CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 265 enrolled
Drug / intervention
91-day Levonorgestrel Oral Contraceptive +2 moredrug
Likely dose
91-day Levonorgestrel Oral Contraceptive 150 µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01252186
NCT01252186Phase 2Completed
CompareCT.gov

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.

Teva Women's Health·interventional·Posted Dec 2, 2010·Updated Mar 13, 2015

In Brief

A Phase 2 clinical trial evaluating 91-day Levonorgestrel Oral Contraceptive, 28-day Levonorgestrel Oral Contraceptive, and 1 other intervention for Hemostasis and Oral Contraceptive. Completed, enrolled 265 participants across 24 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemostasis, Oral Contraceptive
CountriesItaly, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 2, 2010
Enrollment StartNov 1, 2010
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 15.6 years ago

Interventions

91-day Levonorgestrel Oral Contraceptivedrug

91-day treatment consisting of 84 blue combination tablets containing 150 µg LNG/30 µg EE and 7 yellow tablets containing 10 µg EE.

28-day Levonorgestrel Oral Contraceptivedrug

21 combination tablets containing 150 µg LNG/30 µg EE.

28-day Desogestrel Oral Contraceptivedrug

21 combination tablets containing 150 µg DSG/30 µg EE.