Semaglutide and Polycystic Ovarian Syndrome: an Emerging Treatment Strategy

NCT ID: NCT06222437

Last Updated: 2024-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-31

Study Completion Date

2026-01-31

Brief Summary

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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

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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.

Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Protocol group

PCOS women in the age 18 to 45 years

Group Type EXPERIMENTAL

Semaglutide

Intervention Type DRUG

effectiveness of semaglutide in PCOS

Interventions

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Semaglutide

effectiveness of semaglutide in PCOS

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Methodist Health System

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinical Research Institute at Methodist Health System

Dallas, Texas, United States

Site Status

Countries

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United States

Central Contacts

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Bethany Brauer

Role: CONTACT

214-947-4681 ext. 74681

Colette N Ndjom

Role: CONTACT

214-947-1289 ext. 71289

Facility Contacts

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Bethany N Brauer

Role: primary

410-947-4681 ext. 74681

Colette N Ndjom

Role: backup

214-947-1289 ext. 71289

Other Identifiers

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046.OBG.2023.D

Identifier Type: -

Identifier Source: org_study_id

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