NCT00796133

A Phase 2, Dose-finding, Cross-over Study to Evaluate the Effect of a NES/E2 Transdermal Gel Delivery on Ovulation Suppression in Normal Ovulating Women

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Population Council · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 2, dose-finding, cross-over study for the purposes of evaluating the effect of a NES/E2 transdermal gel delivery on ovulation suppression in normal ovulating women.

Conditions

• Ovulation

Interventions

Type	Name	Description
DRUG	NES/E2 gel	Lowest effective dose of 3 formulations of the NES/E2 gel to ensure ovulation suppression (P\<10nmol/L) in 90-95% of the cycles. The high dose will deliver 4.5mg of NES; the medium dose will deliver 3mg of NES, and a low dose of 1.5mg of NES. Based on a 10% absorption rate, 450 µg/d, 300 µg/d and 150 µg/d will be absorbed respectively. The doses of Estradiol will also be tailored to the 3 formulations.

Timeline

• Start date: 2008-11-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2008-11-24
• Last updated: 2015-04-17

Locations

3 sites across 3 countries: United States, Chile, Dominican Republic