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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

SERENE Trial 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.Check my eligibility
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.See study design
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.

SERENE Trial 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.
Select...
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.
Select...
What is your weight in pounds?

SERENE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Contraceptive Efficacy of Relugolix Combination Therapy as Assessed by the At-Risk Pearl Index (PI)
Secondary outcome measures
Contraceptive Efficacy of Relugolix Combination Therapy as Assessed by the Cumulative 1-Year Pregnancy Rates
Contraceptive Efficacy of Relugolix Combination Therapy as Assessed by the Gross PI
Combined Modality Therapy
+5 more

SERENE 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
14 Previous Clinical Trials
2,473 Total Patients Enrolled
Myovant Sciences GmbHLead Sponsor
22 Previous Clinical Trials
11,470 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research allow senior citizens to participate?

"The age requirements for this clinical trial are that patients must be 18 years old or older, but younger than 50."

Answered by AI

Do the guidelines for this research allow for my participation?

"Contraception use is a must for participants between the ages of 18-50 who want to be included in this clinical trial. Up to 1020 people are needed for the study."

Answered by AI

What have patients been using Relugolix Combination Therapy to treat?

"Relugolix Combination Therapy is often used to manage advanced androgen dependent prostate cancer. However, this course of treatment can also help with other conditions including amenorrhea, hypoestrogenism, and menopausal vasomotor symptoms."

Answered by AI

Could you please remind me of the risks associated with taking Relugolix Combination Therapy?

"Given that this is a Phase 3 trial with evidence of efficacy and safety, our team has estimated the safety of Relugolix Combination Therapy to be a 3."

Answered by AI

Are there any open positions for patients in this trial?

"Yes, the trial is still ongoing and recruiting patients. The study was first posted on March 18th, 2021 and was most recently updated on October 10th, 2022. They are looking for 1020 patients from 80 different sites."

Answered by AI

Where are patients being treated in this clinical trial?

"There are 80 enrolling patients for this clinical trial at 80 locations, some of which include Middleton in Middleton, Philadelphia in Philadelphia, and Summerville in Summerville."

Answered by AI

How many study subjects are included in this research project?

"In order to obtain accurate and reliable results, the study requires 1020 individuals that meet the pre-specified inclusion criteria. Those who are interested and eligible can participate in the trial at one of the many locations, including Middleton, Wisconsin and Philadelphia, Pennsylvania."

Answered by AI

Does the research on Relugolix Combination Therapy stand alone, or has it been corroborated by other scientific teams?

"The first instance of study for Relugolix Combination Therapy was at National Institutes of Health Clinical Center in 1996. Since then, there have been a total of 270 completed trials. As of now, 62 trials are actively recruiting, many of which are based in Middleton, Wisconsin."

Answered by AI

Who else is applying?

What state do they live in?
California
Nevada
Texas
Other
How old are they?
18 - 65
What site did they apply to?
Denver
Houston
North Las Vegas
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Interested in trying . Don't want to have more kids. I’m dealing with the symptoms of uterine fibroids.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Study of the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women With Uterine Fibroids or Endometriosis Who Are at Risk for Pregnancy
2021. "Study of the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women With Uterine Fibroids or Endometriosis Who Are at Risk for Pregnancy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04756037.
All > Uterine Fibroids > Fibroids
~200 spots leftby Feb 2025
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