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

• Status: Withdrawn
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Megestrol; Polyestradiol phosphate

Criteria

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