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
2 other identifiers
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2013
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 6, 2012
CompletedFirst Posted
Study publicly available on registry
November 8, 2012
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedFebruary 16, 2022
February 1, 2022
1.8 years
November 6, 2012
February 7, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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).
Study Arms (1)
NOMAC-E2 2.5 mg/1.5 mg
EXPERIMENTALParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Organon and Colead
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2012
First Posted
November 8, 2012
Study Start
July 1, 2013
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
February 16, 2022
Record last verified: 2022-02