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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Relugolix
Drug* Relugolix (40 mg) tablet administered orally once daily； * megestrol acetate (1 mg) administered orally once daily； * medroxyprogesterone acetate (2 mg) administered orally once daily
Relugolix placebo
DrugRelugolix (0 mg) tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor. megestrol acetate (0 mg) administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor. medroxyprogesterone acetate (0 mg) administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Relugolix plus megestrol acetate/medroxyprogesterone acetate (the treatment group)Experimental treatment 1 intervention
Group B: Placebo (the placebo group)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percentage Of Participants Who Achieved A Menstrual Blood Loss (MBL) Volume Of < 80 mL And ≥ 50% Reduction From Baseline MBL Volume
A responder was a participant who had MBL volume of \< 80 mL and at least a 50% reduction from baseline MBL volume over the last 35 days of the double-blind treatment period. All returned feminine products collected at each clinical visit were analyzed by the alkaline hematin method to obtain the MBL volume. MBL volume was measured over the Week 12/early termination feminine product collection interval (up to 35 days prior to the last dose of double-blind treatment). The percentage of participants who were responders are presented. As per the objective of the study, the pre-specified primary efficacy analyses compared relugolix plus megestrol acetate 1 mg and medroxyprogesterone acetate 2 mg with placebo. Therefore, only relugolix plus megestrol acetate 1 mg and medroxyprogesterone acetate 2 mg and placebo arms are presented.
Time frame
From Baseline up to the last 35 days of the double-blind treatment periodSecondary outcomes
1
Percentage Of Participants With Amenorrhea Over The Last 35 Days Of the double-blind treatment period
Following the administration of the investigational product, amenorrhea was defined as the central laboratory-confirmed measurement of blood loss volume \<5 mL (including no bleeding) over a continuous 56-day period using feminine products. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus megestrol acetate 1 mg and medroxyprogesterone acetate 2 mg with placebo. Therefore, only relugolix plus megestrol acetate 1 mg and medroxyprogesterone acetate 2 mg and placebo arms are presented.
Time frame
From Baseline up to the last 35 days of the double-blind treatment periodSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov