search
Back to results

Effect of Liraglutide in Obese Women With Polycystic Ovary Syndrome

Primary Purpose

Polycystic Ovary

Status
Not yet recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
liraglutide
Metformin
Sponsored by
Beni-Suef University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary focused on measuring polycystic ovary, liraglutide

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: aged between 20 and 45 years PCO Exclusion Criteria: 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

Sites / Locations

  • Beni-suef university Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

liraglutide

metformin

control

Arm Description

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

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

not given any drug

Outcomes

Primary Outcome Measures

Body weight loss
basal body weight - body weight reached after treatment

Secondary Outcome Measures

Full Information

First Posted
July 20, 2023
Last Updated
July 28, 2023
Sponsor
Beni-Suef University
search

1. Study Identification

Unique Protocol Identification Number
NCT05965908
Brief Title
Effect of Liraglutide in Obese Women With Polycystic Ovary Syndrome
Official Title
Effect of Liraglutide on Different Parameters (Clinical , Metabolic and Hormonal) in Obese Women With Polycystic Ovary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 30, 2023 (Anticipated)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beni-Suef University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary
Keywords
polycystic ovary, liraglutide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
liraglutide
Arm Type
Experimental
Arm Description
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
Arm Title
metformin
Arm Type
Active Comparator
Arm Description
the patient is given Glucophage 1000 mg tab once daily after lunch for 1month
Arm Title
control
Arm Type
No Intervention
Arm Description
not given any drug
Intervention Type
Drug
Intervention Name(s)
liraglutide
Other Intervention Name(s)
saxenda ampoules
Intervention Description
glucagon-like peptide 1 receptor agonist
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
Glucophage 1000mg
Intervention Description
biguanide antihyperglycemic
Primary Outcome Measure Information:
Title
Body weight loss
Description
basal body weight - body weight reached after treatment
Time Frame
1 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: aged between 20 and 45 years PCO Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara A Salem, MD
Phone
01272842226
Ext
02
Email
sara_abdallah100@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beni-Suef University
Organizational Affiliation
Clinical Pharmacy Faculty of Pharmacy Beni-Suef University
Official's Role
Study Director
Facility Information:
Facility Name
Beni-suef university Hospital
City
Banī Suwayf
State/Province
Beni Suef
ZIP/Postal Code
62521
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
all collected data

Learn more about this trial

Effect of Liraglutide in Obese Women With Polycystic Ovary Syndrome

We'll reach out to this number within 24 hrs