NCT01291004

A Study to Evaluate Ovarian Follicular Activity and Hormone Levels for DR-102 Compared to Two 28-Day Oral Contraceptives

A Multicenter, Open-Label Study to Evaluate Ovarian Follicular Activity and Hormone Levels With the Oral Contraceptive Regimen DR-102 Compared to Two 28-day Oral Contraceptive Regimens Containing Different Synthetic Progestins

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 206 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

This study is being conducted to evaluate the impact of a 28-day oral contraceptive compared to two 28-day oral contraceptive regimens containing different synthetic progestins on ovarian follicular activity and hormone levels in healthy women.

Conditions

• Follicle Development
• Ovarian Follicle
• Follicle Count
• Follicle Size
• Oral Contraceptive

Interventions

Type	Name	Description
DRUG	Desogestrel/ethinyl estradiol and ethinyl estradiol	Desogestrel/ethinyl estradiol 0.15/0.02 mg and ethinyl estradiol 0.01 mg tablet
DRUG	28-day drospirenone oral contraceptive	Drospirenone/ethinyl estradiol 0.3/0.02 mg
DRUG	28-day levonorgestrel oral contraceptive	Levonorgestrel/ethinyl estradiol 0.1/0.02 mg

Timeline

• Start date: 2011-01-31
• Primary completion: 2012-03-31
• Completion: 2012-03-31
• First posted: 2011-02-07
• Last updated: 2021-12-08

Locations

2 sites across 1 country: United States