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NCT03070951 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids
A Phase 3 study, sponsored by ObsEva.
- Completed
- Registry status
- Phase 3
- Development phase
- 511
- Enrollment target
NCT03070951: Completed Phase 3 study, sponsored by ObsEva.
NCT03070951 is a Phase 3 study that has completed, run by ObsEva. The registered enrollment target is 511 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03070951, a Phase 3 study, has completed, sponsored by ObsEva.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 511 participants
- Enrollment target
Study Summary
The primary objective of this study is to demonstrate the superior efficacy versus placebo of OBE2109 alone and in combination with add-back therapy for the reduction of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
Primary Outcome
Assessed using the alkaline hematin method
Interventions
- DRUG OBE2109
- DRUG Placebo to match OBE2109
- DRUG Placebo to match Add-back
- DRUG Add-back
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 511 participants |
| Start Date | 2017-05-23 |
| Est. Completion | 2020-10-04 |
| Phase | Phase 3 |
What the finished NCT03070951 record still lists
NCT03070951 is an interventional study that assigns participants to a tested intervention. The registered 511 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 (34% lower).
The record links to 0 conditions, and to 4 interventions - of which OBE2109 is the first listed.
NCT03070951 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03070951 about?
NCT03070951 is a clinical study titled "Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids". The primary objective of this study is to demonstrate the superior efficacy versus placebo of OBE2109 alone and in combination with add-back therapy for the reduction of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
What is the current status of trial NCT03070951?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 511 participants. The study started on 2017-05-23. Estimated completion is 2020-10-04.
What interventions are being tested in trial NCT03070951?
The interventions under investigation include: OBE2109 (DRUG), Placebo to match OBE2109 (DRUG), Placebo to match Add-back (DRUG), Add-back (DRUG).
Who is sponsoring clinical trial NCT03070951?
This trial is sponsored by ObsEva, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03070951's enrollment target sits among peer trials
511 728th of 2000 higher than 1,272 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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