At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 61 enrolled
Drug / intervention
DR-1021 +2 moredrug
Likely dose
DR-1021 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.
A Prospective, Multicenter, Randomized, Double-Blind Study to Evaluate Hormone Patterns and Ovarian Follicular Activity With the Oral Contraceptive Regimen DR-1021
Teva Branded Pharmaceutical Products R&D, Inc.·interventional·Posted Oct 16, 2007·Updated Nov 18, 2021
In Brief
A Phase 3 clinical trial evaluating DR-1021, Mircette®, and 1 other intervention for Healthy. Completed, enrolled 61 participants across 4 sites.
Detailed Summary
This is a multi-center study to evaluate hormone levels with the oral contraceptive regimen DR-1021.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 2007
Enrollment StartOct 2007
Primary CompletionMar 2008
TodayJul 2026
First PostedOct 16, 2007
Enrollment StartOct 31, 2007
Primary CompletionMar 31, 2008
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 18.7 years ago
Interventions
DR-1021drug
Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus seven 10 μg EE tablets.
Mircette®drug
Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus two placebo tablets plus five 10 μg EE tablets.
Kariva®drug
Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus two placebo tablets plus five 10 μg EE tablets.