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NCT02817841 · ClinicalTrials.gov registry record · Phase 3
E4 FREEDOM (Female Response Concerning Efficacy and Safety of Estetrol/Drospirenone as Oral Contraceptive in a Multicentric Study) - United States/Canada Study
A Phase 3 study, sponsored by Estetra.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,148
- Enrollment target
NCT02817841: Completed Phase 3 study, sponsored by Estetra.
NCT02817841 is a Phase 3 study that has completed, run by Estetra. The registered enrollment target is 2,148 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (178% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02817841, a Phase 3 study, has completed, sponsored by Estetra.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,148 participants
- Enrollment target
Study 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.
Primary Outcome
On-treatment pregnancies are pregnancies with an estimated date of conception within the in-treatment period i.e. Day 1 to 7 days after the last intake of investigational product (whether active or inactive tablet). The Pearl Index, defined as the number of pregnancies per 100 women-years of treatment was calculated as: Pearl Index = (1300\*number of on-treatment pregnancies)/number of women 28-day equivalent cycles of treatment. Only at-risk cycles were included in the denominator of the Pearl
Interventions
- DRUG 15 mg E4/3 mg DRSP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,148 participants |
| Start Date | 2016-08-30 |
| Est. Completion | 2018-11-16 |
| Phase | Phase 3 |
What the finished NCT02817841 record still lists
NCT02817841 is an interventional study that assigns participants to a tested intervention. Its 2,148 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (178% higher).
The record links to 0 conditions, and to 1 intervention - of which 15 mg E4/3 mg DRSP is the first listed.
NCT02817841 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02817841 about?
NCT02817841 is a clinical study titled "E4 FREEDOM (Female Response Concerning Efficacy and Safety of Estetrol/Drospirenone as Oral Contraceptive in a Multicentric Study) - United States/Canada Study". 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.
What is the current status of trial NCT02817841?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,148 participants. The study started on 2016-08-30. Estimated completion is 2018-11-16.
What interventions are being tested in trial NCT02817841?
The interventions under investigation include: 15 mg E4/3 mg DRSP (DRUG).
Who is sponsoring clinical trial NCT02817841?
This trial is sponsored by Estetra, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02817841's enrollment target sits among peer trials
2,148 96th of 2000 higher than 1,905 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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