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Tests treatment safety and results for Heavy Menstrual Bleeding
Official title Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
ClinicalTrials.gov ID: NCT06671548
What this study is testing
What is Relugolix?
Relugolix is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for heavy menstrual bleeding.
Also referred to as megestrol acetate, medroxyprogesterone acetate.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
You likely can't join if
- 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...
- 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...
See the full eligibility 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
- 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; people who can remove the IUD/subdermal contraceptive implant at...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.