A Multicenter Study to Evaluate the Effects of a 91-Day Extended Cycle Oral Contraceptive on Hemostatic Parameters in Healthy Women

Completed · Phase 2

Conditions studied: Hemostasis, Oral Contraceptive

In brief

This study is being conducted to evaluate the impact of a 91-day extended cycle oral contraceptive compared to two 28-day oral contraceptive regimens on hemostatic parameters in healthy women.

Key facts

Study ID

NCT01252186

Run by

Teva Women's Health

People needed

265

Starts

2010-11-01

Expected to finish

2011-12-01

Last updated by the study team

2015-03-13

Who can join

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

You may qualify if…

• Premenopausal, non-pregnant, non-lactating women age 18-40 years old
• Body Mass Index (BMI) ≥18 kg/m² and <30 kg/m²
• Regular spontaneous menstrual cycle
• Others as dictated by FDA-approved protocol

You may not qualify if…

• Any condition which contraindicates the use of combination oral contraceptives
• Any history of, or active, deep vein thrombosis, pulmonary embolism, or arterial thromboembolic disease within one year of screening
• Any known genetic component for thrombophilia including Factor V Leiden mutation, prothrombin mutation, protein C deficiency, protein S deficience, or antithrombin III deficiency
• Others as dictated by FDA-approved protocol

Where it is running

• Teva Investigational Site — San Diego, California, United States
• Teva Investigational Site — San Diego, California, United States
• Teva Investigational Site — San Diego, California, United States
• Teva Investigational Site — Washington D.C., District of Columbia, United States
• Teva Investigational Site — Miami, Florida, United States
• Teva Investigational Site — West Palm Beach, Florida, United States
• Teva Investigational Site — Sandy Springs, Georgia, United States
• Teva Investigational Site — Edison, New Jersey, United States
• Teva Investigational Site — Plainsboro, New Jersey, United States
• Teva Investigational Site — Albuquerque, New Mexico, United States
• Teva Investigational Site — Port Jefferson, New York, United States
• Teva Investigational Site — Rochester, New York, United States
• Teva Investigational Site — Winston-Salem, North Carolina, United States
• Teva Investigational Site — Philadelphia, Pennsylvania, United States
• Teva Investigational Site — Pittsburgh, Pennsylvania, United States
• Teva Investigational Site — Uniontown, Pennsylvania, United States
• Teva Investigational Site — Dallas, Texas, United States
• Teva Investigational Site — Houston, Texas, United States
• Teva Investigational Site — San Antonio, Texas, United States
• Teva Investigational Site — Richmond, Virginia, United States
• Teva Investigational Site — Seattle, Washington, United States
• Teva Investigational Site — Cagliari, Italy
• Teva Investigational Site — Modena, Italy
• Teva Investigational Site — Pavia, Italy

Full record on ClinicalTrials.gov

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