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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Contraception

Intervention / Treatment
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* Drug: Nomegestrol acetate (NOMAC)
* Drug: Estradiol (E2)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NOMAC-E2 2.5 mg/1.5 mg<br>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. | Drug: Nomegestrol acetate (NOMAC)<br>* Oral tablet with daily release of 2.5 mg<br>Drug: Estradiol (E2)<br>* Daily release of 1.5 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of In-treatment Pregnancies |  | Day 1 of Treatment Cycle 1 Through Day 28 of Treatment Cycle 13, plus up to 2 additional days (Study Days 1-366) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Experiencing an Adverse Event (AE) or Serious AE |  | From Visit 1 up to 30 days after the last dose of study medication (up to Study Day 394). |