# CCTN- CONTRACEPTIVE CLINICAL TRIALS NETWORK - MALE SITES - NESTORONE AND TESTOSTERONE GEL

> **NIH NIH N01** · UNIVERSITY OF WASHINGTON · 2022 · $1,186,405

## Abstract

Nestorone® gel (progestogen) in addition to testosterone (T) gel (androgen), both applied
transdermally, has been shown to suppress gonadotropins and sperm production. Preliminary
results from these studies indicate that a dose of 8 mg of Nestorone® gel is required in order to
suppress gonadotropins sufficiently to a level that inhibits spermatogenesis. There are very few
contraceptive options available to men. Studies indicate that men would use a safe and reversible
method of contraception if one were available to them. One promising regimen involves a
method of delivering androgen plus progestogen in order to suppress sperm production. The goal
of the Task Order is to conduct a clinical trial to test whether Nestorone® gel (progestogen) and
testosterone (T) gel (androgen), both applied transdermally, will be effective for contraception in
couples who are willing to use the method as their primary method of contraception.
The Eunice Kennedy Shriver National Institute of Child Health and Human Development
(NICHD) has a mission to develop safe and effective contraceptives for both men and women.
Many women cannot use hormonal contraception and rely on their male partner to protect them
from pregnancy. Current methods available for men are limited to vasectomy and condoms.
Development of effective male contraceptive regimens remains a challenge for the field. In a
clinical trial conducted in the NICHD Contraceptive Clinical Trials Network (CCTN),
Nestorone® gel (progestogen) and testosterone (T) gel (androgen), both applied transdermally,
was effective in suppressing gonadotropins and inhibiting spermatogenesis. The proposed study
will be conducted in men in order to evaluate the safety and contraceptive efficacy of this
regimen in couples who wish to avoid pregnancy and are willing to use the method as their
primary method of birth control.

## Key facts

- **NIH application ID:** 10658780
- **Project number:** 275201300025I-P00006-27500006-1
- **Recipient organization:** UNIVERSITY OF WASHINGTON
- **Principal Investigator:** WILLIAM BREMNER
- **Activity code:** N01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $1,186,405
- **Award type:** —
- **Project period:** 2015-09-15 → 2023-09-14

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10658780

## Citation

> US National Institutes of Health, RePORTER application 10658780, CCTN- CONTRACEPTIVE CLINICAL TRIALS NETWORK - MALE SITES - NESTORONE AND TESTOSTERONE GEL (275201300025I-P00006-27500006-1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10658780. Licensed CC0.

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