Status:
COMPLETED
A Multicenter Study to Evaluate the Effects of a 91-Day Extended Cycle Oral Contraceptive on Hemostatic Parameters in Healthy Women
Lead Sponsor:
Teva Women's Health
Conditions:
Hemostasis
Oral Contraceptive
Eligibility:
FEMALE
18-40 years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
265 Patients enrolled
Trial Details
Trial ID
NCT01252186
Start Date
November 1 2010
End Date
December 1 2011
Last Update
March 13 2015
Active Locations (24)
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1
Teva Investigational Site
San Diego, California, United States, 92103
2
Teva Investigational Site
San Diego, California, United States, 92108
3
Teva Investigational Site
San Diego, California, United States, 92123
4
Teva Investigational Site
Washington D.C., District of Columbia, United States, 20036