Relugolix treatment for heavy menstrual bleeding from uterine fibroids

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Peking Union Medical College Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Qi Yu, PhD
• Email: yuqimd@163.com
• Phone: +086-010-69154116

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.