Semaglutide and Polycystic Ovarian Syndrome: an Emerging Treatment Strategy

Phase 1

Not yet recruiting

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: Semaglutide

• Registration Number: NCT06222437
• Lead Sponsor: Methodist Health System

Brief 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.

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 Timeline

• Study First Submitted: 2024-01-16
• Study First Submitted QC: 2024-01-16
• Study First Posted: 2024-01-24
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-27
• Study Start: 2025-01
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 85

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Protocol group	Semaglutide	PCOS women in the age 18 to 45 years

Primary Outcome Measures

Name	Time	Method
Number of appropriate weekly dose	4 weeks	To access the compliances of the therapy
Number of days on therapy	4 weeks	To access the persistence on Semaglutide

Secondary Outcome Measures

Name	Time	Method
measure the Weight in kilograms	4 weeks	To access the weight changes during therapy
Numbers of days with exercise changes	4 weeks	To access the ability to do exercise during the therapy

Trial Locations

Locations (1)

Clinical Research Institute at Methodist Health System; 🇺🇸 Dallas, Texas, United States