Relugolix treatment for heavy menstrual bleeding from 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
This trial will test whether taking relugolix 40 mg once daily can reduce heavy menstrual bleeding in premenopausal women with uterine fibroids compared with placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Qilu Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06671548 on ClinicalTrials.gov |
What this trial studies
This is a phase 3, randomized, double-blind, placebo-controlled trial enrolling about 120 premenopausal women with heavy menstrual bleeding due to uterine fibroids, randomized 2:1 to relugolix 40 mg or placebo for 12 weeks followed by 12 weeks of open-label relugolix with add-back hormones. Menstrual blood loss is measured by the alkaline hematin method and stratified by baseline volume (<225 mL vs ≥225 mL). Safety monitoring includes adverse events, vital signs, labs, ECGs, physical exams, and bone mineral density assessments. The primary aim is to compare bleeding reduction and safety between the relugolix and placebo groups over the double-blind period.
Who should consider this trial
Good fit: Premenopausal women aged 18 or older with ultrasound-confirmed uterine fibroids and heavy menstrual bleeding who can comply with study procedures and provide informed consent are ideal candidates.
Not a fit: Women with a history of osteoporosis or other metabolic bone disease, recent malignancy, prior failed GnRH therapy for fibroids, or those planning hysterectomy/oophorectomy are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, relugolix could substantially reduce heavy menstrual bleeding and offer a non-surgical treatment option for women with fibroids.
How similar studies have performed: Other phase 3 trials of relugolix with add-back therapy have shown positive results in reducing fibroid-related bleeding and have supported regulatory approvals of relugolix combinations, although the specific add-back regimen in this trial is less commonly reported.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing
- Peking Union Medical College Hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Qi Yu, PhD
- Email: yuqimd@163.com
- Phone: +086-010-69154116
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.