Phase 3 N=3,597 Prevention

A Study to Evaluate the Efficacy and Safety of DR-103 for the Prevention of Pregnancy

Pregnancy Prevention

Bottom Line

View on ClinicalTrials.gov: NCT00996580 ↗

Enrolled (actual)

3,597

Serious AEs

1.6%

Results posted

Jun 2013

Primary outcome: Primary: All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight — 2.82; 2.46; 4.54 pregnancies / 100 woman years exposure

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: DR-103 (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Teva Women's Health
Primary completion: Sep 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight	2.82; 2.46; 4.54	—
PRIMARY Typical-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight	3.25; 2.83; 5.32	—
PRIMARY Compliant-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight	3.71; 3.23; 6.04	—
PRIMARY All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight	2.74; 2.40; 4.42	—
PRIMARY Typical-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight	2.92; 2.55; 4.72	—
PRIMARY Compliant-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight	3.07; 2.68; 4.94	—
PRIMARY Summary of Participants With Treatment-emergent Adverse Events	2605; 1086; 58; 463	—
SECONDARY All Users Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight	0.0074; 0.0060; 0.0139; 0.0134; 0.0114; 0.0231	—
SECONDARY Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight	0.0080; 0.0062; 0.0164; 0.0134; 0.0116; 0.0215	—

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.

Eligibility Criteria

Inclusion Criteria

Sexually active at risk for pregnancy
Agreement to use study OC 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 FDA-approved 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 ≥ 35 years
Others as dictated by FDA-approved protocol

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00996580). 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.