Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Recruiting
Phase 3
Interventional Study
Heavy Menstrual Bleeding
Uterine Fibroids
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 120 (estimated)
- Sponsor
- Qilu Pharmaceutical Co., Ltd. · Industry
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
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 wome…
Trial Locations
Loading…
Loading trial locations…
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 classifi…
Contacts