A Study to Evaluate Bleeding Patterns With Three Different Doses of DR-1031 Compared to Seasonale
Completed · Phase 2 · Has a placebo group
Conditions studied: Breakthrough Bleeding
In brief
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 and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary
Key facts
- Study ID
- NCT00394771
- Run by
- Duramed Research
- People needed
- 567
- Starts
- 2006-10-01
- Expected to finish
- 2008-03-01
- Last updated by the study team
- 2013-07-26
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Premenopausal
- Not pregnant or breastfeeding
- Agree to use back-up non-hormonal contraception for study period
You may not qualify if…
- Any contraindication to the use of oral contraceptives
- Pregnancy within the last 3 months
- Smoking >10 cigarettes per day
Where it is running
- Duramed Investigational Site — Huntsville, Alabama, United States
- Duramed Investigational Site — Tucson, Arizona, United States
- Duramed Investigational Site — Little Rock, Arkansas, United States
- Duramed Investigational Site — San Diego, California, United States
- Duramed Investigational Site — San Francisco, California, United States
- Duramed Investigational Site — Santa Ana, California, United States
- Duramed Investigational Site — Vista, California, United States
- Duramed Investigational Site — Pueblo, Colorado, United States
- Duramed Investigational Site — Stratford, Connecticut, United States
- Duramed Investigational Site — DeLand, Florida, United States
- Duramed Investigational Site — Jacksonville, Florida, United States
- Duramed Investigational Site — Melbourne, Florida, United States
- Duramed Investigational Site — Miami, Florida, United States
- Duramed Investigational Site — Tampa, Florida, United States
- Duramed Investigational Site — West Palm Beach, Florida, United States
- Duramed Investigational Site — West Palm Beach, Florida, United States
- Duramed Investigational Site — Alpharetta, Georgia, United States
- Duramed Investigational Site — Douglasville, Georgia, United States
- Duramed Investigational Site — Savannah, Georgia, United States
- Duramed Investigational Site — Boise, Idaho, United States
- Duramed Investigational Site — Meridian, Idaho, United States
- Duramed Investigational Site — Fort Wayne, Indiana, United States
- Duramed Investigational Site — Wichita, Kansas, United States
- Duramed Investigational Site — Baton Rouge, Louisiana, United States
- Duramed Investigational Site — Metairie, Louisiana, United States
Full record on ClinicalTrials.gov
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