Testosterone Therapy in Women: What the 2019 Global Consensus Reports

By Benn Bluestein-Veyra, M.Sc. Organic Chemistry · Updated 8 November 2026

ExaVeyra Sciences is a Miami-based B2B supplier of exosomes for topical aesthetic use to licensed clinics, and it refers licensed prescribers to a 503A compounding pharmacy that prepares formulations against individual prescriptions.

What this page covers, who can buy from ExaVeyra, and what is supplied
QuestionAnswer
What this page coversTestosterone therapy in women: what the 2019 Global Consensus found the evidence supports and lacks, the society guidance, and the FDA status in the US.
Who can orderLicensed clinics and practitioners whose active professional license and NPI ExaVeyra has verified. Exosome orders also require a signed professional-use acknowledgment.
What ships, and howCompounded formulations are prepared and dispensed by our 503A pharmacy partner against a patient-specific prescription from the licensed prescriber and ship from the pharmacy. The pharmacy dispenses any controlled substance under its own DEA registration.

The evidence on testosterone therapy in women was summarized in 2019 by a Global Consensus Position Statement endorsed by eleven societies, which concluded that "The only evidence-based indication for the use of testosterone in women is for the treatment of postmenopausal women who have been diagnosed as having HSDD after formal biopsychosocial assessment", that there are "insufficient data to support the use of testosterone for the treatment of any other symptom or clinical condition, or for disease prevention", and that "The safety of long-term testosterone therapy has not been established."[1] The statement rests on a meta-analysis of 36 randomized trials in 8,480 participants.[2] In the United States, FDA states that testosterone products "are FDA-approved only for use in men" who lack or have low testosterone with an associated medical condition, so every prescription of testosterone for a woman is off-label or compounded.[3]

This page reports what the consensus statement, the meta-analysis behind it, the Endocrine Society and the International Society for the Study of Women's Sexual Health state, and what the FDA record shows as of 8 November 2026.[1][3] Hypoactive sexual desire disorder (HSDD) appears here only as the population those documents and trials addressed.

The consensus was built on blinded randomized trials and endorsed by eleven societies

The statement opens with the problem it was written to address: "There are no clearly established indications for testosterone therapy for women", yet "clinicians have treated women with testosterone for decades", and in most countries women use "either testosterone formulations approved for men with dose modification, or compounded therapies."[1] A task force of representatives from international societies commissioned a systematic review and meta-analysis, met in Berlin on 17 May 2019 and reached "unanimous consensus agreement" on every expert opinion recommendation.[1]

The evidence base was narrow. Recommendations on benefit and risk "are based on findings from blinded placebo/comparator RCTs, of at least 12 weeks duration", each graded by level of evidence, and the clinical practice recommendations are labeled as expert opinion.[1] Its endorsers include the International Menopause Society, The Endocrine Society, The North American Menopause Society, the International Society for the Study of Women's Sexual Health and the Royal College of Obstetricians and Gynaecologists.[1]

The consensus names one evidence-based indication and limits it to physiological concentrations

Recommendation 12 carries the statement's central finding, graded Level I, Grade A: the only evidence-based indication is postmenopausal women diagnosed with HSDD "after formal biopsychosocial assessment."[1] Recommendation 4 describes the effect behind it. Testosterone "in doses that approximate physiological testosterone concentrations for premenopausal women" was reported to increase satisfying sexual events above placebo or comparator by "an average of one satisfying sexual event per month", with increases in desire, arousal, orgasmic function, pleasure and responsiveness and a reduction in sexual distress.[1]

The statement fences that finding in three ways. Because most trials "recruited women assessed as having HSDD or generalized FSD", the result "cannot be generalized to other subtypes of FSD or women without sexual dysfunction"; the recommendation "do[es] not apply to injectables, pellets, or formulations that result in supraphysiological blood concentrations of testosterone, or compounded preparations"; and a blood level plays no part in diagnosis, since "No cutoff blood level can be used for any measured circulating androgen to differentiate women with and without sexual dysfunction."[1]

The consensus lists the uses for which the evidence was insufficient or negative

For every other use the statement reported either no effect or too little data. It found "insufficient data to make any recommendations regarding the use of testosterone in premenopausal women for treatment of sexual function or any other outcome", insufficient evidence for cognitive performance, no effect on general wellbeing or depressed mood, no effect on bone mineral density at twelve months, and no statistically significant effect on lean body mass, total body fat or muscle strength.[1] It also stated that systemic dehydroepiandrosterone "cannot be recommended for women with HSDD."[1]

OutcomeFinding in the 2019 consensusEvidence label
Sexual function in postmenopausal women with HSDDBeneficial effect on satisfying events, desire, arousal, orgasm and distressLevel I, Grade A
Premenopausal women, any outcomeInsufficient data to make any recommendationInsufficient
Cognitive performance or cognitive declineInsufficient evidence to support useInsufficient
General wellbeingNo effect shownLevel I, Grade A
Depressed moodNo effect shownLevel I, Grade B
Bone mineral density at spine and hipNo effect at twelve monthsLevel I, Grade A
Lean mass, body fat, muscle strengthNo statistically significant effectLevel I, Grade A
Breast cancer preventionNo data to support useInsufficient
Myocardial infarction or deathLimited data preclude assessmentInsufficient

The Islam 2019 meta-analysis reported effects on sexual function and lipid differences by route

The meta-analysis commissioned for the consensus searched four databases and the regulatory submissions held by the European Medicines Agency and FDA for blinded randomized trials of at least twelve weeks completed between 1990 and December 2018, and retrieved 46 reports of 36 trials comprising 8,480 participants.[2] In postmenopausal women it reported an increase in satisfactory sexual event frequency (mean difference 0.85, 95% CI 0.52 to 1.18) and in sexual desire (standardized mean difference 0.36), with gains in pleasure, arousal, orgasm, responsiveness and self-image and reductions in sexual concerns and distress.[2]

On safety, the authors reported "A significant rise in the amount of LDL-cholesterol, and reductions in the amounts of total cholesterol, HDL-cholesterol, and triglycerides" with oral testosterone "but not when administered non-orally", an overall increase in weight, and "a significantly greater likelihood of reporting acne and hair growth, but no serious adverse events."[2] The authors concluded that long-term safety "warrant[s] further investigation."[2]

An earlier meta-analysis of seven trials of transdermal patches in 3,035 postmenopausal women reported more satisfying sexual episodes and more androgenic adverse events, acne and hair growth than placebo, with no significant difference in alopecia, voice deepening, total adverse events or serious adverse events.[4] A 2014 randomized trial in 71 hysterectomized women compared placebo with four testosterone dose groups and reported changes significantly greater than placebo only in the highest dose group, and its authors called for long-term trials.[5] An earlier landmark, a 2000 crossover trial of transdermal testosterone in 75 women after oophorectomy and hysterectomy, reported higher scores for frequency of sexual activity and pleasure-orgasm at the higher of two doses despite an appreciable placebo response.[6]

The consensus reports short-term safety findings and no data beyond 24 months

At physiological concentrations the statement reported "mild increases in acne and body/facial hair growth in some women, but not with alopecia, clitoromegaly, or voice change."[1] Oral testosterone "is associated with adverse lipid profiles" and "is not recommended"; nonoral therapies showed "no statistically significant adverse effects on lipid profiles over the short term"; blood pressure, glucose and HbA1c were not increased; and "A nonsignificant trend for an increased risk of deep venous thrombosis has been seen", with concurrent estrogen a possible contributor.[1] Testosterone did not increase mammographic density, short-term transdermal therapy was not reported to affect breast cancer risk, and trial data were "insufficient to assess long-term breast cancer risk."[1]

The panel qualified all of this. Trials "have excluded women at high cardiometabolic disease risk", most enrolled women taking estrogen, all were "of relatively short duration", and "Safety data for testosterone in physiologic doses are not available beyond 24 months of treatment."[1] The one large trial designed to answer the long-term question, a phase III study of a testosterone gel in postmenopausal women with HSDD and elevated cardiovascular risk, enrolled 3,656 women from January 2008; its ClinicalTrials.gov record lists it as completed in December 2012 with no results posted as of 8 November 2026.[7] Its published design named a composite of cardiovascular events as the primary end point and breast cancer as a coprimary end point, with follow-up planned for up to five years.[8]

The Endocrine Society guideline of 2014 set the same boundaries five years earlier

The Endocrine Society guideline, written with ACOG, the American Society for Reproductive Medicine, the European Society of Endocrinology and the International Menopause Society, continued "to recommend against making a diagnosis of androgen deficiency syndrome in healthy women because there is a lack of a well-defined syndrome."[9] It recommended against general use of testosterone for "infertility; sexual dysfunction other than hypoactive sexual desire disorder; cognitive, cardiovascular, metabolic, or bone health; or general well-being", and against routine prescription for women with low androgen levels from hypopituitarism, adrenal insufficiency, surgical menopause or glucocorticoid use, citing "no long-term studies of risk."[9]

The guideline found that "Evidence supports the short-term efficacy and safety of high physiological doses" in postmenopausal women with HSDD, that "endogenous T levels did not predict response to therapy", and that "physiological T preparations for use in women are not available in many countries including the United States, and long-term safety data are lacking." It recommended that "any woman receiving T therapy be monitored for signs and symptoms of androgen excess."[9]

The ISSWSH 2021 guideline adds a process of care and declines to recommend compounded products

The International Society for the Study of Women's Sexual Health issued a clinical practice guideline in 2021, built on the consensus statement and the Islam meta-analysis by a modified Delphi process.[10] It noted that the consensus endorses testosterone "for only postmenopausal women", while "limited data also support the use in late reproductive age premenopausal women"; it called the benefit "moderate" and stated that "long-term safety has not been established."[10]

The guideline states that "A total testosterone level should not be used to diagnose HSDD, but as a baseline for monitoring", that clinicians "should provide an informed consent" covering off-label use, and that "Compounded products cannot be recommended because of the lack of efficacy and safety data."[10] It names the regulatory gap as its own limitation: testosterone therapy "is not approved for women by most regulatory agencies, thereby making prescribing and proper dosing challenging."[10] The Latin American Association of Gynecological Endocrinology reached the same position in 2025, limiting therapy to HSDD confirmed through biopsychosocial evaluation and recommending against compounded bioidentical testosterone.[11]

FDA has approved no testosterone product for women in the United States

FDA's Testosterone Information page, current as of 23 June 2026, opens: "Testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition."[3] The agency's 28 February 2025 class-wide labeling statement uses the same language, describing testosterone as "approved solely for use in men".[12] The approved labels follow suit: section 5.7 of the AndroGel 1.62% label, revised 07/2025, is headed "Not for Use in Women" and states that "Due to the lack of controlled evaluations in women and potential virilizing effects", the product "is not indicated for use in women"; the label contraindicates use in pregnancy, carries a boxed warning on secondary exposure, and its abuse section lists hirsutism, virilization, deepening of voice, clitoral enlargement and menstrual irregularities among reactions reported in women.[13]

The one testosterone product for women to reach an FDA advisory committee was a transdermal system. The Federal Register notice for the 2 December 2004 meeting of the Advisory Committee for Reproductive Health Drugs states that the committee "will discuss new drug application (NDA) 21-769, Testosterone Transdermal System (proposed tradename, Intrinsa) by Procter and Gamble, indicated for the treatment of hypoactive sexual desire disorder in surgically menopausal women receiving concomitant estrogen therapy."[14] FDA's statements quoted above confirm that no testosterone product holds an approval for women as of 8 November 2026.[3][12] The products FDA has approved for HSDD are nonhormonal: the Addyi label, revised 12/2025, covers women less than 65 years of age with acquired, generalized HSDD, and the Vyleesi label covers premenopausal women and states that it "is not indicated for the treatment of HSDD in postmenopausal women".[15][16]

Testosterone remains a Schedule III controlled substance under 21 CFR 1308.13(f)(84), so the controlled substance rules described on the cluster's testosterone guidelines page apply to every prescription for a woman as well.[17]

The consensus and NASEM describe compounded testosterone for women as lacking evidence

The consensus addresses compounded testosterone directly: "Compounded “bioidentical” testosterone therapy cannot be recommended for the treatment of HSDD because of the lack of evidence for efficacy and safety, unless an authorized equivalent preparation is not available."[1] Where a compounded product is needed, "the compounding pharmacy should be compliant with purity of Active Pharmaceutical Ingredients and Good Manufacturing Practice", dosing "should be limited to achieving testosterone concentrations in the physiologic premenopausal range", and "Use of any testosterone preparation that results in supraphysiologic concentrations of testosterone, including pellets and injections, is not recommended."[1] For an approved male formulation the panel considered off-label prescribing "reasonable, provided hormone concentrations are maintained in the physiologic female range."[1]

The NASEM review that FDA commissioned covered testosterone among the compounded hormones it examined and assessed whether the evidence "would support marketing claims of the safety and effectiveness" of these preparations.[18] FDA summarizes its conclusion: NASEM "determined there was a lack of rigorous evidence of safety and effectiveness from well-designed or properly controlled clinical studies" and "concluded that their wide-spread use poses a public health concern."[19] The cluster's NASEM page reports the committee's findings on pellets and hormone testing in full.

What the consensus says a practice would document

The consensus and the ISSWSH guideline describe a sequence of assessment and monitoring that a prescribing practice would record.[1][10]

  • A formal biopsychosocial assessment and an HSDD diagnosis made against recognized criteria, with other contributing factors identified and addressed before testosterone is considered, as the consensus states.
  • A baseline total testosterone measured before starting, used as a monitoring baseline and never as the basis of diagnosis, which both documents state.
  • A repeat total testosterone three to six weeks after initiation, then clinical review for androgen excess with a serum total testosterone every six months to screen for overuse, as the consensus recommends.
  • A record of response, since the consensus states that treatment should be ceased if no benefit is experienced by six months.
  • Informed consent covering off-label use, benefits and risks, as the ISSWSH guideline describes.
  • Where a compounded preparation is prescribed, a record that no authorized equivalent was available, which is the exception the consensus names.

ExaVeyra's compounded hormone preparations reach a practice through a licensed 503A pharmacy partner on a patient-specific prescription. The partner dispenses testosterone and any other controlled substance under its own DEA registration and supplies a certificate of analysis for each lot on request. Diagnosis, the choice of product and the monitoring plan are decisions for the prescribing practitioner.[3][17]

This article summarizes publicly available federal regulation for licensed practitioner education. It is not legal advice, medical advice, or regulatory guidance, and it does not establish that any particular product or practice is compliant. Confirm current federal and state obligations with qualified counsel.

Annotated References

Numbered in the order they are cited in the text. Each source is annotated with what it supports on this page; peer-reviewed articles are listed with journal, volume, issue and pages, and primary sources are regulations, agency documents, guidelines and position statements.

  1. 1.Peer-reviewedDavis SR, Baber R, Panay N, Bitzer J, Perez SC, Islam RM, Kaunitz AM, Kingsberg SA, Lambrinoudaki I, Liu J, Parish SJ, Pinkerton J, Rymer J, Simon JA, Vignozzi L, Wierman ME. Global Consensus Position Statement on the Use of Testosterone Therapy for Women. Journal of Clinical Endocrinology and Metabolism. 2019;104(10):4660-4666. https://pubmed.ncbi.nlm.nih.gov/31498871/Annotation: The single evidence-based indication, the graded findings on every other outcome, the safety findings and their limits, the position on compounded products, pellets and injections, and the monitoring recommendations, quoted from the PMC full text.
  2. 2.Peer-reviewedIslam 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 and Endocrinology. 2019;7(10):754-766. https://pubmed.ncbi.nlm.nih.gov/31353194/Annotation: The meta-analysis behind the consensus: 36 trials, 8,480 participants, the sexual function effect sizes, the lipid differences between oral and nonoral routes, acne and hair growth, and the call for long-term safety data.
  3. 3.RegulatoryFDA, Testosterone Information (Postmarket Drug Safety Information for Patients and Providers; content current as of 23 June 2026). Accessed 8 November 2026. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/testosterone-information
  4. 4.Peer-reviewedAchilli C, Pundir J, Ramanathan P, Sabatini L, Hamoda H, Panay N. Efficacy and safety of transdermal testosterone in postmenopausal women with hypoactive sexual desire disorder: a systematic review and meta-analysis. Fertility and Sterility. 2017;107(2):475-482.e15. https://pubmed.ncbi.nlm.nih.gov/27916205/Annotation: Seven transdermal patch trials in 3,035 women: more androgenic adverse events, acne and hair growth than placebo and no difference in serious adverse events.
  5. 5.Peer-reviewedHuang G, Basaria S, Travison TG, Ho MH, Davda M, Mazer NA, Miciek R, Knapp PE, Zhang A, Collins L, et al. Testosterone dose-response relationships in hysterectomized women with or without oophorectomy: effects on sexual function, body composition, muscle performance and physical function in a randomized trial. Menopause. 2014;21(6):612-623. https://pubmed.ncbi.nlm.nih.gov/24281237/Annotation: Randomized trial in 71 hysterectomized women reporting changes greater than placebo only in the highest of four dose groups, and the authors' call for long-term trials.
  6. 6.Peer-reviewedShifren JL, Braunstein GD, Simon JA, Casson PR, Buster JE, Redmond GP, Burki RE, Ginsburg ES, Rosen RC, Leiblum SR, Caramelli KE, Mazer NA. Transdermal testosterone treatment in women with impaired sexual function after oophorectomy. New England Journal of Medicine. 2000;343(10):682-688. https://pubmed.ncbi.nlm.nih.gov/10974131/Annotation: Landmark crossover trial in 75 women after oophorectomy and hysterectomy, cited for its reported sexual function findings at the higher dose and its placebo response.
  7. 7.Official sourceClinicalTrials.gov, NCT00612742: Long-Term Safety and Efficacy of LibiGel for Hypoactive Sexual Desire Disorder in Postmenopausal Women. Accessed 8 November 2026. https://clinicaltrials.gov/study/NCT00612742
  8. 8.Peer-reviewedWhite WB, Grady D, Giudice LC, Berry SM, Zborowski J, Snabes MC. A cardiovascular safety study of LibiGel (testosterone gel) in postmenopausal women with elevated cardiovascular risk and hypoactive sexual desire disorder. American Heart Journal. 2012;163(1):27-32. https://pubmed.ncbi.nlm.nih.gov/22172433/Annotation: The published design of the long-term testosterone gel safety study: a cardiovascular composite primary end point, breast cancer as a coprimary end point and follow-up planned for up to five years.
  9. 9.Peer-reviewedWierman ME, Arlt W, Basson R, Davis SR, Miller KK, Murad MH, Rosner W, Santoro N. Androgen therapy in women: a reappraisal: an Endocrine Society clinical practice guideline. Journal of Clinical Endocrinology and Metabolism. 2014;99(10):3489-3510. https://pubmed.ncbi.nlm.nih.gov/25279570/Annotation: The Endocrine Society recommendations against diagnosing androgen deficiency in healthy women and against general use outside HSDD, the absence of physiological preparations for women in the United States, and monitoring for androgen excess.
  10. 10.Peer-reviewedParish SJ, Simon JA, Davis SR, Giraldi A, Goldstein I, Goldstein SW, Kim NN, Kingsberg SA, Morgentaler A, Nappi RE, Park K, Stuenkel CA, Traish AM, Vignozzi L. International Society for the Study of Women's Sexual Health Clinical Practice Guideline for the Use of Systemic Testosterone for Hypoactive Sexual Desire Disorder in Women. Journal of Sexual Medicine. 2021;18(5):849-867. https://pubmed.ncbi.nlm.nih.gov/33814355/Annotation: The ISSWSH guideline: testosterone level as a monitoring baseline and not a diagnostic test, informed consent on off-label use, the statement that compounded products cannot be recommended, and the regulatory limitation it names.
  11. 11.Peer-reviewedPilnik S, Belardo A, Marchesan LB, Camero-Lascano A, Acuña-San Martín M, Elizalde-Cremonte A, Ojeda E, Manzur A, Chedraui P. Androgen therapy in midlife and older women: a position statement of the Latin American Association of Gynecological Endocrinology (ALEG). Climacteric. 2025;28(5):529-536. https://pubmed.ncbi.nlm.nih.gov/40919649/Annotation: A 2025 regional position statement limiting testosterone therapy to HSDD confirmed by biopsychosocial evaluation and recommending against compounded bioidentical testosterone.
  12. 12.RegulatoryFDA, FDA issues class-wide labeling changes for testosterone products (Drug Alerts and Statements, 28 February 2025). Accessed 8 November 2026. https://www.fda.gov/drugs/drug-safety-and-availability/fda-issues-class-wide-labeling-changes-testosterone-products
  13. 13.Official sourceDailyMed, AndroGel 1.62% (testosterone gel) prescribing information, revised 07/2025. Accessed 8 November 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f4e8d29b-8707-4d47-e053-2a95a90aecee
  14. 14.RegulatoryFederal Register, Advisory Committee for Reproductive Health Drugs; Notice of Meeting, 69 FR 62902 (28 October 2004). Accessed 8 November 2026. https://www.federalregister.gov/documents/2004/10/28/04-24068/advisory-committee-for-reproductive-health-drugs-notice-of-meeting
  15. 15.Official sourceDailyMed, Addyi (flibanserin) tablets prescribing information, revised 12/2025. Accessed 8 November 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3819daf3-e935-2c53-c527-e1d57922f394
  16. 16.Official sourceDailyMed, Vyleesi (bremelanotide) injection prescribing information, revised 03/2024. Accessed 8 November 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf
  17. 17.Regulatory21 CFR 1308.13, Schedule III (eCFR, current as of 5 November 2026). Accessed 8 November 2026. https://www.ecfr.gov/current/title-21/chapter-II/part-1308/section-1308.13
  18. 18.Peer-reviewedNational Academies of Sciences, Engineering, and Medicine; Jackson LM, Parker RM, Mattison DR, editors. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. National Academies Press (NCBI Bookshelf). 2020. https://pubmed.ncbi.nlm.nih.gov/33048485/Annotation: The scope of the NASEM review, which covered compounded testosterone and assessed the evidence behind marketing claims of safety and effectiveness, cited from its indexed abstract.
  19. 19.RegulatoryFDA, National Academies of Science, Engineering, and Medicine (NASEM) Study on the Clinical Utility of Treating Patients with Compounded "Bioidentical" Hormone Therapy. Accessed 8 November 2026. https://www.fda.gov/drugs/human-drug-compounding/national-academies-science-engineering-and-medicine-nasem-study-clinical-utility-treating-patients

Cite this page

ExaVeyra Sciences Editorial Team. Testosterone in Women: The 2019 Global Consensus. ExaVeyra Sciences; 8 November 2026. Available from: https://exaveyra.com/science/hormones/testosterone-therapy-in-women-consensus. Accessed [date accessed].

Common questions

What is the 2019 Global Consensus Position Statement on testosterone for women?
It is a position statement drafted by an international task force and endorsed by eleven societies, including the Endocrine Society, The North American Menopause Society and the International Menopause Society. It graded the evidence from blinded randomized trials of at least twelve weeks and concluded that the only evidence-based indication for testosterone in women is postmenopausal women diagnosed with hypoactive sexual desire disorder after formal biopsychosocial assessment.
What did the consensus find the evidence does not support?
It found insufficient data for any recommendation in premenopausal women, insufficient evidence for cognitive performance, no effect on general wellbeing or depressed mood, no effect on bone mineral density at twelve months and no significant effect on lean mass, body fat or muscle strength. It stated that there are insufficient data for any other symptom, clinical condition or disease prevention.
Is any testosterone product FDA-approved for women?
No. FDA states that testosterone products are approved only for use in men who lack or have low testosterone in conjunction with an associated medical condition, and the AndroGel 1.62% label states that it is not indicated for use in women. A transdermal testosterone product for surgically menopausal women went before an FDA advisory committee in December 2004 and no approval for women followed.
What safety findings does the consensus report?
At physiological concentrations it reports mild increases in acne and body or facial hair in some women, adverse lipid effects with oral testosterone, no significant short-term lipid effects with nonoral routes, a nonsignificant trend toward deep venous thrombosis, and no data beyond 24 months. Women at high cardiometabolic risk were excluded from the trials, so the findings are not generalizable to them.
What do the guidelines say about compounded testosterone creams for women?
The consensus states that compounded bioidentical testosterone cannot be recommended because of the lack of evidence for efficacy and safety unless an authorized equivalent is unavailable, and that pellets, injections and any preparation producing supraphysiologic concentrations are not recommended. The ISSWSH 2021 guideline states that compounded products cannot be recommended.
Can a blood testosterone level diagnose low desire in women?
The consensus states that no cutoff blood level of any circulating androgen distinguishes women with and without sexual dysfunction, and the ISSWSH guideline states that total testosterone should be used as a monitoring baseline and not to diagnose HSDD. The Endocrine Society guideline reported that endogenous testosterone levels did not predict response.

This page is provided for informational purposes only. It is not medical advice, it is not intended to diagnose, treat, cure, or prevent any disease, and it is not a substitute for the judgment of a licensed practitioner. Consult a healthcare professional before acting on anything stated here. ExaVeyra Sciences is a supplier and takes no part in any diagnosis, treatment decision, or plan of care. These references report what endocrine guidelines, position statements, trials and FDA labeling state about hormone preparations, for professional education, and make no statement about the suitability of any product for any patient. Where this page discusses an FDA-approved product, the approved labeling governs and nothing here modifies it. Compounded medications are a separate product class: they are not FDA-approved finished drug products, they are prepared under section 503A of the Federal Food, Drug, and Cosmetic Act against a prescription for an individual patient, and they are prescription products supplied to licensed practitioners only. Where a controlled substance such as testosterone is prescribed, our 503A pharmacy partner dispenses it under its own DEA registration. The prescribing decision rests with the licensed practitioner. Read the full notice

Reference only. Not legal or medical advice.

The content of these guides is provided for general informational purposes only. It does not constitute legal, medical, or regulatory advice, and does not establish that any particular product or practice is compliant. Regulatory requirements vary by state and depend on the circumstances of each practice. Each practitioner should consult their own legal counsel and the applicable state licensing boards before acting on anything stated here.

Read the full notice