Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Launched by QILU PHARMACEUTICAL CO., LTD. · Nov 1, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called relugolix to see if it can help women who experience heavy menstrual bleeding due to uterine fibroids. The main aim is to find out if taking 40 milligrams of relugolix once a day is more effective than taking a placebo (a pill with no active ingredients). Researchers are also looking at how safe this medication is for women with this condition.

To participate in the trial, women need to be between 18 and 50 years old and have a confirmed diagnosis of uterine fibroids causing heavy menstrual bleeding. They must also be able to understand the study and agree to take part. The trial is not recruiting participants yet, so it’s still in the planning stages. If you join, you can expect regular visits for check-ups to monitor your progress and any side effects from the medication. It's important to note that certain medical histories, like previous surgeries or specific health conditions, might prevent someone from participating.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Premenopausal female aged 18 to 50 years old (inclusive)
• • Diagnosis of uterine fibroids confirmed by transvaginal 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.