A Pivotal Moment for Testosterone and Men’s Health

The FDA has announced important changes to testosterone labeling following an Expert Panel on Testosterone that took place in December 2025.  The FDA has proposed new language regarding three items:

1. Prostate cancer;
2. Urinary symptoms related to prostate enlargement; and
3. Restriction of use for men with “age-related hypogonadism.”

Specifically, the FDA has proposed removing a contraindication to use of testosterone in men with “known or suspected” prostate cancer, replacing this with a contraindication in metastatic prostate cancer only. It also proposes removing language that warned that testosterone use may increase the risk of developing prostate cancer, and that it may worsen urination symptoms due to enlargement of the prostate. 

In 2015 the FDA inserted a new restriction of use for testosterone therapy in men with what it called age-related hypogonadism, asserting that there was inadequate evidence to determine safety or efficacy in this population. The FDA proposes removing this restriction of use entirely. 

These changes follow a remarkable FDA Expert Panel on Testosterone that took place December 10, 2025, at its headquarters in Silver Spring, MD, co-moderated by Mohit Khera, MD, and with several Androgen Society members participating.   At that meeting, experts presented evidence accumulated over the last two decades, including three large randomized controlled trials, and offered a set of recommendations to the FDA to bring the testosterone label into alignment with modern evidence. 

The Androgen Society applauds the FDA’s efforts to update the testosterone label. These changes will help clinicians and patients, and represent an important step forward for Men’s Health.

The Androgen Society is the premier international organization dedicated to testosterone research, education, and clinical expertise. We are proud that Androgen Society members have been among the voices contributing to this body of evidence — through research, consensus development, and direct engagement with regulatory bodies.

https://www.reuters.com/business/healthcare-pharmaceuticals/us-health-department-proposes-testosterone-therapy-label-updates-2026-06-18/

Groundbreaking FDA Presentation Marks Historic Moment for Testosterone Therapy

On December 10, 2025, the Androgen Society made history as three of the field's most distinguished leaders—Dr. Mohit Khera, Dr. Marty Miner, and Dr. Abe Morgentaler—participated in a groundbreaking FDA panel that could fundamentally transform testosterone therapy access and patient care.

This pivotal panel addressed critical barriers that have long hindered optimal patient treatment, with key recommendations presented to the FDA:

Panel Recommendations:

• Eliminate the “age-related” restriction – Many medical conditions are “age-related” in that they become more prevalent with aging, including hypertension, heart disease, and most adult cancers.  These conditions are treated to improve health. The same should be true for testosterone deficiency. 
• Remove testosterone from the list of controlled substances – No other hormone is controlled. This step will reduce barriers to testosterone therapy access
• Raise treatment threshold to 350 ng/dL – Allow therapy initiation at this level when accompanied by clinical signs and symptoms
• Remove prostate cancer warnings from labeling – Reflecting current evidence and eliminating outdated concerns that prevent appropriate care

This event represents a watershed moment in our field's efforts to advance evidence-based care and remove regulatory obstacles that have prevented countless men from accessing appropriate treatment.

The Androgen Society remains committed to advocating for policies that prioritize patient health and reflect the latest scientific evidence in men’s health. 

April/May Newsletter Now Available

The Androgen Society is pleased to announce the release of our April/May 2026 Newsletter. This issue features a comprehensive Letter from the President, in-depth research summaries curated by Dr. Abdul Traish, updates on our 2026 Annual Meeting, 2026 Award winners, and webinar updates.

Thank you Androgen 2025 Faculty!

Welcome to the Androgen Society!

The Androgen Society is the first professional medical society dedicated entirely to testosterone deficiency (hypogonadism) and its treatment!

The Androgen Society brings together clinicians and investigators from all disciplines to share the latest research information together with clinical expertise.

The mission of the Androgen Society is to promote excellence in research, education, and clinical practice regarding testosterone deficiency and its treatment. Our vision is to provide a home for all the various disciplines involved with testosterone, including endocrinology, urology, sexual medicine, andrology, general medicine, epidemiology, and cardiology.

By sharing knowledge and ideas, we hope to propel the field forward, for the benefit of our patients, public health, and science.

We invite you to join the Androgen Society today!

To join the Androgen Society, please complete our online membership application.