Contraception
Conditions
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.
Interventions
Oral tablet with daily release of 2.5 mg
DRUGEstradiol (E2)
Daily release of 1.5 mg
Sponsors
Organon and Co
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| 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
| 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). |
Outcome results
None listed