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NCT06222437 Clinical Trial

Semaglutide and Polycystic Ovarian Syndrome: an Emerging Treatment Strategy

Polycystic Ovary Syndrome Clinical Trial

Official title:
Semaglutide and Polycystic Ovarian Syndrome: an Emerging Treatment Strategy

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06222437
Other study ID # 046.OBG.2023.D
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date January 2025
Est. completion date January 2026

Study information
Verified date March 2024
Source Methodist Health System
Contact Bethany Brauer
Phone 214-947-4681
Email mhsirb@mhd.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effect of semaglutide in women with Polycystic Ovarian Syndrome(PCOS ) and determine potential therapeutic benefits.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 85
Est. completion date January 2026
Est. primary completion date January 2026
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 - 5a reductase inhibitors - Insulin - Hysterectomy - Endometrial ablation

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Semaglutide
effectiveness of semaglutide in PCOS

Locations
Country Name City State
United States Clinical Research Institute at Methodist Health System Dallas Texas

Sponsors (1)
Lead Sponsor Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of appropriate weekly dose To access the compliances of the therapy 4 weeks
Primary Number of days on therapy To access the persistence on Semaglutide 4 weeks
Secondary measure the Weight in kilograms To access the weight changes during therapy 4 weeks
Secondary Numbers of days with exercise changes To access the ability to do exercise during the therapy 4 weeks
See also
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Completed NCT06158932 - A Single Group Study to Evaluate the Effects of a Myo-Inositol and D-Chiro Inositol Supplement on Symptoms Associated With Polycystic Ovary Syndrome and Hormone Imbalance N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Active, not recruiting NCT02500147 - Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS) Phase 4
Completed NCT04932070 - Berberine and Polycystic Ovary Syndrome N/A
Suspended NCT03652987 - Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS)
Completed NCT03480022 - Liraglutide 3mg (Saxenda) on Weight, Body Composition, Hormonal and Metabolic Parameters in Obese Women With PCOS Phase 3
Active, not recruiting NCT03043924 - Functional Study of the Hypothalamus in Magnetic Resonance Imaging (MRI) in Polycystic Ovary Syndrome (PCOS) N/A
Completed NCT05246306 - Aerobic Capacity and Physical Fitness Level of Adolescents With PCOS
Completed NCT05981742 - Effects of Combined Metformin and Cabergoline in Comparison With Metformin Only Therapy on Ovarian and Hormonal Activities in Iraqi Patients With PCOS Phase 2
Completed NCT05702957 - Letrozole vs Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovarian Syndrome Phase 2/Phase 3
Completed NCT05029492 - Effect of Visceral Manipulation on PCOS N/A
Not yet recruiting NCT02255578 - Endobarrier Treatment in Women With PCOS Phase 3
Completed NCT02924025 - Motivational Interviewing as an Intervention for PCOS N/A
Completed NCT02098668 - Mathematical Model for the Human Menstrual Cycle, Endocrinological Diseases and Fertility Treatment-PAEON N/A
Not yet recruiting NCT00883259 - Metformin and Gestational Diabetes in High-risk Patients: a RCTs Phase 4
Withdrawn NCT01638988 - Clomifene Citrate Versus Metformin in First-line Treatment of Infertility in Patients With Polycystic Ovary Syndrome and a Resistance to Insulin Phase 3
Completed NCT01462864 - Development of a Structured Education Programme for Women With Polycystic Ovary Syndrome N/A
Recruiting NCT01431352 - Letrozole Versus Chinese Herbal Medicine on Polycystic Ovary Syndrome (PCOS) N/A
Completed NCT00989781 - Mechanisms of Increased Androgen Production Among Women With Polycystic Ovary Syndrome N/A