Status:
COMPLETED
Open-Label Study to Evaluate the Safety and Efficacy of a Low-Dose 28-Day Oral Contraceptive
Lead Sponsor:
Duramed Research
Conditions:
Contraception
Eligibility:
FEMALE
18-45 years
Phase:
PHASE3
Brief Summary
This is an open-label, single treatment study. All subjects will receive 6 months of oral contraceptive therapy with DR-1021. Study participants will receive physical and gynecological exams, includin...
Detailed Description
The overall study duration for each patient will be approximately 8 months, which includes a screening period of approximately 4 weeks; a treatment period of approximately six months (six,28-day cycle...
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 :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
1347 Patients enrolled
Trial Details
Trial ID
NCT00362479
Start Date
August 1 2006
End Date
July 1 2007
Last Update
August 21 2013
Active Locations (85)
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1
Duramed Investigational Site
Huntsville, Alabama, United States, 35801
2
Duramed Investigational Site
Mobile, Alabama, United States, 36608
3
Duramed Investigational Site
Phoenix, Arizona, United States, 85015
4
Duramed Investigational Site
Phoenix, Arizona, United States, 85031