Status:
COMPLETED
A Study to Evaluate Bleeding Patterns With Three Different Doses of DR-1031 Compared to Seasonale
Lead Sponsor:
Duramed Research
Conditions:
Breakthrough Bleeding
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
Brief Summary
This is a 4-arm study to evaluate and compare bleeding patterns between three different doses of DR-1031 oral contraceptive with Seasonale oral contraceptive. Study participants will receive physical ...
Detailed Description
This Phase 2, prospective, multicenter, double-blinded, randomized study is designed to evaluate and compare bleeding patterns in women using one of three different doses of DR-1031 oral contraceptive...
Eligibility Criteria
Inclusion
- Premenopausal
- Not pregnant or breastfeeding
- Agree to use back-up non-hormonal contraception for study period
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 :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
567 Patients enrolled
Trial Details
Trial ID
NCT00394771
Start Date
October 1 2006
End Date
March 1 2008
Last Update
July 26 2013
Active Locations (50)
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1
Duramed Investigational Site
Huntsville, Alabama, United States, 35801
2
Duramed Investigational Site
Tucson, Arizona, United States, 85741
3
Duramed Investigational Site
Little Rock, Arkansas, United States, 72205
4
Duramed Investigational Site
San Diego, California, United States, 92108