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
Overview
- Phase
- Phase 3
- Intervention
- Nomegestrol acetate (NOMAC)
- Conditions
- Contraception
- Sponsor
- Organon and Co
- Primary Endpoint
- Number of In-treatment Pregnancies
- Status
- Withdrawn
- Last Updated
- 4 years ago
Overview
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.
Investigators
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
- •Severe hypertension
- •Severe dyslipoproteinemia
- •Presence or history of pancreatitis associated with severe
- •hypertriglyceridemia
Arms & Interventions
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.
Intervention: Nomegestrol acetate (NOMAC)
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.
Intervention: Estradiol (E2)
Outcomes
Primary Outcomes
Number of In-treatment Pregnancies
Time Frame: 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
- 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).)