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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Contraception
• Intervention / Treatment: Drug: Nomegestrol acetate (NOMAC); Drug: Estradiol (E2)

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Nomegestrol acetate (NOMAC); Oral tablet with daily release of 2.5 mg; Drug: Estradiol (E2); Daily release of 1.5 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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).

Collaborators and Investigators

• Sponsor: Organon and Co

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Anticipated): May 1, 2015
• Study Completion (Anticipated): May 1, 2015

Study Registration Dates

• First Submitted: November 6, 2012
• First Submitted That Met QC Criteria: November 6, 2012
• First Posted (Estimate): November 8, 2012

Study Record Updates

• Last Update Posted (Actual): February 16, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens; Estradiol
• Other Study ID Numbers: P07057; MK-8175A-017 (Other Identifier: Merck)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No