NCT01252186

A Multicenter Study to Evaluate the Effects of a 91-Day Extended Cycle Oral Contraceptive on Hemostatic Parameters in Healthy Women

A Multinational, Multicenter, Randomized, Open-Label Study to Evaluate the Impact of a 91-Day Extended Cycle Oral Contraceptive Regimen, Compared to Two 28-day Standard Oral Contraceptive Regimens, on Hemostatic Parameters in Healthy Women.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 265 (actual)
• Sponsor: Teva Women's Health · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This study is being conducted to evaluate the impact of a 91-day extended cycle oral contraceptive compared to two 28-day oral contraceptive regimens on hemostatic parameters in healthy women.

Conditions

• Hemostasis
• Oral Contraceptive

Interventions

Type	Name	Description
DRUG	91-day Levonorgestrel Oral Contraceptive	91-day treatment consisting of 84 blue combination tablets containing 150 µg LNG/30 µg EE and 7 yellow tablets containing 10 µg EE.
DRUG	28-day Levonorgestrel Oral Contraceptive	21 combination tablets containing 150 µg LNG/30 µg EE.
DRUG	28-day Desogestrel Oral Contraceptive	21 combination tablets containing 150 µg DSG/30 µg EE.

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2010-12-02
• Last updated: 2015-03-13
• Results posted: 2015-03-13

Locations

24 sites across 2 countries: United States, Italy