NCT00891228

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

A Multicenter, Randomized, Double-Blind Comparator Trial of the Safety and Sperm and Gonadotropin Suppression Resulting From Combined Use of Nestorone® Gel (0, 8 or 12 mg NES) and Testosterone Gel (10 g) Compared With Testosterone Gel in Normal Men

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Premier Research · Academic / Other
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

To determine the number of men who have suppression of sperm production when using a daily regimen of Nestorone® Gel (0, 8 or 12 mg) and Testosterone Gel applied transdermally.

Conditions

• Contraception

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-05-01
• Primary completion: 2010-05-01
• Completion: 2011-11-01
• First posted: 2009-05-01
• Last updated: 2018-05-24
• Results posted: 2018-05-24

Locations

2 sites across 1 country: United States