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NCT02985541 · ClinicalTrials.gov registry record · Phase 3
Mirena Extension Trial
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 364
- Enrollment target
NCT02985541: Completed Phase 3 study, sponsored by Bayer.
NCT02985541 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 364 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02985541, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 364 participants
- Enrollment target
Study Summary
The study is performed to assess if Mirena is effective and safe as a birth control method beyond 5 years of use. Further the menstrual blood loss (in women that had Mirena inserted for the indication heavy menstrual bleeding \[HMB\]) and safety will be assessed.
Primary Outcome
The Pearl Index (PI) is defined as the number of pregnancies per 100 women years. The 3-year PI (Years 6 to 8) was obtained by dividing the number of pregnancies the occurred during that time (starting at Day 1 Year 6 and up to Day 365 of Year 8) by the time (in 100 women years) that the women were at risk of getting pregnant during that time.
Interventions
- DRUG Levonorgestrel IUS (Mirena, BAY86-5028)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 364 participants |
| Start Date | 2016-12-22 |
| Est. Completion | 2021-05-28 |
| Phase | Phase 3 |
What the finished NCT02985541 record still lists
NCT02985541 is an interventional study that assigns participants to a tested intervention. The registered 364 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 1 intervention - of which Levonorgestrel IUS (Mirena, BAY86-5028) is the first listed.
NCT02985541 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02985541 about?
NCT02985541 is a clinical study titled "Mirena Extension Trial". The study is performed to assess if Mirena is effective and safe as a birth control method beyond 5 years of use. Further the menstrual blood loss (in women that had Mirena inserted for the indication heavy menstrual bleeding \[HMB\]) and safety will be assessed.
What is the current status of trial NCT02985541?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 364 participants. The study started on 2016-12-22. Estimated completion is 2021-05-28.
What interventions are being tested in trial NCT02985541?
The interventions under investigation include: Levonorgestrel IUS (Mirena, BAY86-5028) (DRUG).
Who is sponsoring clinical trial NCT02985541?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02985541's enrollment target sits among peer trials
364 1003rd of 2000 higher than 996 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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