Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 3 study that has completed, run by ObsEva. The registered enrollment target is 511 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03070951
The ClinicalTrials.gov registry entry for NCT03070951 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 511 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ObsEva, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which OBE2109 is the first listed.
NCT03070951 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.