Open-Label Study to Evaluate the Safety and Efficacy of a Low-Dose 28-Day Oral Contraceptive

Completed · Phase 3

Conditions studied: Contraception

In brief

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, including Pap smear. During the study, all participants will be required to complete a diary.

Key facts

Study ID

NCT00362479

Run by

Duramed Research

People needed

1347

Starts

2006-08-01

Expected to finish

2007-07-01

Last updated by the study team

2013-08-21

Who can join

Age: 18 and older, up to 45. 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 — Mobile, Alabama, United States
• Duramed Investigational Site — Phoenix, Arizona, United States
• Duramed Investigational Site — Phoenix, Arizona, United States
• Duramed Investigational Site — Carmichael, California, United States
• Duramed Investigational Site — Irvine, California, United States
• Duramed Investigational Site — San Diego, California, United States
• Duramed Investigational Site — San Diego, California, United States
• Duramed Investigational Site — San Ramon, California, United States
• Duramed Investigational Site — Colorado Springs, Colorado, United States
• Duramed Investigational Site — Lakewood, Colorado, United States
• Duramed Investigational Site — Wilmington, Delaware, United States
• Duramed Investigational Site — Washington D.C., District of Columbia, United States
• Duramed Investigational Site — Aventura, Florida, United States
• Duramed Investigational Site — Boynton Beach, Florida, United States
• Duramed Investigational Site — Brooksville, Florida, United States
• Duramed Investigational Site — Clearwater, Florida, United States
• Duramed Investigational Site — Coral Gables, Florida, United States
• Duramed Investigational Site — Fort Meyers, Florida, United States
• Duramed Investigational Site — Leesburg, Florida, United States
• Duramed Investigational Site — Longwood, Florida, United States
• Duramed Investigational Site — Miami, Florida, United States
• Duramed Investigational Site — Pinellas Park, Florida, United States
• Duramed Investigational Site — Sarasota, Florida, United States
• Duramed Investigational Site — St. Petersburg, Florida, United States
• Duramed Investigational Site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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