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NCT03070899 · 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 of Uterine Fibroids and Heavy Menstrual Bleeding, sponsored by ObsEva.
- Completed
- Registry status
- Phase 3
- Development phase
- 526
- Enrollment target
- 20
- Study locations
NCT03070899 is a Phase 3 study of Uterine Fibroids and Heavy Menstrual Bleeding that has completed, run by ObsEva. The registered enrollment target is 526 participants, above the 192-participant average among 10 other Uterine Fibroids trials with a reported enrollment target (174% higher). The trial reports 20 study locations across 4 states.
The verdict
NCT03070899, a Phase 3 study of Uterine Fibroids and Heavy Menstrual Bleeding, has completed, sponsored by ObsEva.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 526 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
Interventions
- DRUG OBE2109
- DRUG Placebo to match OBE2109
- DRUG Placebo to match Add-back
- DRUG Add-back
Study Locations (20)
California
- Site reference ID 211 - Arcadia
- Site reference ID 184 - Cerritos
- Site reference ID 147 - Escondido
- Site reference ID 154 - Huntington Park
- Site reference ID 185 - Los Angeles
- Site reference ID 199 - Northridge
- Site reference ID 111 - Panorama City
- Site reference ID 166 - Sacramento
- Site reference ID 101 - San Diego
- Site reference ID 239 - Upland
- Site reference ID 112 - Westminster
Alabama
- Site reference ID 192 - Birmingham
- Site reference ID 169 - Dothan
- Site reference ID 353 - Mobile
- Site reference ID 232 - Vestavia Hills
Colorado
- Site reference ID 144 - Denver
- Site reference ID 246 - Englewood
- Site reference ID 234 - Thornton
Arizona
- Site reference ID 242 - Phoenix
- Site reference ID 355 - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 526 participants |
| Start Date | 2017-04-20 |
| Est. Completion | 2021-04-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03070899
The ClinicalTrials.gov registry entry for NCT03070899 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 526 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 192-participant average among 10 other Uterine Fibroids trials with a reported enrollment target (174% higher). The listed sponsor is ObsEva, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Uterine Fibroids appearing as the primary indexed condition, and to 4 interventions - of which OBE2109 is the first listed.
NCT03070899 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Alabama, Colorado.
Frequently Asked Questions
What is clinical trial NCT03070899 about?
NCT03070899 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 NCT03070899?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 526 participants. The study started on 2017-04-20. Estimated completion is 2021-04-12.
What conditions does trial NCT03070899 study?
This clinical trial studies the following conditions: Uterine Fibroids, Heavy Menstrual Bleeding.
What interventions are being tested in trial NCT03070899?
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 NCT03070899?
This trial is sponsored by ObsEva, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03070899 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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