Male Contraceptive Gel for Birth Control

Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Health Decisions

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing a gel that men can use to prevent pregnancy. The study involves couples, with a focus on the male partner applying the gel. The gel works by lowering sperm count, making it less likely for the female partner to get pregnant.

Eligibility Criteria

This trial is for healthy men aged 18-50, with a BMI under 33, in stable relationships, and not seeking fertility within the next two years. Participants must have normal sperm counts and testosterone levels, no history of hormone treatments in the past six months, and agree to use contraception initially.

Inclusion Criteria

I am a man in a stable relationship for over a year and have normal reproductive health.

My recent health checks and lab tests show I am in good health.

I am a healthy woman aged 18-34, with regular periods, a uterus, and at least one ovary.

I am a man aged 18-50, with a BMI under 33, and haven't used androgens in the last 6 months.

Exclusion Criteria

I am a male who hasn't been in a drug trial in the last 30 days.

I am not pregnant, breastfeeding, planning to become pregnant, or have a current alcohol or drug abuse issue.

Treatment Details

The study tests a daily gel combining Nestorone® (NES) and Testosterone (T) as a form of male birth control. The goal is to develop an effective contraceptive method for men by applying this gel regularly.

1Treatment groups

Experimental Treatment

Group I: Nestorone (NES) + testosterone (T) combined gelExperimental Treatment1 Intervention

A combination Gel with Nestorone® (NES) and Testosterone (T) applied transdermally (NES/T gel). The amount of gel to be applied daily will be approximately 5 mL in volume (2.5 mL to each shoulder and upper arm per day).