Phase 3
N=2,235
Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose Combination Oral Contraceptive
Contraception
Bottom Line
View on ClinicalTrials.gov: NCT00196326 ↗Enrolled (actual)
2,235
Serious AEs
1.6%
Results posted
Apr 2009
Primary outcome: Primary: Annualized Pregnancy Rate (Pearl Index) For 91-Day Cycles by Cohort Using up to 14 Days Post-Last Combination Dose When Defining "On Drug" Pregnancy — 2.44; 2.42; 1.77 pregnancies per 100 woman years exposure
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- DR-1011 (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Duramed Research
- Primary completion
- Jun 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Annualized Pregnancy Rate (Pearl Index) For 91-Day Cycles by Cohort Using up to 14 Days Post-Last Combination Dose When Defining "On Drug" Pregnancy |
2.44; 2.42; 1.77 | — |
| PRIMARY Annualized Pregnancy Rate (Pearl Index) For 91-Day Cycles by Cohort Using up to 7 Days Post-Last Combination Dose When Defining "On Drug" Pregnancy |
2.15; 2.12; 1.77 | — |
| SECONDARY Participants With Treatment-Emergent Adverse Events |
1742 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Premenopausal
- Not pregnant or breastfeeding
- Sexually active at risk of pregnancy
Exclusion Criteria
- Any contraindication to the use of oral contraceptives
- Pregnancy within the last 3 months
- Smoking > 10 cigarettes per day
Data sourced from ClinicalTrials.gov (NCT00196326). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.