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

Launched by ORGANON AND CO · Nov 6, 2012

Keywords

ClinConnect Summary

No description provided

Gender

FEMALE

Eligibility 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