Effect of Sitagliptin on Polycystic Ovarian Syndrome Patients
Effect of Sitagliptin on Clinical, Metabolic and Hormonal Parameters in Polycystic Ovarian Syndrome Patients
1 other identifier
interventional
80
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2023
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2023
CompletedStudy Start
First participant enrolled
July 30, 2023
CompletedFirst Posted
Study publicly available on registry
August 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2023
CompletedAugust 2, 2023
August 1, 2023
3 months
July 25, 2023
August 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Body weight loss in Kilograms
Body weight before - Body weight after
3 months
Study Arms (2)
Sitagliptin
EXPERIMENTALSitagliptin at a dose of 100 mg every 24 hours for 3 months
control
NO INTERVENTIONpatient won't receive medication
Interventions
Sitagliptin at a dose of 100 mg every 24 hours for 3 months
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beni-suef university Hospital
Banī Suwayf, Beni Suweif Governorate, 62521, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University
Study Record Dates
First Submitted
July 25, 2023
First Posted
August 2, 2023
Study Start
July 30, 2023
Primary Completion
October 30, 2023
Study Completion
October 30, 2023
Last Updated
August 2, 2023
Record last verified: 2023-08