Study of the Safety, and Sperm and Gonadotropin Suppression of a Contraceptive Gel in Normal Men

PHASE1CompletedINTERVENTIONAL
Enrollment

99

Participants

Timeline

Start Date

May 31, 2009

Primary Completion Date

May 31, 2010

Study Completion Date

November 30, 2011

Conditions
Contraception
Interventions
DRUG

Testosterone

Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.

DRUG

Nestorone®

Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg Nestorone® mL gel) by pressing two times with 2 mL dispenser head.

DRUG

Nestorone®

Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head.

DRUG

Nestorone®

Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head.

Trial Locations (2)

90502

Los Angeles Biomedical Research Institute at Harbor-UCLA, Torrance

98195

University of Washington, Seattle

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Population Council

OTHER

collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

Premier Research

OTHER