Petition to the U.S. Food and Drug Administration (FDA)

Expand Access to FDA-Approved Low-Dose Testosterone Therapy for Women

To the Commissioner of the U.S. Food and Drug Administration:

We, the undersigned, respectfully urge the U.S. Food and Drug Administration (FDA) to prioritize and facilitate the development, review, and approval of FDA-regulated, low-dose testosterone products specifically formulated for women.

Millions of women experience symptoms associated with low testosterone levels during menopause, surgical menopause, or other medical conditions. For some women, these symptoms may include a significant loss of sexual desire, reduced energy, decreased well-being, and diminished quality of life. Clinical guidelines from several professional organizations recognize that testosterone therapy may be appropriate for carefully selected women, particularly those diagnosed with hypoactive sexual desire disorder (HSDD).

Despite this recognized medical need, women in the United States currently have no FDA-approved testosterone product specifically designed for female dosing. As a result, many patients and physicians must rely on compounded testosterone formulations or attempt to adjust products manufactured for men. This creates challenges including:

Inconsistent availability of standardized dosing specifically designed for women.
Limited access to FDA-reviewed products that have undergone rigorous manufacturing oversight.
Difficulty achieving precise, low-dose treatment appropriate for female physiology.
Unequal access compared with patients in other countries where female testosterone products are available.
We believe women deserve the same commitment to safe, effective, evidence-based hormone therapies that are available for many other medical conditions.

We respectfully ask the FDA to:

Prioritize the review of applications for testosterone products specifically developed for women.
Encourage pharmaceutical manufacturers to develop standardized, low-dose testosterone therapies for female patients.
Support additional clinical research evaluating the safety and effectiveness of testosterone therapy in women.
Work collaboratively with medical societies, researchers, patient advocacy groups, and manufacturers to address this important unmet medical need.
Ensure that women have access to FDA-approved testosterone products with consistent manufacturing standards, reliable dosing, and comprehensive safety information.
This petition is not a request to weaken FDA safety standards. Rather, it is a request to expand safe, evidence-based treatment options through the rigorous FDA approval process.

Women should not be left with limited choices simply because no FDA-approved product currently exists to meet their medical needs. Patients and their healthcare providers deserve access to therapies that have been specifically studied, manufactured, and labeled for women.

We respectfully ask the FDA to recognize this longstanding gap in women’s healthcare and work toward making FDA-approved low-dose testosterone therapy available for those who may benefit under the guidance of qualified healthcare professionals.

Signed,

The Undersigned Supporters of Women’s Health

The FDA cannot approve a drug unless a manufacturer submits an application.

The FDA Commissioner

The U.S. Department of Health and Human Services

Members of Congress who serve on health-related committees

National organizations focused on menopause and women’s health