Effect of Liraglutide in Obese Women With Polycystic Ovary Syndrome

Polycystic Ovary Clinical Trial

Official title:

Effect of Liraglutide on Different Parameters (Clinical , Metabolic and Hormonal) in Obese Women With Polycystic Ovary Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05965908
• Other study ID #: Liraglutide Polycystic Ovary
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: July 30, 2023
• Est. completion date: October 30, 2023

Study information

• Verified date: July 2023
• Source: Beni-Suef University
• Contact: Sara A Salem, MD
• Phone: 01272842226
• Email: sara_abdallah100[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

It is a Prospective randomized controlled trial .The study will include 80 randomly selected infertile women aged between 18 and 45 years, from Gynecology and obstetrics department Beni-Suef University Hospital whom diagnosed with polycystic ovarian syndrome (PCOS), The study will include two groups; each group consists of 40 patients:-

• Group1 (n=40) will be treated by liraglutide monotherapy.

• Group 2 (n=40) will be treated by metformin monotherapy.

• Group 3 (n=40) will be a control group.

To assess the metabolic effect of each treatment, the following parameters will be assessed before and after the treatment

• To assess the hormonal effect of each treatment, the following tests will be assessed before and after treatment

• Total Testosterone (TT)

• Dehydroepiandrosterone (DHEA)

To assess the clinical effect of the drugs, the following will be assessed before and after treatment:

The number of medium size follicles and large size follicles and the endometrium thickness were assessed on the tenth or eleventh day of menstruation. The chemical and clinical pregnancy rates were evaluated

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: October 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• aged between 20 and 45 years

• PCO

Exclusion Criteria:

1. congenital adrenal hyperplasia

2. poorly controlled thyroid disease

3. Taking antidiabetic drugs which can affect insulin resistance

4. chronic kidney disease and history of recurrent urinary tract infections

5. liver dysfunction

6. documented use of oral hormonal contraceptives and hormone-releasing implants

Related Conditions & MeSH terms

• Polycystic Ovary
• Polycystic Ovary Syndrome

Intervention

Drug:
• liraglutide
glucagon-like peptide 1 receptor agonist
• Metformin
biguanide antihyperglycemic

Locations

Country	Name	City	State
Egypt	Beni-suef university Hospital	Bani Suwayf	Beni Suef

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight loss	basal body weight - body weight reached after treatment	1 months