Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of DR-102 for the Prevention of Pregnancy
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
Contraception
Female Contraception
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-102. Study participants will receive physical and gynecological exams, includin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
2858 Patients enrolled
Trial Details
Trial ID
NCT01178125
Start Date
August 1 2010
End Date
January 1 2013
Last Update
November 9 2021
Active Locations (62)
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1
Teva Investigational Site 10007
Montgomery, Alabama, United States
2
Teva Investigational Site 10013
Phoenix, Arizona, United States
3
Teva Investigational Site 10017
Phoenix, Arizona, United States
4
Teva Investigational Site 10032
Little Rock, Arkansas, United States