Phase 3
N=2,858
A Study to Evaluate the Efficacy and Safety of DR-102 for the Prevention of Pregnancy
Contraception · Female Contraception
Bottom Line
View on ClinicalTrials.gov: NCT01178125 ↗Enrolled (actual)
2,858
Serious AEs
1.7%
Results posted
Dec 2013
Primary outcome: Primary: All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight, Using the 7-Day Rule — 2.43; 2.35; 2.90 pregnancies / 100 woman years exposure
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- DR-102 (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight, Using the 7-Day Rule |
2.43; 2.35; 2.90 | — |
| PRIMARY Typical-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight, Using the 7-Day Rule |
2.68; 2.59; 3.23 | — |
| PRIMARY Compliant-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight, Using the 7-Day Rule |
2.00; 1.79; 3.25 | — |
| SECONDARY All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight |
0.0004; 0.0005; 0; 0.0013; 0.0010; 0.0028 | — |
| SECONDARY Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight |
0; 0; 0; 0.0015; 0.0009; 0.0047 | — |
| SECONDARY Percentage of On-Drug Pregnancies in All Users, by Body Weight Decile Groups Using the 7-Day Rule |
0.40; 2.42; 1.61; 1.28; 4.05; 1.20 | — |
| SECONDARY Percentage of On-Drug Pregnancies in Typical-Use, by Body Weight Decile Groups Using the 7-Day Rule |
0.42; 2.50; 1.63; 1.32; 4.15; 1.25 | — |
| SECONDARY Percentage of On-Drug Pregnancies in Compliant-Use, by Body Weight Decile Groups Using the 7-Day Rule |
0.42; 1.67; 1.23; 0.89; 2.79; 0.84 | — |
| SECONDARY Percentage of On-Drug Pregnancies in All Users, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule |
1.65; 1.68; 1.67; 0.83; 1.25; 2.07 | — |
| SECONDARY Percentage of On-Drug Pregnancies in Typical-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule |
1.70; 1.72; 1.72; 0.85; 1.29; 2.15 | — |
| SECONDARY Percentage of On-Drug Pregnancies in Compliant-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule |
0.86; 1.30; 0.84; 0.89; 0.86; 1.29 | — |
Summary
This is an open-label, single treatment study. All subjects will receive 12 months of oral contraceptive therapy with DR-102. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a daily diary.
Eligibility Criteria
Inclusion Criteria
- Sexually active at risk for pregnancy
- Agreement to use study oral contraceptive therapy as their only method of birth control during the study
- History of regular spontaneous menstrual cycles or withdrawal bleeding episodes
- Others as dictated by protocol
Exclusion Criteria
- Any contraindication to the use of oral contraceptives
- Pregnancy or plans to become pregnant in the next 14 months
- Smoker and age greater than or equal to 35 years
- Others as dictated by protocol
Data sourced from ClinicalTrials.gov (NCT01178125). 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.