At a glance
ClinicalIndex Comparison Record- ✓Heterosexually active female requesting contraception
- ✓Negative serum pregnancy test at screening
- ✓Willing to use investigational product as primary contraception for 13 cycles
- ✓Body mass index ≤35.0 kg/m²
- ✕Hypersensitivity to any investigational product ingredient
- ✕Smoking if ≥35 years old
- ✕Any condition associated with increased risk of venous or arterial thromboembolism
- ✕Diabetes mellitus with vascular involvement or >20 years duration
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Open-label, Single-Arm Study to Evaluate the Contraceptive Efficacy and Safety of a Combined Oral Contraceptive Containing 15 mg Estetrol and 3 mg Drospirenone
In Brief
A Phase 3 clinical trial evaluating 15 mg E4/3 mg DRSP for Contraception. Completed, enrolled 2,148 participants across 2 sites in 2 countries.
Detailed Summary
The objectives of this study are to evaluate the contraceptive efficacy, vaginal bleeding pattern (cycle control), and the general safety and acceptability of the 15 mg estetrol (E4)/3 mg drospirenone (DRSP) combination in healthy women aged 16 to 50 years.
Study Details
Timeline
Interventions
15 mg estetrol and 3 mg drospirenone tablets administered once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.