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of Sodium Glucose Cotransporter-2 Inhibitors on Metabolic, Hormonal and Clinical Parameters in PCO

Sponsor
Beni-Suef University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05601336
Collaborator
(none)
200
Enrollment
1
Location
4
Arms
18.4
Anticipated Duration (Months)
10.9
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 dapagliflozin as monotherapies and the effect of both of them as a combined therapy 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 200 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), according to Rotterdam criteria (BMI≥ 24kg/m, Homeostatic model assessment of insulin resistance (HOMA-IR with cutoff ≥ 2.5 biochemical hyperandrogenism, as indicated by a free androgen index (FAI) >4, and self-reported oligomenorrhea (cycle length >35 days and 9 or fewer periods per year) or amenorrhoea (absence of menses for a period ≥3 months) will be included for the study.

I The study will include four groups; each group consists of 50 patients:-

  • Group I (n=50) will be treated by metformin monotherapy.

  • Group II (n=50) will be treated by Dapagliflozin monotherapy .

  • Group III (n=50) will be treated by metformin and dapagliflozin combined therapy

  • Group IV (n=50) will be a control group.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Sodium Glucose Cotransporter-2 Inhibitors on Metabolic, Hormonal and Clinical Parameters in Infertile Women With Polycystic Ovary Syndrome
Actual Study Start Date :
Jan 15, 2022
Anticipated Primary Completion Date :
Apr 30, 2023
Anticipated Study Completion Date :
Jul 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: metformin monotherapy

Glucophage 1000 once daily

Drug: Metformin Hydrochloride 1000 MG
metformin
Other Names:
  • Glucophage 1000mg

    		•
    Active Comparator: Dapagliflozin monotherapy .

    Farxiga once per day

    Drug: Dapagliflozin 5 MG
    SGLT2 inhibitor
    Other Names:
  • [Farxiga]

    		•
    Active Comparator: metformin and dapagliflozin combined therapy

    Xigduo once daily

    Drug: Dapagliflozin/Metformin
    SGLT2 inhibitor and metformin HCl extended-release
    Other Names:
  • Xigduo

    		•
    No Intervention: control group.

    placebo

    Outcome Measures

    Primary Outcome Measures

    1. ovulation1 [1st cycle /28days]

      folliculometry by ultrasound

    2. Cummulative rate of pregnancy [3 months]

      HCG test

    3. ovulation 2 [2nd cycle/28 days]

      folliculometry by ultrasound

    Secondary Outcome Measures

    1. Body weight changes [3 months]

      weight loss by Kg

    2. changes of Menstrual cycle [3 months]

      history from the patient

    3. Fasting blood sugar (FBS)/ 2 hpp [3 months]

    4. Free Androgen Index (FAI) [3 months]

    5. Total Testosterone (TT) [3 months]

    6. FSH*LH*E2 [3 months]

    7. lipid profile [3 months]

    8. ALT [3 months]

    9. side effects [3 months]

      Number of patients will report nausea / diarrhea/ lactic acidosis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Women are aged between 18 and 45 years

    • no pregnancy plan within the next 6 months

    • polycystic ovarian syndrome (PCOS), according to Rotterdam criteria

    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 (AST or ALT > 3 times the upper limit of normal or GFR<30 ml/min/1.73m2)

    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 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:
    NCT05601336
    Other Study ID Numbers:
    • REC-H-PhBSU-22012
    First Posted:
    Nov 1, 2022
    Last Update Posted:
    Nov 1, 2022
    Last Verified:
    Oct 1, 2022
    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
    Additional relevant MeSH terms:
    Metformin
    Dapagliflozin

    Study Results

    No Results Posted as of Nov 1, 2022