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GLP-1 Receptor Agonist

Protocol group 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am between 18 and 45 years old.
Select...
I have been diagnosed with PCOS.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of appropriate weekly dose
Number of days on therapy
Secondary outcome measures
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

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
2019
Completed Phase 4
~5160

Find a Location

Who is running the clinical trial?

Methodist Health SystemLead Sponsor
152 Previous Clinical Trials
4,825,548 Total Patients Enrolled

Frequently Asked Questions

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

Are there any ongoing opportunities for patients to participate in this clinical trial at the moment?

"Indeed, as per clinicaltrials.gov, this study is actively seeking eligible participants. The trial was originally published on December 1st, 2023 and underwent its latest revision on January 16th, 2024."

Answered by AI

What is the level of safety provided by Protocol group for individuals undergoing medical treatment?

"Based on its Phase 1 nature, the Protocol group is assigned a safety rating of 1 since there is limited available data supporting both efficacy and safety."

Answered by AI

Is it feasible for me to participate in this clinical trial?

"Individuals who meet the eligibility criteria for this clinical trial should have a diagnosis of polycystic ovary syndrome and fall within the age range of 18 to 45 years. The study aims to enroll a total of 85 participants."

Answered by AI

What is the current number of participants being admitted into this clinical study?

"Indeed, the details on clinicaltrials.gov indicate that this study is currently seeking participants. The trial was initially posted on December 1st, 2023 and was most recently updated on January 16th, 2024. The research team aims to enroll a total of 85 patients from a single site."

Answered by AI

Is the clinical trial open to individuals who are below the age of 25?

"To be considered eligible for this research study, individuals must fall within the age range of 18 to 45. It is worth mentioning that there are currently 386 trials available for participants under the age of 18 and an additional 1026 trials specifically targeting individuals over the age of 65."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Clinical Research Institute at Methodist Health System

Why did patients apply to this trial?

I have tried all diets, metformin, etc and nothing is helping with my PCOS symptoms.
PatientReceived 1 prior treatment
I’ve struggled with my weight my whole life. Even with exercise and diet I cannot seem to achieve long lasting weight loss.
PatientReceived 1 prior treatment
I have tried diet, exercise, supplements, and fasting, and my weight continues to climb. My PCOS symptoms are not under control.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Semaglutide and Polycystic Ovarian Syndrome: an Emerging Treatment Strategy
2025. "Semaglutide and Polycystic Ovarian Syndrome: an Emerging Treatment Strategy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06222437.
All > Pcos > Fort Worth
~57 spots leftby Jan 2026
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