CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,577 enrolled
Drug / intervention
15 mg E4/3 mg DRSPdrug
Likely dose
15 mg estetrol and 3 mg drospirenone, one tablet orally once daily for 24 consecutive days followed by one placebo tablet daily for 4 consecutive days, repeated for 13 cyclesAI-extracted
Key inclusion· 5
  • ✓Heterosexually active female at risk for pregnancy and requesting contraception
  • ✓Negative serum pregnancy test at enrollment
  • ✓BMI ≤35.0 kg/m²
  • ✓Good physical and mental health based on medical, surgical, gynecological history, physical examination, and laboratory findings
Key exclusion· 17
  • ✕Known hypersensitivity to investigational product ingredients
  • ✕Smoking if ≥35 years old at screening
  • ✕Dyslipoproteinemia requiring active treatment with antilipidemic agent
  • ✕Diabetes mellitus with vascular complications or >20-year duration

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02817828
NCT02817828Phase 3Completed
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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

Estetra·interventional·Posted Jun 29, 2016·Updated Oct 4, 2019

In Brief

A Phase 3 clinical trial evaluating 15 mg E4/3 mg DRSP for Contraception. Completed, enrolled 1,577 participants across 1 site.

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 18 to 50 years.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsContraception
CountriesBelgium
CollaboratorsPRA Health Sciences

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 29, 2016
Enrollment StartJun 1, 2016
Primary CompletionApr 26, 2018
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 10.0 years ago

Interventions

15 mg E4/3 mg DRSPdrug

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.