Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorQilu Pharmaceutical Co., Ltd.
About this trial
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
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Relugolix
- Relugolix placebo
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov