Last updated: September 12, 2026
Hormone replacement therapy continues to evolve as the Food and Drug Administration hosts a free public workshop on September 17, 2026, to examine testosterone use in menopausal women, a gathering that could shape how this hormone is prescribed to millions of American women in the years ahead. The FDA’s Office of Women’s Health and Center for Drug Evaluation and Research announced the workshop on September 8, 2026, with registration closing September 10 for in-person attendance and public comments accepted through October 19. This marks a significant moment for hormone replacement therapy because testosterone carries no FDA approval for female patients despite widespread off-label prescribing. Women in the Portland, Oregon metro area and surrounding communities like Lake Oswego, Happy Valley, Milwaukie, Beaverton, and West Linn who are researching their menopause treatment options should understand what this federal engagement means for their healthcare choices.
What Is the FDA Workshop on Testosterone for Menopause?
Testosterone use in menopausal women is the focus of an upcoming FDA public workshop. The FDA’s Office of Women’s Health and Center for Drug Evaluation and Research announced on September 8, 2026, that the workshop will take place on September 17, 2026, examining current evidence and knowledge gaps around testosterone prescribing for women experiencing menopause symptoms. Registration for in-person attendance closes September 10, 2026, while the public comment period remains open through October 19, 2026.
When and where is the FDA hosting this workshop?
The FDA workshop on testosterone use in menopausal women is scheduled for September 17, 2026. The agency announced the public meeting through its Office of Women’s Health, making it accessible to healthcare providers, researchers, and interested members of the public who wish to attend or submit written comments. The FDA’s meeting page provides registration information and details for those who wish to participate virtually or in person.
Who can attend or participate in the workshop?
Healthcare providers, researchers, patient advocates, and interested community members can attend or provide input to the FDA workshop. The agency is accepting written public comments through October 19, 2026, allowing individuals who cannot attend the live event to share their perspectives on testosterone use in menopausal women. This open participation reflects the FDA’s commitment to gathering diverse input on an issue affecting many women’s health trajectories.
Why Is the FDA Reviewing Testosterone for Women Now?
The FDA is reviewing testosterone for women because the hormone is widely prescribed off-label to address menopause symptoms despite lacking regulatory approval for female patients. Medical providers have increasingly offered testosterone therapy to help women experiencing low libido, fatigue, mood changes, and other symptoms that accompany the hormonal shifts of menopause. The FDA’s decision to convene a dedicated workshop signals that the agency is actively examining the evidence base and knowledge gaps surrounding this prescribing pattern.
What symptoms does testosterone address in women?
Testosterone therapy in women targets several symptoms associated with hormonal decline during menopause. Women may experience reduced sexual desire, persistent fatigue, difficulty maintaining muscle mass, mood instability, and cognitive changes sometimes described as brain fog. Testosterone addresses these concerns by supporting energy levels, sexual function, mental clarity, and overall sense of well-being. Healthcare providers at clinics like Vip Aesthetics Wellness often hear from patients experiencing these exact challenges.
What knowledge gaps is the FDA trying to fill?
The FDA is working to identify knowledge gaps surrounding testosterone prescribing for women. Key areas include optimal dosing strategies for female patients, long-term safety outcomes, appropriate patient selection criteria, and how testosterone interacts with other hormone replacement approaches. The workshop aims to inform future research priorities and potential regulatory pathways for testosterone products indicated specifically for women.
How Does Testosterone Therapy Fit Into Hormone Replacement Therapy?
Testosterone therapy represents one component within the broader landscape of hormone replacement therapy for women navigating menopause. Hormone replacement therapy encompasses estrogen, progesterone, and testosterone supplementation, each addressing different aspects of hormonal balance. At Vip Aesthetics Wellness, providers develop personalized hormone replacement therapy plans that may include testosterone alongside other hormones depending on each patient’s symptom profile and health history.
What are the different forms of hormone replacement therapy?
Hormone replacement therapy is available in multiple delivery methods to suit different patient preferences and needs. Bioidentical hormone pellet therapy provides sustained hormone release over several months through small pellets inserted under the skin. Other options include topical gels, patches, creams, and oral formulations. Each delivery method offers distinct advantages regarding absorption, convenience, and consistency of dosing.
How do providers approach testosterone dosing for women?
Providers approach testosterone dosing for women with careful attention to the significant differences between male and female hormone requirements. Women typically receive substantially lower doses than men, with treatment individualized based on symptom response and hormone level monitoring. Dr. Zaander’s personalized menopause treatment approach at Vip Aesthetics Wellness emphasizes thorough evaluation and ongoing assessment to support good outcomes while minimizing potential side effects.
What Questions Will the FDA Workshop Address?
The FDA workshop will address the current state of scientific evidence on testosterone use in menopausal women. The workshop scope includes examining available research on safety and efficacy, identifying critical knowledge gaps that warrant further investigation, and discussing future directions for research and potential drug development. This federal engagement reflects growing recognition that women deserve clearer guidance on testosterone therapy options.
What evidence exists on testosterone safety for women?
Research indicates that when properly dosed, testosterone therapy in women is generally well-tolerated, though potential side effects include acne, hair growth changes, and effects on cholesterol levels. The FDA workshop will review available safety data to establish what is known and where additional investigation is needed.
How might this workshop change prescribing guidelines?
Potential changes include developing standardized dosing recommendations, patient selection criteria, and monitoring protocols. If the workshop identifies sufficient evidence, it might also pave the way for FDA-approved testosterone products specifically indicated for menopausal women, legitimizing and guiding what is currently an off-label practice.
What Should Portland-Area Women Know Before Starting Hormone Replacement Therapy?
Women considering hormone replacement therapy should understand the importance of working with qualified medical providers who specialize in hormone health. The landscape of menopause treatment has evolved significantly, and finding a practitioner who takes time to understand each patient’s unique symptoms, health history, and wellness goals makes a meaningful difference in outcomes. Women throughout the Portland metro area, including those in Milwaukie, Lake Oswego, Happy Valley, Beaverton, West Linn, and surrounding communities, have access to specialized hormone therapy providers who can guide them through the decision-making process.
How do I find a qualified hormone therapy provider?
Finding a qualified hormone therapy provider involves looking for healthcare professionals with specific training in hormone health and menopause management. The ideal provider conducts comprehensive evaluations, including hormone level testing, and develops individualized treatment plans rather than applying a one-size-fits-all approach. Bioidentical hormone therapy in Portland represents one option that many women explore when seeking personalized care.
What should I expect during a consultation?
A hormone therapy consultation typically begins with a thorough discussion of symptoms, medical history, and health concerns. Providers may order laboratory testing to assess hormone levels and identify underlying imbalances. From there, the practitioner explains available treatment options, potential benefits, and expected timelines for experiencing results. Patients should feel comfortable asking questions about the provider’s experience and approach to monitoring treatment progress.
Risks, Side Effects and Who Is Not a Candidate
Safety information for testosterone, from the FDA-approved label. Testosterone gels such as AndroGel carry a boxed warning – the FDA’s most serious warning – because the drug can transfer by skin contact and has caused virilization (male sexual characteristics) in children. Injectable testosterone cypionate labels do not carry that boxed warning. Testosterone is contraindicated in men with breast cancer or known or suspected prostate cancer, and in women who are pregnant. Labels state it can raise blood pressure, increasing cardiovascular risk over time, and advise periodic monitoring. FDA-approved label
About compounded and pellet hormone therapy. Compounded “bioidentical” hormone preparations are not FDA approved: the agency does not review them for safety, effectiveness or quality before they are sold. The American College of Obstetricians and Gynecologists advises that compounded bioidentical menopausal hormone therapy should not be prescribed routinely where FDA-approved formulations exist, and that evidence for claims that these preparations are safer or more effective is lacking. FDA-approved bioidentical products, chemically identical to human hormones, do exist. Implanted pellets cannot be removed easily once placed. FDA on the NASEM review of compounded bioidentical hormone therapy
Testosterone therapy carries real risks and potential side effects that every woman should understand before starting treatment. Common side effects may include acne, oily skin, increased body or facial hair growth, and changes in cholesterol levels. Testosterone can affect blood clotting factors and may not be appropriate for women with certain medical histories. Women who are pregnant or breastfeeding should not use testosterone, and those with hormone-sensitive cancers, severe heart disease, or uncontrolled high blood pressure typically require alternative treatment approaches.
Laboratory monitoring is essential during testosterone therapy to track hormone levels and assess for any adverse effects on liver function or blood counts. The FDA has not approved testosterone products for women, meaning all such prescribing is considered off-label. This underscores the importance of working with experienced providers who can navigate the nuances of off-label prescribing responsibly.
Women considering hormone replacement therapy should discuss their complete medical history with a qualified provider, including any personal or family history of breast cancer, ovarian cancer, blood clots, stroke, or cardiovascular disease. Regular follow-up appointments and appropriate screening tests help keep hormone therapy safe and effective over time. Patients are encouraged to report any unusual symptoms promptly and to attend all recommended monitoring appointments.
The decision to pursue hormone therapy involves weighing potential benefits against individual risk factors. For many women, the improvement in quality of life through reduced hot flashes, better sleep, improved mood, and restored sexual satisfaction makes treatment worthwhile when appropriately managed. Working closely with a knowledgeable provider helps hormone replacement therapy serve each patient’s health goals safely and effectively.
What Happens Next for Women Considering Hormone Replacement Therapy Options?
While the regulatory process will take time, women who are experiencing menopause symptoms today do not need to wait for federal action to explore their options. Hormone replacement therapy remains available through qualified providers who can help patients understand the benefits and considerations of testosterone supplementation.
For women throughout the Portland area and surrounding communities including Lake Oswego, Milwaukie, Happy Valley, Beaverton, West Linn, and beyond, specialized hormone therapy services are accessible through providers who prioritize personalized care. Whether you are just beginning to research hormone replacement options or have been considering treatment for some time, scheduling a consultation with experienced practitioners can provide clarity and guidance tailored to your individual needs.
Vip Aesthetics Wellness offers hormone replacement therapy consultations for women seeking to understand their options for managing menopause symptoms. Hormone replacement therapy treatments at Vip Aesthetics Wellness are customized to each patient’s unique physiology and wellness objectives. Women interested in learning more about testosterone therapy, bioidentical hormone options, or other hormone replacement approaches can schedule a consultation to discuss their symptoms and explore personalized treatment strategies with qualified providers.
Frequently Asked Questions
What is the FDA workshop on testosterone for menopause?
The FDA is hosting a free public workshop on September 17, 2026, to examine testosterone use in menopausal women. The FDA’s Office of Women’s Health and Center for Drug Evaluation and Research announced the workshop on September 8, 2026. It will assess current evidence and knowledge gaps around testosterone prescribing for women experiencing menopause symptoms. Registration for in-person attendance closes September 10, while public comments are accepted through October 19, 2026.
When is the FDA hosting its workshop on testosterone and menopause?
The FDA workshop is scheduled for September 17, 2026. Healthcare providers, researchers, patient advocates, and interested community members can attend or submit written comments. The registration deadline for in-person attendance is September 10, 2026, while the public comment period remains open through October 19, 2026, allowing those who cannot attend to share their perspectives on testosterone use in menopausal women.
What symptoms does testosterone therapy address in women?
Testosterone therapy targets symptoms associated with hormonal decline during menopause, including reduced sexual desire, persistent fatigue, difficulty maintaining muscle mass, mood instability, and cognitive changes sometimes described as brain fog. Testosterone addresses these concerns by supporting energy levels, sexual function, mental clarity, and overall sense of well-being.
How is testosterone dosing different for women compared to men?
Women typically receive substantially lower doses of testosterone than men, with treatment individualized based on symptom response and hormone level monitoring. Providers approach dosing with careful attention to the significant differences between male and female hormone requirements. Ongoing assessment ensures optimal outcomes while minimizing potential side effects.
What are the side effects of testosterone therapy for women?
Common side effects of testosterone therapy in women include acne, oily skin, increased body or facial hair growth, and changes in cholesterol levels. Testosterone can affect blood clotting factors. Women who are pregnant or breastfeeding should not use testosterone, and those with hormone-sensitive cancers, severe heart disease, or uncontrolled high blood pressure typically require alternative treatment approaches.
What forms of hormone replacement therapy are available?
Hormone replacement therapy is available in multiple delivery methods to suit different patient preferences. Bioidentical hormone pellet therapy provides sustained hormone release over several months through small pellets inserted under the skin. Other options include topical gels, patches, creams, and oral formulations. Each delivery method offers distinct advantages regarding absorption, convenience, and consistency of dosing.
How do I find a qualified hormone therapy provider?
Finding a qualified hormone therapy provider involves looking for healthcare professionals with specific training in hormone health and menopause management. The ideal provider conducts comprehensive evaluations, including hormone level testing, and develops individualized treatment plans rather than applying a one-size-fits-all approach. Patients should feel comfortable asking about the provider’s experience and approach to monitoring treatment progress.
Sources
- Federal Register
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Testosterone Use in Menopausal Women; Public Workshop; Request for Comments - FDA Public Meeting: Testosterone Use In Menopausal Women – 09/17/2026 | FDA
This article is general information and is not medical advice. Talk to a licensed clinician about your own situation before making a treatment decision.
