Why is there no FDA-approved testosterone product for women in the U.S.?

An FDA panel voted against authorizing the first testosterone patch for women in 2004 due to insufficient long-term safety data, and no product has been approved since.

What benefits are women seeking from testosterone therapy?

Women are increasingly seeking testosterone for benefits beyond libido, including improved energy, mood, and overall vitality.

What are the challenges with female testosterone therapy today?

The lack of FDA-approved formulations and clear dosing guidelines creates a complex and unregulated market, leading to potential risks of improper management and side effects.

Home / Health / The Wild West of Female Testosterone Therapy

The Wild West of Female Testosterone Therapy

27 Jan

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Summary

FDA-approved testosterone for women has been unavailable since 2004.
Women are increasingly seeking off-label testosterone for energy and mood.
Navigating female testosterone therapy involves risks and an unregulated market.

A 2004 FDA panel unanimously voted against authorizing Procter & Gamble's testosterone patch Intrinsa for women, citing insufficient long-term safety data. This decision left a void for decades, with no testosterone products approved for female use in the U.S. In recent years, however, there's a growing interest among Gen X and millennial women in testosterone, not just for libido but for overall vitality, claiming benefits like increased energy and mental clarity.

This resurgence has led to a complex and often unregulated landscape, dubbed the 'Wild West' of female testosterone therapy. While some medical practitioners are cautiously exploring its use, many women are navigating this space through compounding pharmacies and online clinics. The lack of FDA-approved formulations and clear dosing guidelines creates challenges, with risks of improper management and potential side effects becoming a significant concern for patients and experts alike.