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

NCT ID: NCT01723579

Last Updated: 2022-02-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2015-05-31

Brief 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.

Conditions

Contraception

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NOMAC-E2 2.5 mg/1.5 mg

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.

Group Type: EXPERIMENTAL

Nomegestrol acetate (NOMAC)

Intervention Type: DRUG

Oral tablet with daily release of 2.5 mg

Estradiol (E2)

Intervention Type: DRUG

Daily release of 1.5 mg

Interventions

Nomegestrol acetate (NOMAC)

Oral tablet with daily release of 2.5 mg

Intervention Type: DRUG

Estradiol (E2)

Daily release of 1.5 mg

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

MK-8175A-017

Identifier Type: OTHER

Identifier Source: secondary_id

P07057

Identifier Type: -

Identifier Source: org_study_id