Efficacy and Safety of Oral NOMAC-E2 in Indian Women (P07057/MK-8175A-017)

An Open-label, Multi-center Trial to Evaluate the Contraceptive Efficacy, Safety and Acceptability of a Monophasic Combined Oral Contraceptive (COC) Containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) in Indian Women. Protocol MK-8175A-017-00

This study will investigate the efficacy and safety of the monophasic

combined oral contraceptive (COC) containing 2.5 mg NOMAC and 1.5 mg E2 in

healthy fertile Indian women.

Inclusion Criteria:

• Sexually active and at risk for pregnancy
• Of Indian descent, born in India, never emigrated out of India, with Indian

home address

• Body mass index (BMI) ≥17 and ≤35 kg/m^2

Exclusion Criteria:

• Presence or history of venous or arterial thrombotic/thromboembolic events

or cerebrovascular accident

• Presence or history of prodromi of a thrombosis
• History of migraine with focal neurological symptoms
• Diabetes mellitus with vascular involvement
• Presence of a severe or multiple risk factor(s) for venous or arterial

thrombosis

• Severe hypertension
• Severe dyslipoproteinemia
• Presence or history of pancreatitis associated with severe

hypertriglyceridemia

• Presence or history of severe hepatic disease
• Undiagnosed vaginal bleeding
• Known or suspected pregnancy
• Currently breastfeeding or breastfeeding within 2 months of starting

trial medication

- Investigational drug use or participation in another clinical trial within

2 months of signing Informed Consent Form for current trial