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

Phase 3

Withdrawn

• Conditions: Contraception
• Interventions: Drug: Nomegestrol acetate (NOMAC); Drug: Estradiol (E2)

• Registration Number: NCT01723579
• Lead Sponsor: Organon and Co

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-06
• Study First Submitted QC: 2012-11-06
• Study First Posted: 2012-11-08
• Study Start: 2013-07
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NOMAC-E2 2.5 mg/1.5 mg	Nomegestrol acetate (NOMAC)	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.
NOMAC-E2 2.5 mg/1.5 mg	Estradiol (E2)	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).