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

A Multinational, Multicenter, Randomized, Open-Label Study to Evaluate the Impact of a 91-Day Extended Cycle Oral Contraceptive Regimen, Compared to Two 28-day Standard Oral Contraceptive Regimens, on Hemostatic Parameters in Healthy Women.

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.

Inclusion Criteria:

• 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 Criteria:

• 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