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Effect of Sitagliptin on Polycystic Ovarian Syndrome Patients

Primary Purpose

Polycystic Ovary Syndrome

Status
Not yet recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Sitagliptin 100mg
Sponsored by
Beni-Suef University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Polycystic Ovary Syndrome, Sitagliptin

Eligibility Criteria

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

Inclusion Criteria: polycystic ovary syndrome usually diagnosed based on the Rotterdam criteria if 2 of 3 criteria are present: oligo- and/or anovulation hyperandrogenism (HA) (clinical and/or biochemical) 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: congenital adrenal hyperplasia Brittle control of a thyroid disorder Diabetic on Metformin or any another antidiabetic drugs affecting insulin resistance chronic kidney disease liver dysfunction documented use of oral hormonal contraceptives and hormone-releasing implants in the past 6 months prior to study entry 7.Lipid lowering Consumption

Sites / Locations

  • Beni-suef university Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Sitagliptin

control

Arm Description

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

patient won't receive medication

Outcomes

Primary Outcome Measures

Body weight loss in Kilograms
Body weight before - Body weight after

Secondary Outcome Measures

Full Information

First Posted
July 25, 2023
Last Updated
August 1, 2023
Sponsor
Beni-Suef University
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1. Study Identification

Unique Protocol Identification Number
NCT05972928
Brief Title
Effect of Sitagliptin on Polycystic Ovarian Syndrome Patients
Official Title
Effect of Sitagliptin on Clinical, Metabolic and Hormonal Parameters in Polycystic Ovarian Syndrome Patients
Study Type
Interventional

2. Study Status

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
Polycystic Ovary Syndrome, Sitagliptin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sitagliptin
Arm Type
Experimental
Arm Description
Sitagliptin at a dose of 100 mg every 24 hours for 3 months
Arm Title
control
Arm Type
No Intervention
Arm Description
patient won't receive medication
Intervention Type
Drug
Intervention Name(s)
Sitagliptin 100mg
Other Intervention Name(s)
Januvia 100 mg tab
Intervention Description
Sitagliptin at a dose of 100 mg every 24 hours for 3 months
Primary Outcome Measure Information:
Title
Body weight loss in Kilograms
Description
Body weight before - Body weight after
Time Frame
3 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: polycystic ovary syndrome usually diagnosed based on the Rotterdam criteria if 2 of 3 criteria are present: oligo- and/or anovulation hyperandrogenism (HA) (clinical and/or biochemical) 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: congenital adrenal hyperplasia Brittle control of a thyroid disorder Diabetic on Metformin or any another antidiabetic drugs affecting insulin resistance chronic kidney disease liver dysfunction documented use of oral hormonal contraceptives and hormone-releasing implants in the past 6 months prior to study entry 7.Lipid lowering Consumption
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beni-suef University
Phone
082 2318605
Ext
02
Email
fom@med.bsu.edu.eg
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
Undecided

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Effect of Sitagliptin on Polycystic Ovarian Syndrome Patients

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