NCT01388491

A Multinational Study to Evaluate the Effects of a 28-Day Oral Contraceptive on Hemostatic Parameters in Healthy Women

A Multinational, Multicenter, Randomized, Open-Label Study to Evaluate the Impact of DR-102 Compared to a 28-day Standard Oral Contraceptive Regimen, on Hemosatic Parameters in Healthy Women

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 293 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This study is being conducted to evaluate the impact of DR-102, a 28-day oral contraceptive compared to a standard 28-day oral contraceptive regimen on hemostatic parameters in healthy women.

Conditions

• Hemostasis
• Oral Contraceptive

Interventions

Type	Name	Description
DRUG	desogestrel/ethinyl estradiol and ethinyl estradiol
DRUG	desogestrel/ethinyl estradiol

Timeline

• Start date: 2011-10-31
• Primary completion: 2012-09-30
• Completion: 2012-09-30
• First posted: 2011-07-06
• Last updated: 2021-12-06
• Results posted: 2013-11-27

Locations

27 sites across 4 countries: Germany, Israel, Italy, Spain