Semaglutide and Polycystic Ovarian Syndrome: an Emerging Treatment Strategy

Methodist Health System

Status and phase: Not yet enrolling; Phase 1

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: Semaglutide

Study type: Interventional

Funder types: Other

Identifiers

NCT06222437

046.OBG.2023.D

Details and patient eligibility

About

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

Full 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.

Enrollment: 85 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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85 participants in 1 patient group

Protocol group

Experimental group

Description:

PCOS women in the age 18 to 45 years

Treatment:

Drug: Semaglutide