Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of DR-103 for the Prevention of Pregnancy
Lead Sponsor:
Teva Women's Health
Conditions:
Pregnancy Prevention
Eligibility:
FEMALE
18-40 years
Phase:
PHASE3
Brief 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, includin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
3597 Patients enrolled
Trial Details
Trial ID
NCT00996580
Start Date
October 1 2009
End Date
September 1 2011
Last Update
June 24 2013
Active Locations (94)
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1
Teva Women's Health Research Investigational Site
Montgomery, Alabama, United States, 36116
2
Teva Women's Health Research Investigational Site
Phoenix, Arizona, United States, 85015
3
Teva Women's Health Research Investigational Site
Phoenix, Arizona, United States, 85037
4
Teva Women's Health Research Investigational Site
Tucson, Arizona, United States, 85741