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Gonadotropin-Releasing Hormone (GnRH) Antagonist

Relugolix Combination Therapy for Birth Control (SERENE Trial)

Phase 3
Waitlist Available
Research Sponsored by Sumitomo Pharma Switzerland GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Is a premenopausal woman, 18 to 50 years of age.
Is at risk of pregnancy (that is, having heterosexual intercourse at least once per month) and is seeking contraception.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months on-treatment or eot
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial will test how well a combination of drugs called relugolix works as a contraceptive in women.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While not explicitly listed here, potential side effects may include hormonal changes typical of contraceptives such as mood swings, weight gain, headaches, nausea, and possibly specific effects related to Relugolix like bone density reduction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman aged 18 to 50 and have not gone through menopause.
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I am at risk of pregnancy and seeking contraception.
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You have menstrual cycles that are regular, occurring every 21 to 35 days.
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I have uterine fibroids diagnosed by ultrasound in the last 2 years and they cause me heavy menstrual bleeding.
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I have been diagnosed with endometriosis, confirmed by surgery or biopsy, and I experience significant pain.
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You must use the study treatment as your only form of birth control for 13 months and cannot use any other contraception methods like condoms.
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This is not an exclusion criterion, but rather a question to gather information about the participant's height.
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What is your weight in pounds?

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months on-treatment or eot
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months on-treatment or eot for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Contraceptive Efficacy of Relugolix Combination Therapy as Assessed by the At-Risk Pearl Index (PI)
Secondary study objectives
Contraceptive Efficacy of Relugolix Combination Therapy as Assessed by the Gross PI
Combined Modality Therapy
Contraceptive Efficacy of Relugolix Combination Therapy as Assessed by the Modified At-Risk PI
+2 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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 Location

Who is running the clinical trial?

Sumitomo Pharma Switzerland GmbHLead Sponsor
17 Previous Clinical Trials
4,921 Total Patients Enrolled
Myovant Sciences GmbHLead Sponsor
22 Previous Clinical Trials
11,443 Total Patients Enrolled

Media Library

Relugolix Combination Therapy (Gonadotropin-Releasing Hormone (GnRH) Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04756037 — Phase 3
Birth Control Research Study Groups: Relugolix/E2/NETA
Birth Control Clinical Trial 2023: Relugolix Combination Therapy Highlights & Side Effects. Trial Name: NCT04756037 — Phase 3
Relugolix Combination Therapy (Gonadotropin-Releasing Hormone (GnRH) Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04756037 — Phase 3
~44 spots leftby Feb 2025
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