A Study to Evaluate the Efficacy and Safety of DR-103 for the Prevention of Pregnancy

Completed · Phase 3

Conditions studied: Pregnancy Prevention

In brief

This is an open-label, single-treatment study. All subjects will receive 12 months of oral contraceptive therapy with DR-103. 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

NCT00996580

Run by

Teva Women's Health

People needed

3597

Starts

2009-10-01

Expected to finish

2011-09-01

Last updated by the study team

2013-06-24

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Sexually active at risk for pregnancy
• Agreement to use study OC therapy as their only method of birth control during the study
• history of regular spontaneous menstrual cycles or withdrawal bleeding episodes
• Others as dictated by FDA-approved protocol

You may not qualify if…

• Any contraindication to the use of oral contraceptives
• Pregnancy or plans to become pregnant in the next 14 months
• Smoker and age ≥ 35 years
• Others as dictated by FDA-approved protocol

Where it is running

• Teva Women's Health Research Investigational Site — Phoenix, Arizona, United States
• Teva Women's Health Research Investigational Site — Phoenix, Arizona, United States
• Teva Women's Health Research Investigational Site — Tucson, Arizona, United States
• Teva Women's Health Research Investigational Site — Little Rock, Arkansas, United States
• Teva Women's Health Research Investigational Site — Anaheim, California, United States
• Teva Women's Health Research Investigational Site — Irvine, California, United States
• Teva Women's Health Research Investigational Site — Los Angeles, California, United States
• Teva Women's Health Research Investigational Site — National City, California, United States
• Teva Women's Health Research Investigational Site — San Diego, California, United States
• Teva Women's Health Research Investigational Site — San Diego, California, United States
• Teva Women's Health Research Investigational Site — San Diego, California, United States
• Teva Women's Health Research Investigational Site — San Francisco, California, United States
• Teva Women's Health Research Investigational Site — Torrance, California, United States
• Teva Women's Health Research Investigational Site — Colorado Springs, Colorado, United States
• Teva Women's Health Research Investigational Site — Pueblo, Colorado, United States
• Teva Women's Health Research Investigational Site — Washington D.C., District of Columbia, United States
• Teva Women's Health Research Investigational Site — Clearwater, Florida, United States
• Teva Women's Health Research Investigational Site — Jacksonville, Florida, United States
• Teva Women's Health Research Investigational Site — Leesburg, Florida, United States
• Teva Women's Health Research Investigational Site — Miami, Florida, United States
• Teva Women's Health Research Investigational Site — Miami, Florida, United States
• Teva Women's Health Research Investigational Site — New Port Richey, Florida, United States
• Teva Women's Health Research Investigational Site — Palm Beach, Florida, United States
• Teva Women's Health Research Investigational Site — St. Petersburg, Florida, United States
• Teva Women's Health Research Investigational Site — Montgomery, Alabama, United States

Full record on ClinicalTrials.gov

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