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Effect of Liraglutide in Obese Women With Polycystic Ovary Syndrome

Sponsor
Beni-Suef University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05965908
Collaborator
(none)
120
Enrollment
1
Location
3
Arms
3
Anticipated Duration (Months)
39.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Liraglutide on Different Parameters (Clinical , Metabolic and Hormonal) in Obese Women With Polycystic Ovary Syndrome
Anticipated Study Start Date :
Jul 30, 2023
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Oct 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: liraglutide

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
glucagon-like peptide 1 receptor agonist
Other Names:
  • saxenda ampoules

    		•
    Active Comparator: metformin

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

    Drug: Metformin
    biguanide antihyperglycemic
    Other Names:
  • Glucophage 1000mg

    		•
    No Intervention: control

    not given any drug

    Outcome Measures

    Primary Outcome Measures

    1. Body weight loss [1 months]

      basal body weight - body weight reached after treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beni-suef university Hospital Banī Suwayf Beni Suef Egypt 62521

    Sponsors and Collaborators

    • Beni-Suef University

    Investigators

    • Study Director: Beni-Suef University, Clinical Pharmacy Faculty of Pharmacy Beni-Suef University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sara Abdallah Mohamed Salem, Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University, Beni-Suef University
    ClinicalTrials.gov Identifier:
    NCT05965908
    Other Study ID Numbers:
    • Liraglutide Polycystic Ovary
    First Posted:
    Jul 28, 2023
    Last Update Posted:
    Aug 1, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sara Abdallah Mohamed Salem, Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University, Beni-Suef University
    polycystic ovary
    liraglutide
    Additional relevant MeSH terms:
    Polycystic Ovary Syndrome
    Metformin
    Liraglutide

    Study Results

    No Results Posted as of Aug 1, 2023