Relugolix Combination Therapy for Birth Control
(SERENE Trial)
Recruiting at 111 trial locations
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Sumitomo Pharma Switzerland GmbH
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
The purpose of this study is to assess the contraceptive efficacy of relugolix combination therapy.
Eligibility Criteria
This trial is for premenopausal women aged 18-50 who are at risk of pregnancy and seeking contraception. Participants must be willing to use the study drug as their only birth control method for over a year. They should have either endometriosis confirmed by surgery or severe menstrual pain, or uterine fibroids diagnosed via ultrasound with heavy bleeding.Inclusion Criteria
You have menstrual cycles that are regular, occurring every 21 to 35 days.
I have uterine fibroids diagnosed by ultrasound in the last 2 years and they cause me heavy menstrual bleeding.
I have been diagnosed with endometriosis, confirmed by surgery or biopsy, and I experience significant pain.
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Treatment Details
Interventions
- Relugolix Combination Therapy (Gonadotropin-Releasing Hormone (GnRH) Antagonist)
Trial OverviewThe trial is testing Relugolix Combination Therapy's ability to prevent pregnancy in women with uterine fibroids or endometriosis. It will measure how effective this therapy is when used as the sole contraceptive method across multiple menstrual cycles.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Relugolix/E2/NETAExperimental Treatment1 Intervention
Participants will receive relugolix combination therapy for 1 year (13 consecutive 28-day treatment cycles).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sumitomo Pharma Switzerland GmbH
Lead Sponsor
Trials
19
Recruited
6,900+
Myovant Sciences GmbH
Lead Sponsor
Trials
23
Recruited
12,500+