Status:
COMPLETED
Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose Combination Oral Contraceptive
Lead Sponsor:
Duramed Research
Conditions:
Contraception
Eligibility:
FEMALE
18-40 years
Phase:
PHASE3
Brief 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, includin...
Eligibility Criteria
Inclusion
- Premenopausal
- Not pregnant or breastfeeding
- Sexually active at risk of pregnancy
Exclusion
- Any contraindication to the use of oral contraceptives
- Pregnancy within the last 3 months
- Smoking \> 10 cigarettes per day
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
2235 Patients enrolled
Trial Details
Trial ID
NCT00196326
Start Date
June 1 2005
End Date
June 1 2007
Last Update
November 16 2016
Active Locations (55)
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1
Duramed Investigational Site
Huntsville, Alabama, United States, 35801
2
Duramed Investigational Site
Phoenix, Arizona, United States, 85013
3
Duramed Investigational Site
Phoenix, Arizona, United States, 85031
4
Duramed Investigational Site
Phoenix, Arizona, United States, 85032