NCT03452111

Study of Daily Application of Nestorone® (NES) and Testosterone (T) Combination Gel for Male Contraception

Clinical Evaluation of Daily Application of Nestorone® (NES) and Testosterone (T) Combination Gel for Male Contraception

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 420 (actual)
• Sponsor: Premier Research · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The long term objective is to develop a gel to be used as a male contraceptive.

Detailed description

This is a prospective, phase IIb, open label, single arm, multicenter study. The study protocol consists of a screening phase lasting 4 to 8 weeks, a suppression phase estimated up to 20 weeks, a 52-week maintenance/efficacy phase, and a 24-week (estimated) recovery phase. The study will involve approximately 420 couples recruited throughout the CCTN that meet eligibility criteria. Approximately fifteen sites propose to enroll up to 420 couples (about 30 to 60 couples per site) with a goal of obtaining 200 couples completing the contraceptive efficacy phase of the study. The study has four phases (screening phase, suppression phase, efficacy phase and recovery phase) with monthly visits to provide the male participants with the NES/T gel, to encourage adherence, to monitor for possible side effects, and to quantify semen parameters. The female partner will be contacted monthly and come in for a visit every three months. Male subjects will be treated and followed as outpatients, along with their participating female partner.

Conditions

• Healthy
• Men
• Male Contraception

Interventions

Type	Name	Description
DRUG	Nestorone + Testosterone Combination Gel	The combined gel is a transdermal treatment that will be applied daily for 52 weeks to a male subject's arms and shoulders. The formulation will be a hydro alcoholic gel. About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume.

Timeline

• Start date: 2018-10-25
• Primary completion: 2024-09-06
• Completion: 2024-09-06
• First posted: 2018-03-02
• Last updated: 2025-02-18

Locations

17 sites across 7 countries: United States, Chile, Italy, Kenya, Sweden, United Kingdom, Zimbabwe

Regulatory

• FDA-regulated drug study