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Effect of Sitagliptin on Polycystic Ovarian Syndrome Patients

Sponsor
Beni-Suef University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05972928
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
3
Anticipated Duration (Months)
26.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The Study aims to determine the proposed positive influence of Sitagliptin in manipulating hormonal , metabolic and inflammatory parameters in the treatment of Polycystic ovary syndrome and subsequent infertility

Condition or Disease Intervention/Treatment Phase
  • Drug: Sitagliptin 100mg
 Phase 2/Phase 3

Detailed Description

Study Design : a Prospective Randomized Controlled Trial.

A Total of 80 infertile Adult Females aged between 18 and 45 years currently diagnosed with Polycystic ovary syndrome , Meeting the Diagnosis of Rotterdam criteria be diagnosed if any two of the following are present: (1) clinical or biochemical hyperandrogenism, (2) evidence of oligo-anovulation, (3) polycystic appearing-ovarian morphology on ultrasound are to be included in the study.

The study will include two groups; each group consists of 40 patients:- Group A : Control Group Group B : Test Group ( will Receive Sitagliptin at a dose of 100 mg every 24 hours

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Sitagliptin on Clinical, Metabolic and Hormonal Parameters in Polycystic Ovarian Syndrome Patients
Anticipated Study Start Date :
Jul 30, 2023
Anticipated Primary Completion Date :
Oct 30, 2023
Anticipated Study Completion Date :
Oct 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sitagliptin

Sitagliptin at a dose of 100 mg every 24 hours for 3 months

Drug: Sitagliptin 100mg
Sitagliptin at a dose of 100 mg every 24 hours for 3 months
Other Names:
  • Januvia 100 mg tab

    		•
    No Intervention: control

    patient won't receive medication

    Outcome Measures

    Primary Outcome Measures

    1. Body weight loss in Kilograms [3 months]

      Body weight before - Body weight after

    Eligibility Criteria

    Criteria

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

    polycystic ovary syndrome usually diagnosed based on the Rotterdam criteria if 2 of 3 criteria are present:

    1. oligo- and/or anovulation

    2. hyperandrogenism (HA) (clinical and/or biochemical)

    3. polycystic ovary morphology (PCOM) on ultrasonography (either 12 or more follicles measuring 2-9 mm in diameter and/or an increased ovarian volume >10 cm3).

    Exclusion Criteria:

    1. congenital adrenal hyperplasia

    2. Brittle control of a thyroid disorder

    3. Diabetic on Metformin or any another antidiabetic drugs affecting insulin resistance

    4. chronic kidney disease

    5. liver dysfunction

    6. documented use of oral hormonal contraceptives and hormone-releasing implants in the past 6 months prior to study entry 7.Lipid lowering Consumption

    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

    None specified.

    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:
    NCT05972928
    Other Study ID Numbers:
    • Sitagliptin PCO
    First Posted:
    Aug 2, 2023
    Last Update Posted:
    Aug 2, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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 Syndrome
    Sitagliptin
    Additional relevant MeSH terms:
    Polycystic Ovary Syndrome
    Syndrome
    Sitagliptin Phosphate

    Study Results

    No Results Posted as of Aug 2, 2023