn May 2012 |
| LibiGel (300 mcg/day gel) | BioSante | US (FDA) | Phase III efficacy failed Dec 2011; NDA never filed |
| AndroFeme 1 (1% cream) | Lawley Pharmaceuticals | Australia (TGA) | Approved November 2020; on market since April 2021 |
| AVA-291 (d3-testosterone) | Aviva Bio | US (FDA) | FDA development guidance issued January 2026; Phase 1 planned |
What Does the Missing Approval Actually Cost Women?
Off-label prescribing is legal. Physicians have been giving women testosterone this way for more than fifty years, and Dr. Kelly Casperson makes the point bluntly on the ExcelMale forum that many experts believe roughly as many women as men receive testosterone in the US. So if the drug is available anyway, what is the harm in the FDA never blessing it?
Four things, and they are not trivial.
Insurance will not cover it. An off-label prescription for a non-approved indication is a cash expense, which quietly restricts testosterone therapy to women who can afford to pay out of pocket.
There is no standardized dose. Because no approved female product exists, clinicians improvise: a fraction of a male gel sachet, a compounded 1% cream, a sublingual troche, or a very small injection. A member on the ExcelMale HRT in Women forum reported that his 62-year-old wife does well on 4 to 5 mg of testosterone cypionate weekly split into two injections, after creams gave her erratic blood levels. That is a reasonable protocol. It is also one man's experience, published on a forum, standing in for the dosing guidance a label would have provided.
Compounded products have no potency oversight. ACOG has been explicit that compounded hormone preparations lack FDA quality control and that dosing can be inconsistent. The organization specifically recommends against testosterone pellets in women, because once a pellet is implanted the dose cannot be lowered without surgical removal, and androgen excess from a pellet can be difficult to reverse.
Research stays fragmented. Without an approved product, there is no sponsor with a financial incentive to fund the long-term outcome trials that would answer the cardiovascular and breast cancer questions the 2004 panel raised. The absence of approval perpetuates the evidence gap that justified the absence of approval.
Is It Legal for a Doctor to Prescribe Testosterone to a Woman in the US?
Yes. Off-label prescribing is legal and routine across medicine. The FDA regulates what manufacturers may market a drug for, not what physicians may prescribe it for. A woman being prescribed compounded testosterone cream is not doing anything illegal, and neither is her doctor. What she does not have is a product tested and labeled for her body at a dose established through registration trials.
What Is Changing in 2026?
On January 26, 2026, Aviva Bio announced it had received formal FDA feedback in a Type B meeting on the development requirements for AVA-291, a testosterone therapy designed specifically for women. This is the first meaningful regulatory movement on female testosterone in the US in over a decade.
AVA-291 is d3-testosterone, a deuterium-substituted isotopologue. Selected hydrogen atoms in the testosterone molecule are replaced with deuterium, producing a compound that is structurally testosterone and retains androgen receptor activity, but resists aromatization to estradiol. The rationale targets the exact fear that killed Intrinsa: local aromatization of testosterone within breast tissue is one proposed mechanism linking androgen therapy to breast cancer risk. Data accepted for presentation at the AACR Annual Meeting in April 2026 show AVA-291 has roughly 1,000-fold less potential to stimulate breast cancer cell proliferation compared with ordinary testosterone.
Two cautions belong here, and I want to be direct about them.
First, this is preclinical cell-proliferation data plus a regulatory meeting, not a clinical trial result. A Phase 1 trial was planned for early 2026. A Type B meeting means the FDA told the company what it would need to demonstrate, and the FDA explicitly acknowledged breast cancer risk as the central safety issue. That is not the same as a signal that approval is coming.
Second, a non-aromatizing testosterone raises a real question for women that nobody has answered yet. Aromatization to estradiol is not purely a liability in female physiology. Postmenopausal women derive estrogen partly through peripheral conversion of androgens, and a testosterone that will not aromatize gives up whatever benefit that conversion provides. Whether that trade is favorable is an empirical question, and the trials to answer it have not been run.
Frequently Asked Questions
Why did the FDA reject the Intrinsa testosterone patch for women?
The December 2004 advisory committee voted unanimously against approval on the grounds that the demonstrated benefit, roughly one additional satisfying sexual event per month versus placebo, did not justify unresolved long-term risks of cardiovascular events and breast cancer. The trials had run only six months, which the panel considered too short to establish safety. Procter and Gamble withdrew the application rather than receive a formal rejection.
Is testosterone therapy for women approved anywhere in the world?
Australia. The TGA registered AndroFeme 1, a 1% testosterone cream, on November 20, 2020, for HSDD in postmenopausal women with associated personal distress. Europe approved Intrinsa in 2006 but the authorization was withdrawn in 2012. The US has never approved a testosterone product for women.
Can American women legally get testosterone?
Yes, through off-label prescribing of male-approved formulations at reduced doses, or through compounding pharmacies. This is legal but not FDA-approved, which means insurance typically does not cover it and no standardized dose exists.
What is AVA-291 and could it become the first FDA-approved testosterone for women?
AVA-291 (d3-testosterone) is a deuterium-substituted testosterone from Aviva Bio, engineered to resist aromatization into estradiol and thereby reduce the breast cancer concern that has blocked prior approvals. The FDA issued development pathway guidance in January 2026 and a Phase 1 trial was planned for early 2026. It is years from any approval decision, and no human efficacy data exist yet.
Why does the Women's Health Initiative still matter for testosterone approval?
The WHI tested estrogen plus progestin, not testosterone. It was halted in 2002 over increased breast cancer incidence, and the resulting alarm reshaped how regulators and physicians evaluated every female hormone therapy that followed, including testosterone. The 2004 Intrinsa panel cited concerns rooted in that trial even though the WHI never studied the drug in front of them.
Conclusion
Here is the thing the regulatory record makes clear that no clinic website will tell you: the modest effect size that sank Intrinsa in 2004 is the same effect size that today's global consensus statement calls evidence-based and recommends. Nothing about the underlying biology changed between the FDA panel voting it down and 11 international medical societies endorsing it. What changed was who was doing the weighing, and what they were weighing it against. A regulator asks whether a benefit is large enough to justify approving a drug for millions of women with unknown decade-long risks. A woman with HSDD asks whether it is large enough to matter to her. Those are different questions, and they can honestly produce different answers from identical data.
If you are a woman considering testosterone, or a man trying to help his partner navigate this, the practical implication is that you are working without a safety net that exists in almost every other area of prescription medicine. Test with a sensitive assay, dose to the low end of the female physiologic range, and reassess at six months. For the underlying treatment options, see the Practical Clinical Summary on Testosterone Therapy in Women, and for the community's ongoing collection of research on this question, the Testosterone Therapy in Pre- and Post-Menopausal Women deep dive is where the primary literature gets posted as it appears.
Related ExcelMale Forum Discussions
- Testosterone Therapy in Pre- and Post-Menopausal Women: Deep Dive - Nelson Vergel's comprehensive evidence review covering indications, dosing, and the full regulatory history of failed approval attempts.
- Key Historical Failures and Lessons Learned from Attempts to Get a Testosterone Product FDA-Approved for Women - Focused breakdown of what went wrong with Intrinsa and LibiGel and what it means for future applicants.
- Practical Clinical Summary on Testosterone Therapy in Women - Clinical extraction covering physiologic rationale, dosing forms, and monitoring targets for women on testosterone.
- Testosterone Therapy in Women with Testosterone Insufficiency - The Traish and Morgentaler review arguing the medical community has failed to adopt testosterone therapy for women despite evidence dating to the 1940s.
- Global Consensus on Testosterone Therapy for Women - Discussion of the 2019 position statement from 11 medical societies and what it does and does not endorse.
- The Use of Testosterone in Women: Is It Worth It and Safe? - Nelson Vergel's foundational 2013 article on female testosterone, written while LibiGel was still in play.
- Benefits of Testosterone for Post-Menopausal Women - Community thread collecting the evidence for testosterone benefits after menopause.
- Testosterone and Menopause: Every Woman Should Know This - Dr. Kelly Casperson on the absence of FDA-approved testosterone options for women and the inequity it creates.
- Testosterone in Women: Myths, Benefits, and Risks of HRT After Menopause - Deep dive with Professor Susan Davis on measurement accuracy, therapeutic dosing, and common misconceptions.
- Treatments That May Increase Sex Drive in Women - Early community thread on compounded options for women's libido.
- HRT in Women Subforum - The ExcelMale hub for all women's hormone therapy discussion.
Key References
- Islam RM, Bell RJ, Green S, et al. Safety and efficacy of testosterone for women: a systematic review and meta-analysis of randomised controlled trial data. Lancet Diabetes Endocrinol. 2019;7(10):754-766. DOI
- Davis SR, Baber R, Panay N, et al. Global Consensus Position Statement on the Use of Testosterone Therapy for Women. J Sex Med. 2019;16(9):1331-1337. DOI
- Shifren JL, Braunstein GD, Simon JA, et al. Transdermal testosterone treatment in women with impaired sexual function after oophorectomy. N Engl J Med. 2000;343(10):682-688. DOI
- Braunstein GD, Sundwall DA, Katz M, et al. Safety and efficacy of a testosterone patch for the treatment of hypoactive sexual desire disorder in surgically menopausal women: a randomized, placebo-controlled trial. Arch Intern Med. 2005;165(14):1582-1589. DOI
- Shifren JL, Davis SR, Moreau M, et al. Testosterone patch for the treatment of hypoactive sexual desire disorder in naturally menopausal women: results from the INTIMATE NM1 Study. Menopause. 2006;13(5):770-779. DOI
- El-Hage G, Eden JA, Manga RZ. A double-blind, randomized, placebo-controlled trial of the effect of testosterone cream on the sexual motivation of menopausal hysterectomized women with hypoactive sexual desire disorder. Climacteric. 2007;10(4):335-343. DOI
- Davis SR, Moreau M, Kroll R, et al. Testosterone for low libido in postmenopausal women not taking estrogen. N Engl J Med. 2008;359(19):2005-2017. DOI
- Parish SJ, Simon JA, Davis SR, et al. ISSWSH Clinical Practice Guideline for the Use of Systemic Testosterone for Hypoactive Sexual Desire Disorder in Women. J Sex Med. 2021;18(5):849-867. DOI
- Traish AM, Morgentaler A. Androgen Therapy in Women With Testosterone Insufficiency: Looking Back and Looking Ahead. Androgens. 2022;3(1). DOI
- Aviva Bio. FDA Guidance on Development Pathway for Women's Testosterone Therapy and New Evidence of Reduced Breast Cancer Cell Proliferation for AVA-291. January 26, 2026. Press release
- Urology Times. FDA provides guidance on development pathway for testosterone therapy for women. January 2026. Article
About ExcelMale
ExcelMale.com is a men's health forum with more than 24,000 members and over 20 years of archived discussion on testosterone replacement therapy, hormone optimization, sexual health, peptides, and women's hormone health. Founded by Nelson Vergel, chemical engineer, 34-year TRT patient, and patient advocate with NIH and FDA advisory panel experience, ExcelMale provides evidence-based information that bridges clinical research and real-world experience.
Nelson Vergel is the author of Testosterone: A Man's Guide, Beyond Testosterone, and The Peptide Consensus. He is also the founder of DiscountedLabs.com, a resource for affordable direct-to-consumer hormone and health laboratory testing.
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