Clinical trial · Interventional
Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Designed Efficacy and Safety Study to Evaluate Relugolix Tablets in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
- 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 goal of this clinical trial is to determine the benefit of relugolix 40 milligrams (mg) once a day compared with placebo in heavy menstrual bleeding associated with uterine fibroids. The main question\[s\] it aims to answer are: * the benefit of relugolix 40 mg once daily in women with heavy menstrual bleeding associated with uterine fibroids * the safety of relugolix 40 mg once daily in women with heavy menstrual bleeding associated with uterine fibroids
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Relugolix | Drug | Relugolix | ALIAS |
| Relugolix placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Relugolix plus megestrol acetate/medroxyprogesterone acetate (the treatment group)
- description
- Relugolix 40 mg co-administered with megestrol acetate 1 mg and medroxyprogesterone acetate 2 mg for 12 weeks followed by 12 weeks of daily oral relugolix 40 mg co-administered with megestrol acetate 1 mg and medroxyprogesterone acetate 2 mg..
- interventionNames
- Drug: Relugolix
- type
- PLACEBO_COMPARATOR
- label
- Placebo (the placebo group)
- description
- Relugolix 40 mg placebo co-administered with megestrol acetate 1 mg placebo and medroxyprogesterone acetate 2 mg placebo for 12 weeks followed by 12 weeks of daily oral relugolix 40 mg co-administered with megestrol acetate 1 mg and medroxyprogesterone acetate 2 mg.
- interventionNames
- Drug: Relugolix placebo
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Premenopausal female aged 18 or older * Diagnosis of uterine fibroids confirmed by transvaginal/rectal ultrasound during the screening period * Heavy menstrual bleeding caused by uterine fibroids * Breast ultrasound results during the screening period meet the BI-RADS classification of 1 to 3 * Able to understand and comply with the study procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing Exclusion Criteria: * History of bilateral oophorectomy, or planned to undergo hysterectomy, bilateral oophorectomy, or other surgical procedures during the study period. * Previous treatment with gonadotropin-releasing hormone (GnRH) agonists or GnRH antagonists for uterine fibroids has failed. * History of or current osteoporosis or other metabolic bone disease. * History of malignant tumor within 5 years prior to screening, except for cured skin cancer, basal cell carcinoma, and other localized malignant tumors. * History of drug abuse, alcohol abuse, or drug dependence within 2 years prior to screening. * Presence of an in situ copper intrauterine device (IUD) or a progestin-containing IUD implant/subdermal contraceptive implant during the screening period; subjects who can remove the IUD/subdermal contraceptive implant at least 1 month before enrollment may be allowed to participate. * Baseline bone mineral density Z-score of \< -2.0 at the lumbar spine, total hip, or femoral neck during the screening period. * Any other factors that the investigator deems unsuitable for participation in this trial.
References
Publications (0)
Data not yet available