NCT06671548 Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
| NCT ID | NCT06671548 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Qilu Pharmaceutical Co., Ltd. |
| Condition | Heavy Menstrual Bleeding |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-01-15 |
| Primary Completion | 2026-11-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 120 participants in total. It began in 2024-01-15 with a primary completion date of 2026-11-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06671548 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Heavy Menstrual Bleeding. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06671548 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 120 participants.
Is NCT06671548 currently recruiting?
Yes, NCT06671548 is actively recruiting participants. Contact the research team at yuqimd@163.com for enrollment information.
Where is the NCT06671548 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06671548 clinical trial?
NCT06671548 is sponsored by Qilu Pharmaceutical Co., Ltd.. The trial plans to enroll 120 participants.