Semaglutide and Polycystic Ovarian Syndrome: an Emerging Treatment Strategy

March 19, 2026 updated by: Methodist Health System
The purpose of this study is to investigate the effect of semaglutide in women with Polycystic Ovarian Syndrome(PCOS ) and determine potential therapeutic benefits.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The study mainly focused for the following objectives:

To determine the effect of semaglutide on ovulation and menstrual regularity. To determine the effect of semaglutide on androgen levels, namely testosterone, sex hormone binding globulin, and changes in hirsutism.

To determine changes in weight, body mass index (BMI), and Glycated Hemoglobin( HbA1c) with semaglutide therapy.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75203
        • Clinical Research Institute at Methodist Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18-45
  • Body mass index(BMI) > 30
  • Diagnosis of PCOS
  • Normal thyroid stimulating hormone, prolactin, follicle-stimulating hormone (FSH), estradiol, and normal progesterone

Exclusion Criteria:

  • Medications excluded: any hormone-containing contraceptive - oral contraceptive pills, Progesterone-only pill, depo-provera, oral provera, progesterone-containing intrauterine contraceptive device
  • Letrozole, clomiphene citrate, FSH therapy
  • Androgen receptor blockers
  • 5α reductase inhibitors
  • Insulin
  • Hysterectomy
  • Endometrial ablation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Protocol group
PCOS women in the age 18 to 45 years
Drug: Semaglutide
effectiveness of semaglutide in PCOS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of appropriate weekly dose
Time Frame: 4 weeks
To access the compliances of the therapy
4 weeks
Number of days on therapy
Time Frame: 4 weeks
To access the persistence on Semaglutide
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measure the Weight in kilograms
Time Frame: 4 weeks
To access the weight changes during therapy
4 weeks
Numbers of days with exercise changes
Time Frame: 4 weeks
To access the ability to do exercise during the therapy
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Methodist Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

January 16, 2024

First Submitted That Met QC Criteria

January 16, 2024

First Posted (Actual)

January 24, 2024

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 046.OBG.2023.D

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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