Clinical trial · Interventional
Efficacy and Safety of BG2109 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 BG2109 Alone and in Combination With Add-back Therapy for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women.
- 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 BG2109 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 therapy | Drug | — | UNRESOLVED |
| BG2109 | Drug | — | UNRESOLVED |
| Placebo for add-back therapy | Drug | — | UNRESOLVED |
| Placebo for BG2109 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- BG2109 100mg group
- description
- One tablet of BG2109 100mg + one tablet of placebo for BG2109 + one tablet of placebo for add-back therapy, oral, once-daily.
- interventionNames
- Drug: BG2109
- Drug: Placebo for BG2109
- Drug: Placebo for add-back therapy
- type
- EXPERIMENTAL
- label
- BG2109 200mg+ABT group
- description
- Two tablets of BG2109 100mg + one tablet of add-back therapy, oral, once-daily.
- interventionNames
- Drug: BG2109
- Drug: Add-back therapy
- type
- PLACEBO_COMPARATOR
- label
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: 1. Subject is an 18 years and older premenopausal woman. 2. Subject's Body Mass Index ≥ 18 kg/m2. 3. Subject has a diagnosis of uterine fibroids documented by a pelvic ultrasound. 4. Subject's menstrual cycles is between 21 days and 35 days in the last 3 months. 5. Subject has clinical manifestations of heavy menstrual bleeding. 6. Subject's menstrual blood loss \>80mL for at least 2 menstrual periods assessed at screening using the alkaline hematin method. Key Exclusion Criteria: 1. The subject is pregnant or breast-feeding or is planning a pregnancy within the duration of the treatment period of the study. 2. The subject has a history of uterus surgery that would interfere with the study. 3. The subject's condition is so severe that she will require surgery within 6 months. 4. The subject have had or are currently suffering from any estrogen- dependent malignancy. 5. The subject has a significant risk of osteoporosis, or have a known history of osteoporosis or other metabolic bone disease.
References
Publications (0)
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