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

Organon

Status and phase: Withdrawn; Phase 3

Conditions: Contraception

Treatments: Drug: Nomegestrol acetate (NOMAC); Drug: Estradiol (E2)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01723579

MK-8175A-017 (Other Identifier)

P07057

Details and patient eligibility

About

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.

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

NOMAC-E2 2.5 mg/1.5 mg

Experimental group

Description:

Participants will receive combined oral contraceptive NOMAC-E2 2.5 mg/1.5 mg tablet for 13 consecutive 28-day cycles. Each 28-day cycle with consist of 24 active tablets and 4 placebo tablets taken at approximately the same time each day.

Treatment:

Drug: Estradiol (E2)

Drug: Nomegestrol acetate (NOMAC)