Effect of Liraglutide in Obese Women With Polycystic Ovary Syndrome

NCT05965908 | Completed Phase 3

• 1 other identifier: Liraglutide Polycystic Ovary
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the hormonal, metabolic and clinical effects of metformin and liraglutide in infertile women with PCOs.

Conditions

Polycystic Ovary

Keywords

polycystic ovary; liraglutide

Outcome Measures

Primary Outcomes (1)

• Body weight loss

  basal body weight - body weight reached after treatment

  1 months

Study Arms (3)

liraglutide

EXPERIMENTAL

Saxenda® starting dose is 0.6 mg per day for 1 week.1. Patients increase the dose by 0.6 mg each week until the full maintenance dose of 3 mg is reached

Drug: liraglutide

metformin

ACTIVE COMPARATOR

the patient is given Glucophage 1000 mg tab once daily after lunch for 1month

Drug: Metformin

control

NO INTERVENTION

not given any drug

Interventions

liraglutide DRUG

glucagon-like peptide 1 receptor agonist

Also known as: saxenda ampoules

liraglutide

Metformin DRUG

biguanide antihyperglycemic

Also known as: Glucophage 1000mg

metformin

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• aged between 20 and 45 years
• PCO

You may not qualify if:

• congenital adrenal hyperplasia
• poorly controlled thyroid disease
• Taking antidiabetic drugs which can affect insulin resistance
• chronic kidney disease and history of recurrent urinary tract infections
• liver dysfunction
• documented use of oral hormonal contraceptives and hormone-releasing implants

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni-suef university Hospital

Banī Suwayf, Beni Suweif Governorate, 62521, Egypt

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Liraglutide; Metformin

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Beni-Suef University

  Clinical Pharmacy Faculty of Pharmacy Beni-Suef University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: July 28, 2023
• Study Start: January 30, 2024
• Primary Completion: March 30, 2025
• Study Completion: March 30, 2025
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

EG (1)