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Glucagon-like peptide-1 receptor agonist

Semaglutide for Polycystic Ovary Syndrome (RESTORE Trial)

Phase 3
Recruiting
Led By Melanie Cree-Green, MD,PhD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with PCOS per the most stringent NIH criteria with adaptation for adolescents (oligomenorrhea >24 months post-menarche or primary amenorrhea after age 15 years and clinical/ biochemical hypertestosteronemia
If 18-35 years, initial BMI ≥30 kg/m2 OR initial BMI ≥27 kg/m2 with at least one weight-related comorbid condition, e.g., hypertension or dyslipidemia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights

RESTORE Trial Summary

This trial will study how a GLP-1 receptor agonist can help reduce obesity, weight loss and improve reproduction in girls and women aged 12-35 with PCOS.

Who is the study for?
This trial is for girls and women aged 12-35 with obesity and polycystic ovary syndrome (PCOS), who may or may not be taking metformin. Participants should exercise less than 2 hours a week, have irregular periods, and meet specific PCOS criteria. They must not use hormonal contraception but can use non-hormonal methods.Check my eligibility
What is being tested?
The study tests the effects of Semaglutide (Wegovy) on metabolic changes, weight loss, and reproductive health in participants with PCOS over 10 months. Some will also continue their metformin treatment if they've been stable on it for at least three months.See study design
What are the potential side effects?
Semaglutide might cause digestive issues like nausea or diarrhea, potential allergic reactions, increased heart rate, pancreatitis risk increase, kidney problems or gallbladder issues.

RESTORE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with PCOS following strict NIH criteria, including irregular periods or high testosterone.
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I am 18-35 years old with a BMI of 30 or more, or a BMI of 27 or more with a condition like high blood pressure.
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I am female.
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I am between 12 and 35 years old.
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I am under 18 and my BMI is in the top 5% for my age.
Select...
I have been taking at least 1500 mg of metformin daily for over 3 months.

RESTORE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of ovulation

RESTORE Trial Design

2Treatment groups
Experimental Treatment
Group I: SemaglutideExperimental Treatment1 Intervention
Participants with PCOS who are not on metformin or hormonal therapy, will receive 10-months of semaglutide intervention
Group II: Metformin + SemaglutideExperimental Treatment2 Interventions
Participants with PCOS who are currently on metformin and still not having regular menses, will receive 10-months of semaglutide intervention

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,965 Previous Clinical Trials
2,672,717 Total Patients Enrolled
32 Trials studying Polycystic Ovary Syndrome
5,438 Patients Enrolled for Polycystic Ovary Syndrome
University of Colorado, DenverLead Sponsor
1,738 Previous Clinical Trials
2,149,446 Total Patients Enrolled
5 Trials studying Polycystic Ovary Syndrome
918 Patients Enrolled for Polycystic Ovary Syndrome
Melanie Cree-Green, MD,PhDPrincipal InvestigatorUniversity of Colorado Anschutz/Children's Hospital Colorado

Frequently Asked Questions

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

Has the FDA officially sanctioned Metformin + Semaglutide as a valid treatment?

"The safety of the Metformin + Semaglutide combo has been assigned a rating of 3 on our team's scale, considering there is enough evidence to support its efficacy and multiple studies that attest to its safety."

Answered by AI

What is the participation rate of this healthcare experiment?

"Affirmative. The clinical trial hosted on clinicaltrials.gov indicates that the medical study, which was made public on November 3rd 2023, is currently enrolling patients for participation. Approximately 80 individuals are being sought from one facility to join this project."

Answered by AI

Is there an age restriction for participation in this experimental program?

"The entry requirements for this medical trial necessitate that the participants are between 12 and 35 years old."

Answered by AI

Is it still possible for participants to join this research?

"Clinicaltrials.gov indicates that this experiment is currently recruiting volunteers; the trial was initially posted on November 3rd 2023 and its details were most recently amended on November 21st 2023."

Answered by AI

What criteria must applicants meet to be admitted into this clinical trial?

"This study is open to applicants aged 12-35 who have been diagnosed with polycystic ovary syndrome, and has room for 80 individuals."

Answered by AI

Who else is applying?

What site did they apply to?
University of Colorado Anschutz/Children's Hospital Colorado Aurora
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

I’ve tried diet changes, exercise and treatment like metformin without much luck. I’m hoping this trial could improve the symptoms of my PCOS.
PatientReceived 2+ prior treatments
I’ve tried multiple other drugs, including metformin, and spironolactone and natural supplements to help with the obesity side of PCOS, including my insulin resistance. I have gained 50 pounds in about 2 1/2 years and I cannot lose weight whatsoever in regards to my PCOS and it’s becoming an issue with my daily life. I have been prescribed with obesity medication but the insurance company has said that I am not qualified based on Their recommendations.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How long should I expect to be onsite for trial screening?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Role of Semaglutide in Restoring Ovulation in Youth and Adults With Polycystic Ovary Syndrome
2023. "Role of Semaglutide in Restoring Ovulation in Youth and Adults With Polycystic Ovary Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05819853.
All > Pcos
~53 spots leftby Feb 2028
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