On September 17, the U.S. Food and Drug Administration's Office of Women's Health and Center for Drug Evaluation and Research will convene a public workshop on testosterone use in menopausal women. The agency's public docket, FDA-2026-N-5479, is open for comment through 11:59 p.m. Eastern on October 19, 2026.

Sign this petition, and we will show you how to file your own comment with the FDA. A signature shows support. A comment in the docket becomes part of the official record the agency is required to consider.

Here is the gap. There is no FDA-approved testosterone formulation designed for women in the United States. Testosterone is a hormone women produce across their entire lives, and its role in women's health has been studied for decades. But that research has been narrow, the standards for diagnosis and measurement remain unsettled, and no company has been given a clear public roadmap to bring a women-specific product through FDA review.

So women are left in the middle. Clinicians work without the guidance they need. Patients navigate testing, dosing, and monitoring inside a system that was not built for them. The questions that matter most are still open: how should women be studied, how should this be diagnosed and measured, which outcomes count, and what evidence is needed to establish long-term safety.

Those are answerable questions. The workshop on September 17 is where the answering starts.

Transparency. The Testosterone Project is an independently governed nonprofit overseen by an independent Board of Directors. Our operating funding comes from a single private donor, Shalin Shah, and that relationship is fully disclosed on our transparency page along with our conflict-of-interest and recusal policies. TTP does not receive funding from, or make payments to, any pharmaceutical company. Our advocacy positions are set by our independent board and our Medical Advisory Board, not by any funder. Read the full disclosure here: [transparency page link to be inserted after approval].

The Testosterone Project supports rigorous diagnosis, medically supervised care, and evidence-based policy. We are not asking the FDA to lower its standards, endorse any product or company, or recommend testosterone for every woman. We are asking the agency to make the pathway visible, scientifically credible, and responsive to the women whose health needs have too often been treated as an afterthought.

What we are asking the FDA to do

1. Recognize the condition. Establish testosterone deficiency in women as a medical condition through the FDA's indication and labeling framework, so that diagnosis, treatment, and coverage have a foundation to stand on.

2. Publish the roadmap. Explain publicly what evidence a women-specific testosterone product would need to reach review, including standards for diagnosis, measurement, effectiveness, dosing, monitoring, and long-term safety.

3. Study what women need. Ensure the research ahead includes menopausal women and measures the outcomes that are clinically meaningful to their health and their daily lives.

4. Weigh what patients and clinicians say. Give the experience submitted to Docket FDA-2026-N-5479 real weight in the work that follows this workshop, while keeping personal experience distinct from clinical evidence.

Women should not have to wait indefinitely for the research and regulatory attention their health deserves. Add your name, then add your comment.