CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,235 enrolled
Drug / intervention
DR-1011drug
Likely dose
Levonorgestrel 100 μg / ethinyl estradiol 20 μg (one tablet daily for 84 days), followed by ethinyl estradiol 10 μg (one tablet daily for 7 days), repeated in 91-day cyclesAI-extracted
Key inclusion· 3
  • ✓Premenopausal status
  • ✓Sexually active at risk of pregnancy
  • ✓Not pregnant or breastfeeding
Key exclusion· 3
  • ✕Any contraindication to oral contraceptive use
  • ✕Pregnancy within the last 3 months
  • ✕Heavy smoking (>10 cigarettes per day)

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

Search/NCT00196326
NCT00196326Phase 3Completed
CompareCT.gov

A Multicenter, Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose, Combination Oral Contraceptive, Which Utilizes Ethinyl Estradiol During the Seven Day Interval Between Each 84-day Cycle

Duramed Research·interventional·Posted Sep 20, 2005·Updated Nov 16, 2016

In Brief

A Phase 3 clinical trial evaluating DR-1011 for Contraception. Completed, enrolled 2,235 participants across 55 sites.

Detailed Summary

This is an open-label, single treatment study. All subjects will receive one year of oral contraceptive therapy with DR-1011. 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--
ConditionsContraception
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 20, 2005
Enrollment StartJun 1, 2005
Primary CompletionJun 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 20.8 years ago

Interventions

DR-1011drug

Eighty-four orange, embossed tablets, each containing 100 μg levonorgestrel (LNG) / 20 μg ethinyl estradiol (EE) and 7 yellow, embossed tablets, each containing 10 μg of EE. One combination tablet was to be taken each day for 84 days followed by 7 days of EE tablets in 91-day cycles repeated consecutively for approximately one year (four 91-day cycles).