CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 3,597 enrolled
Drug / intervention
DR-103drug
Likely dose
DR-103 20 mcgfrom 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/NCT00996580
NCT00996580Phase 3Completed
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A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of a Combination Oral Contraceptive Regimen (DR-103) for the Prevention of Pregnancy in Women

Teva Women's Health·interventional·Posted Oct 16, 2009·Updated Jun 24, 2013

In Brief

A Phase 3 clinical trial evaluating DR-103 for Pregnancy Prevention. Completed, enrolled 3,597 participants across 94 sites.

Detailed Summary

This is an open-label, single-treatment study. All subjects will receive 12 months of oral contraceptive therapy with DR-103. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPregnancy Prevention
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 16, 2009
Enrollment StartOct 1, 2009
Primary CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 16.7 years ago

Interventions

DR-103drug

One tablet daily. Four 91-day cycles of the DR-103 regimen: 42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by; 21 days combination therapy of 25 mcg EE/150 mcg LNG followed by; 21 days combination therapy of 30 mcg EE/150 mcg LNG followed by; 7 days of 10 mcg EE.