low libido Archives - Dr. Scott Rennie

Update, September 18, 2026: What Came Out of the FDA Workshop

The workshop happened yesterday. Nothing was approved, and approval was never on the table. What changed was the tone. Admiral Brian Christine, the Assistant Secretary for Health, opened by calling the lack of an FDA-approved testosterone product for women “unacceptable” when Australia has one. The FDA’s own position was more measured: the approval standard is the same for every drug, data from other countries will be judged case by case, and the agency says it stands ready to review an application (10).

That last point matters most. Nothing changes for patients until a company actually files. Products made for women are already approved in the UK, Australia, New Zealand and South Africa, so the data exists. The question is whether anyone brings it here.

The science presented matched what I wrote below. Dr. Rajita Patil of UCLA’s menopause program said the evidence supports testosterone for postmenopausal women with low sexual desire and is insufficient for mood, cognition or general well-being. She also cautioned against oral testosterone because of what it does to cholesterol (10).

My own practice hasn’t changed. Until there’s an approved product I can prescribe, I refer patients out. Public comments are open until October 19, 2026.

On September 17, 2026, the FDA holds its first public workshop on testosterone use in menopausal women. It is a hybrid session, in person at the agency’s White Oak campus and online at the same time, filed under docket FDA-2026-N-5479, with the public comment period open through October 19 (1). Right now, no testosterone product is FDA-approved for use in women in the United States. Every prescription written for a woman is off-label, borrowed from a product built and dosed for men. When I think a patient would benefit, my role right now is to refer her to someone who can prescribe it, not to write it myself.

That gap has been widening for a decade, and the FDA is only now catching up to it.

Why the Agency Is Paying Attention Now

Prescribing tells the story better than any regulatory notice could. Testosterone prescriptions to women in the US rose roughly 2.6-fold between 2016 and 2025, from 50.0 to 130.8 per 100,000 eligible women (2). In 2025 alone, 90,482 prescriptions went out, up 58.7 percent from the year before. About three in five, 62.2 percent, went to women between 45 and 64. More than half, 51.2 percent, already carried at least one documented cardiometabolic risk factor (2).

Rapid off-label growth in a population that already carries meaningful cardiovascular risk, for a drug whose long-term safety in women is still not established: that combination is what put a federal workshop on the calendar.

The Evidence That Actually Holds Up

Low sexual desire is where testosterone has real trial support. A 2019 systematic review and meta-analysis by Islam and colleagues in The Lancet Diabetes & Endocrinology pooled 36 randomized controlled trials and 8,480 women (3). In postmenopausal women, testosterone significantly improved desire, arousal, orgasm, and sexual pleasure, and reduced the distress that comes with low libido. The Global Consensus Position Statement, released the same year, reached the same conclusion from a different angle: the only evidence-based indication for testosterone therapy in women is hypoactive sexual desire disorder, confirmed only after a genuine biopsychosocial assessment rules out the other usual explanations, a strained relationship, untreated depression, a medication doing this to her (4).

I put it this way when the subject came up this week:

“Low desire is where the evidence is strongest, and that alone is reason not to dismiss it. A lot of women also just feel better on it. We cannot fully explain why yet, but at a physiologic dose with honest counseling about what is proven, that is a reasonable place to stand.”

What the Data Still Cannot Explain

The same Islam review found no measurable effect of testosterone on general wellbeing, cognition, body composition, or musculoskeletal outcomes. No real change in bone density. No change in lean mass or strength. The consensus statement says it plainly: no effect on general wellbeing has been demonstrated in trials to date.

That sits awkwardly next to what a lot of women report once they are actually on it: more energy, sharper focus, a sense of being back in their own body. That reported experience deserves to be taken seriously rather than waved off, and I am not going to claim an energy or cognition benefit I cannot point to a trial for either. The evidence has not caught up to the experience yet.

What a Reasonable Dose Looks Like

The goal is a physiologic premenopausal testosterone level. The dose I would want a patient on is about one-tenth of the standard male dose of a regulated 1 percent testosterone gel, roughly 5 mg applied to the skin daily, off-label since nothing is approved for women. Pellets and high-dose injections push levels into supraphysiologic territory that a properly dosed gel does not reach. Compounded products are a different problem: no consistent evidence backs their dosing, efficacy, or safety, whatever the label promises (4).

Monitoring is not complicated. Check a baseline total testosterone level, recheck at three to six weeks to confirm the dose landed where it should, and stop by six months if there is no symptomatic benefit. Formulation matters for one specific reason: oral testosterone raises LDL cholesterol, while a transdermal patch or gel leaves the lipid panel essentially untouched. Side effects run mild and cosmetic more often than dangerous, acne and unwanted hair growth chief among them. The same 2019 review also recorded an overall increase in weight with testosterone treatment. Worth knowing if weight is already part of the conversation.

Where Estrogen Usually Fits First

Estrogen treats hot flashes, night sweats, disrupted sleep, and vaginal dryness, none of which testosterone has been shown to fix, and it has a much longer safety record behind it. When I treat patients, estrogen usually comes before testosterone.

Without a need for contraception, the regimen I reach for is transdermal 17-beta-estradiol 0.025 to 0.05 mg per day, paired with micronized progesterone 100 mg nightly, continuously, if she still has a uterus. With a need for contraception, I use continuous ethinyl estradiol 20 mcg with levonorgestrel 100 mcg daily instead. About a quarter of the women I see on video visits arrive already started on hormone therapy from somewhere else, so a fair amount of my job is auditing a regimen I did not write.

Flibanserin, sold as Addyi, is worth knowing about too. On December 15, 2025, the FDA expanded its approval to cover postmenopausal women under 65 with HSDD; before that it had only been approved for premenopausal women, since 2015 (5). It is a separate, FDA-approved option aimed specifically at low desire rather than at hormone levels.

Getting Any of This Through a Screen

Testosterone is a Schedule III controlled substance. Under the DEA and HHS telemedicine flexibilities extended through December 31, 2026, a DEA-registered practitioner can currently prescribe it after a video visit alone, with no prior in-person exam, and generally without a separate DEA registration in the patient’s state, as long as both states’ laws allow it (6, 7). That is temporary: it rests on an extension already renewed four times, and the permanent replacement, a special-registration system that would keep Schedule III drugs like this one in an easier tier than Schedule II, has been in White House OMB review since August 25, 2026 with no final version yet (8, 9).

So federal law is not what stops me right now. Some telemedicine platforms do let a DEA-registered clinician prescribe controlled substances after a video visit. The platforms I work through don’t give me that ability at the moment, so when I think a patient would genuinely benefit, I refer her to an in-person clinician who can prescribe it. If that changes, or the DEA’s pending rule settles things for good, I may be able to write it myself.

For Patients

Before a video visit about this, bring your current medications and any hormone therapy already written down. Know what has changed for you, specifically, rather than a general “I don’t feel like myself.” And say what you want treatment to do: “I want my desire back” and “I want more energy” point toward different conversations, and only one has real trial data behind it.

One red flag worth knowing: pellets. The consensus statement is direct about this. Any testosterone preparation that produces supraphysiologic levels, pellets and high-dose injections included, is not recommended, in part because there is no way to adjust or remove the dose once a pellet is implanted. If a clinic is pitching pellets alongside language about restoring youthful vitality, that is worth questioning.

For Colleagues

A total testosterone level should never be the test that diagnoses HSDD. It does not correlate reliably with symptoms; this is a clinical diagnosis built on history and distress, other causes ruled out along the way. There is no data supporting use in premenopausal women, so keep the indication where the evidence lives, and screen for cardiometabolic risk before starting anything, given how much of the current prescribing population already carries it (2).

The Bottom Line

Low desire is where the evidence for testosterone is strongest in postmenopausal women, and that alone is reason not to dismiss it. Many women report feeling better on it, and nobody can fully explain why yet. If I were prescribing, the dose would be physiologic: about one-tenth of the standard male dose of a regulated 1 percent gel, roughly 5 mg on the skin daily, and estrogen usually comes first. Right now I am not the one writing that prescription. Testosterone is a Schedule III controlled substance, and the platforms I work through don’t currently let me prescribe it, so when a patient would benefit, I refer her to an in-person clinician who can. That could change once the DEA finalizes its pending rule or my platforms add the capability. The comment window on the FDA’s workshop closes October 19, 2026.

Sources

1. FDA. Public Meeting: Testosterone Use in Menopausal Women. September 17, 2026. Docket FDA-2026-N-5479. https://www.fda.gov/consumers/womens-health-events/fda-public-meeting-testosterone-use-menopausal-women-09172026

2. Avivi I, Stuenkel CA, Sampath-Kumar R, Ben-Yehuda O. Accelerating Testosterone Prescribing for U.S. Women: Implications for Cardiovascular Safety. JACC Adv. 2026;5(6 Pt 1):102724. PMID 42095794. https://pmc.ncbi.nlm.nih.gov/articles/PMC13309321/

3. Islam RM, Bell RJ, Green S, Page MJ, Davis SR. 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. PMID 31353194. https://pubmed.ncbi.nlm.nih.gov/31353194/

4. Davis SR, Baber R, Panay N, et al. Global Consensus Position Statement on the Use of Testosterone Therapy for Women. J Clin Endocrinol Metab. 2019;104(10):4660-4666. PMID 31498871. https://pmc.ncbi.nlm.nih.gov/articles/PMC6821450/

5. Historic First in Women’s Sexual Health: FDA Grants Approval for Addyi (flibanserin) in Postmenopausal Women. BioSpace, December 15, 2025. https://www.biospace.com/press-releases/historic-first-in-womens-sexual-health-fda-grants-approval-for-addyi-flibanserin-in-postmenopausal-women

6. Fourth Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Substances. Federal Register, December 31, 2025. https://www.federalregister.gov/documents/2025/12/31/2025-24123/fourth-temporary-extension-of-covid-19-telemedicine-flexibilities-for-prescription-of-controlled

7. Drug Enforcement Administration, Diversion Control Division. Telemedicine: State Registration Q&A (EO-DEA192, DEA-DC-044). https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-044)(EO-DEA192)_Telemed_State_Reg_QA_(Final).pdf

8. Special Registrations for Telemedicine and Limited State Telemedicine Registrations. Federal Register, January 17, 2025. https://www.federalregister.gov/documents/2025/01/17/2025-01099/special-registrations-for-telemedicine-and-limited-state-telemedicine-registrations

9. DEA Prescribing of Controlled Substances via Telemedicine. Alliance for Connected Care. https://connectwithcare.org/dea-prescribing-of-controlled-substances/

10. Mahatole S, Ananthan P. US regulators urge more research on testosterone therapy for women. Reuters (via GV Wire), September 17, 2026. https://gvwire.com/2026/09/17/us-regulators-urge-more-research-on-testosterone-therapy-for-women/

Editor’s note, August 2026. This post predates the TRAVERSE trial, reported in 2023, which found no increase in major cardiovascular events with testosterone therapy in men with hypogonadism and existing cardiovascular risk. The cautious framing below reflects what was known in 2013.

Low testosterone is a hot topic right now in primary care. Recent advertisements are on television discussing various testosterone treatments available to men with “Low T.” I’ve recently had quite a few patients asking me to check testosterone levels and then they usually have questions about testosterone treatments if the blood levels are abnormal. Testosterone is a hormone that is produced in both men and women, but it is usually present at higher levels in men. The consequences of low serum testosterone are not known for certain but there are several possible symptoms of low levels including (research is still being done):

Low sex drive, erectile dysfunction, poor morning erection
Fatigue
Being slow to go through puberty (if it is too low during childhood)
Decreased bone mineral density
Decreased muscle mass
Decreased muscle strength
Anemia
Decreased mood
Decreased cognitive function

Of course there are other, more common causes of low sex drive and fatigue that can affect grown men instead of low testosterone levels. Experts believe that the current trials have demonstrated weak and indirect inferences about the usefulness of testosterone for osteoporosis in men. Testosterone levels naturally decrease as men age. This normal decline in testosterone however has not had established clinical consequences. We are still studying the effect that the natural decline of testosterone levels have in the body. Elderly men often ask if they should be prescribed supplemental testosterone to keep their levels from decreasing. The answer is difficult because we currently do not entirely understand whether the changes in body generally associated with aging (decreased muscle mass, decreased energy) may be related to naturally decreasing testosterone levels or even if treatment with testosterone reverses the decreasing muscle mass and energy we see in the average person with increasing age. We’re also concerned about adverse consequences of testosterone with diseases that are testosterone dependent such as prostate cancer. Controversy regarding testosterone whether to prescribe testosterone therapy: A committee of the Institute of Medicine of the National Academy of Sciences Committee reviewed available studies and concluded that no beneficial effects of administering testosterone have been well established. The Endocrine Society however has published evidence based guidelines for testosterone therapy in adult men with deficiency of testosterone. The guidelines from the Endocrine society are:

Testosterone therapy should be prescribed only for men with low serum testosterone levels on more than one test and who have symptoms of testosterone deficiency and have no known pituitary or testicular disease.
In order to minimize the potential risk of causing testosterone-dependent diseases, the target level of testosterone level in the blood should be between 300-400 ng/dL (10.4 to 13.9 nmol/L)

The Institute of Medicine’s committee on testosterone concluded that there is insufficient evidence to conclude that testosterone treatment of elderly men has any well-established benefit thus far on improving muscle strength, physical function, vitality, sexual function, cognition and quality of life. They recommended further investigation. Potential to cause harm: High testosterone levels has the potential to cause cancer of the prostate but data are limited. The common practice in treating prostate cancer is to lower serum testosterone levels with medications. Screening for low testosterone: One approach has been the following:

If a male has symptoms of possible testosterone deficiency such as decreased sex drive, energy, mood or osteoporosis or anemia a serum testosterone level can be checked early in the morning (before 8am when normal testosterone levels are highest). If the level is low, it should be repeated for confirmation.
Free testosterone levels should only be evaluated in men who have obesity.
If testosterone levels (both times) is less than 200 ng/dL (6.9 nmol/L) evaluation for causes of hypogonadism can be performed. If there is no pituitary or testicular disease, discuss with the patient about possible treatment with supplemental testosterone (ie. Benefits vs risks).

Testosterone treatment: One approach to treatment has been the following:

If treatment is started and the symptoms that led to measuring the testosterone are not corrected (improved energy, sex drive, anemia, etc.) within a few months then discontinuing the testosterone treatment can be considered.
Before starting treatment, a digital rectal exam should be performed and a PSA (prostate specific antigen) measured. If a man has higher than normal PSA with no identifiable risk factors a urological evaluation should be performed before any testosterone therapy is started.
3 months after starting the testosterone treatment, a digital rectal exam and PSA should be repeated. If there is a prostate nodule or the PSA has increased more than 1.4ng/mL (and confirmed) urological consult should be sought. If the PSA and digital rectal exam is not considered abnormal, the digital rectal exam and PSA should be performed once a year (just as with any man).

References: Bhasin S, Cunningham GR, Hayes FJ, Matsumoto AM, Snyder PJ, Swerdloff RS, Montori VM, Task Force, Endocrine Society. Testosterone therapy in men with androgen deficiency syndromes: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2010 Jun;95(6):2536-59. I hope that you have found this information useful. Wishing you the best of health,

Dr. Scott Rennie

Tag: low libido

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