Relugolix Combination Therapy for Birth Control

(SERENE Trial)

Recruiting at 114 trial locations

Overseen By Myovant Medical Monitor Study Director

Age: 18 - 65

Sex: Female

Trial Phase: Phase 3

Sponsor: Sumitomo Pharma Switzerland GmbH

Must not be taking: Isotretinoin, Thalidomide

Disqualifiers: Pregnancy, Infertility, Thromboembolic events, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

1020 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess the contraceptive efficacy of relugolix combination therapy.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you must use the study intervention as your only method of contraception during the trial.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive relugolix combination therapy for contraceptive efficacy over 13 consecutive 28-day treatment cycles

12 months

Follow-up

Participants are monitored for safety and effectiveness, including bone mineral density changes, after treatment

12 months

Treatment Details

Interventions

• Relugolix Combination Therapy

Trial Overview The 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

Group I: Relugolix/E2/NETA Experimental Treatment 1 Intervention

Participants will receive relugolix combination therapy for 1 year (13 consecutive 28-day treatment cycles).

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+