Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study of Uterine Fibroids and Heavy Menstrual Bleeding, sponsored by ObsEva.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Assessed using the alkaline hematin method
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 |
What the finished NCT03070899 record still lists
NCT03070899 is an interventional study that assigns participants to a tested intervention. The registered 526 participants enrollment target is mid-sized for trials with a published cap, above the 192-participant average among 10 other Uterine Fibroids trials with a reported enrollment target (174% higher).
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 names 20 study sites across 4 states, led by 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.
Learn More About Clinical Trials
Similar trials for Uterine Fibroids
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03070899's enrollment target sits among peer trials
526 3rd of 10 higher than 8 of 10 other Uterine Fibroids trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Uterine Fibroids 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
-
A Phase 3B Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Women With Uterine Fibroids or Endometriosis
RECRUITING · Phase 3
-
An Open-Label Study to Evaluate the Effect of Elix Cycle Balance & Elix Daily Harmony on Fibroid-related Symptoms
RECRUITING · NA
-
Effect of Addition of Steroids on Duration of Analgesia
ACTIVE NOT RECRUITING · Early Phase 1
-
Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry
ACTIVE NOT RECRUITING
-
Uterine Leiomyoma Treatment With Radiofrequency Ablation
COMPLETED · NA
-
Extension Study of Proellex in Women Who Have Previously Completed Study ZPU 003
COMPLETED · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04738825 · 526 participants · NA
Promoting HIV Risk Reduction Among People Who Inject Drugs: A Stepped Care Approach Using Contingency Management With PrEP Adherence and Support Services
- NCT04769492 · 525 participants · NA
#ChopViolence/#ChopHIV
- NCT05260047 · 525 participants · NA
Culturally Responsive Community Driven Substance Use Recovery for Black and Latinx Population
- NCT05620719 · 525 participants · NA
Multisite Advancement of Research on Chronic Posttraumatic Headache
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI