Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose Combination Oral Contraceptive
Completed · Phase 3
Conditions studied: Contraception
In brief
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, including Pap smear. During the study, all participants will be required to complete a diary.
Key facts
- Study ID
- NCT00196326
- Run by
- Duramed Research
- People needed
- 2235
- Starts
- 2005-06-01
- Expected to finish
- 2007-06-01
- Last updated by the study team
- 2016-11-16
Who can join
Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Premenopausal
- Not pregnant or breastfeeding
- Sexually active at risk of pregnancy
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 — Phoenix, Arizona, United States
- Duramed Investigational Site — Phoenix, Arizona, United States
- Duramed Investigational Site — Phoenix, Arizona, United States
- Duramed Investigational Site — Tucson, Arizona, United States
- Duramed Investigational Site — San Diego, California, United States
- Duramed Investigational Site — San Diego, California, United States
- Duramed Investigational Site — Colorado Springs, Colorado, United States
- Duramed Investigational Site — Colorado Springs, Colorado, United States
- Duramed Investigational Site — Denver, Colorado, United States
- Duramed Investigational Site — New London, Connecticut, United States
- Duramed Investigational Site — Coral Cables, Florida, United States
- Duramed Investigational Site — Hollywood, Florida, United States
- Duramed Investigational Site — Jacksonville, Florida, United States
- Duramed Investigational Site — Leesburg, Florida, United States
- Duramed Investigational Site — Miami, Florida, United States
- Duramed Investigational Site — Palm Springs, Florida, United States
- Duramed Investigational Site — Sarasota, Florida, United States
- Duramed Investigational Site — Tampa, Florida, United States
- Duramed Investigational Site — Decatur, Georgia, United States
- Duramed Investigational Site — Douglasville, Georgia, United States
- Duramed Investigational Site — Boise, Idaho, United States
- Duramed Investigational Site — Chicago, Illinois, United States
- Duramed Investigational Site — Shawnee Mission, Kansas, United States
- Duramed Investigational Site — Topeka, Kansas, United States
- Duramed Investigational Site — Huntsville, Alabama, United States
Full record on ClinicalTrials.gov
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