Clinical trial · Interventional
Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids
A Phase 3, Multicentre, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy and Safety of Daily Oral Administration of OBE2109 Alone and in Combination With Add-back Therapy for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
NCT03070951CI-TRIAL-00050491PRIMROSE 2completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Heavy Menstrual Bleeding | — | UNRESOLVED | — |
| Uterine Fibroids | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Add-back | Drug | — | UNRESOLVED |
| OBE2109 | Drug | — | UNRESOLVED |
| Placebo to match Add-back | Drug | — | UNRESOLVED |
| Placebo to match OBE2109 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- OBE2109 dose 1 (100mg) + Placebo Add-back
- interventionNames
- Drug: OBE2109
- Drug: Placebo to match OBE2109
- Drug: Placebo to match Add-back
- type
- EXPERIMENTAL
- label
- OBE2109 dose 1 (100mg) + Add-back
- interventionNames
- Drug: OBE2109
- Drug: Placebo to match OBE2109
- Drug: Add-back
- type
- EXPERIMENTAL
- label
- OBE2109 dose 2 (200mg) + Placebo Add-back / OBE2109 dose 2 (200 mg) + Add-back
- interventionNames
- Drug: OBE2109
- Drug: Placebo to match Add-back
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Premenopausal woman at screening. * Body Mass Index ≥ 18 kg/m2. * Menstrual cycles ≥ 21 days and ≤ 40 days. * Presence of uterine fibroids. * Heavy menstrual blood loss for each of the 2 menstrual periods assessed at screening using the alkaline hematin method. Key Exclusion Criteria: * The subject is pregnant or breast-feeding or is planning a pregnancy within the duration of the treatment period of the study. * History of uterus surgery that would interfere with the study. * The subject's condition is so severe that she will require surgery within 6 months regardless of the treatment provided. * Undiagnosed abnormal uterine bleeding. * Significant risk of osteoporosis or history of, or known osteoporosis or other metabolic bone disease.
References
Publications (3)
- DERIVEDDonnez J, Petraglia F, Taylor H, Becker CM, Becker S, Herrera FC, Bestel E, Hori S, Dolmans MM. Linzagolix with and without hormonal add-back therapy for symptomatic uterine fibroids: PRIMROSE 1 & 2 long-term extension and withdrawal study. Fertil Steril. 2025 Oct;124(4):737-748. doi: 10.1016/j.fertnstert.2025.06.016. Epub 2025 Jun 19. PMID 40543832
- DERIVEDBecker S, Dolmans MM, Herrera FC, Petraglia F, Renner SP, Ionescu-Ittu R, St-Pierre J, Boolell M, Bestel E, Hori S, Donnez J. Pain Reduction in Linzagolix-Treated Patients With Uterine Fibroids: A Secondary Mediation Analysis of the PRIMROSE 1 and 2 Phase 3 Trials. BJOG. 2025 Aug;132(9):1297-1306. doi: 10.1111/1471-0528.18190. Epub 2025 May 6. PMID 40326221
- DERIVEDDonnez J, Taylor HS, Stewart EA, Bradley L, Marsh E, Archer D, Al-Hendy A, Petraglia F, Watts N, Gotteland JP, Bestel E, Terrill P, Loumaye E, Humberstone A, Garner E. Linzagolix with and without hormonal add-back therapy for the treatment of symptomatic uterine fibroids: two randomised, placebo-controlled, phase 3 trials. Lancet. 2022 Sep 17;400(10356):896-907. doi: 10.1016/S0140-6736(22)01475-1. PMID 36116480