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GLP-1 Receptor Agonist

Semaglutide for Polycystic Ovary Syndrome

Phase 1
Waitlist Available
Research Sponsored by Methodist Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-45
Diagnosis of PCOS
Must not have
Medications excluded: any hormone-containing contraceptive - oral contraceptive pills, Progesterone-only pill, depo-provera, oral provera, progesterone-containing intrauterine contraceptive device
Insulin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to examine how semaglutide affects women with Polycystic Ovarian Syndrome (PCOS) and if it can provide any therapeutic benefits.

Who is the study for?
This trial is for women aged 18-45 with a BMI over 30 who have been diagnosed with Polycystic Ovarian Syndrome (PCOS). Participants must have normal levels of certain hormones. Women using hormone-based contraceptives, fertility drugs, insulin, or those who've had a hysterectomy or endometrial ablation cannot join.
What is being tested?
The study is looking at the effects of Semaglutide on women with PCOS to see if it can be an effective treatment. It's not clear how many groups there are or if there will be comparisons to other treatments.
What are the potential side effects?
Semaglutide may cause digestive issues like nausea and diarrhea, potential low blood sugar events in people taking insulin, increased heart rate, and possible inflammation of the pancreas.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 45 years old.
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I have been diagnosed with PCOS.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not using any hormone-based birth control methods.
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I take insulin for my diabetes.
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I have had a hysterectomy.
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I have undergone a procedure to remove the lining of my uterus.
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I am taking medication that blocks male hormones.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of appropriate weekly dose
Number of days on therapy
Secondary study objectives
Numbers of days with exercise changes
measure the Weight in kilograms

Side effects data

From 2020 Phase 4 trial • 104 Patients • NCT04189848
21%
Nausea
12%
Decreased Appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Study

Awards & Highlights

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: Protocol groupExperimental Treatment1 Intervention
PCOS women in the age 18 to 45 years
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
2021
Completed Phase 4
~5160

Find a Location

Who is running the clinical trial?

Methodist Health SystemLead Sponsor
155 Previous Clinical Trials
4,825,461 Total Patients Enrolled
~57 spots leftby Jan 2026
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