Efficacy of Vildagliptin Versus Metformin in Poly Cystic Ovary Syndrome

Efficacy of Vildagliptin Versus Metformin in Poly Cystic Ovary Syndrome: A Randomized Clinical Trial

Polycystic ovary syndrome (PCOS) is an endocrine disorder that affects approximately 10-20% of women of reproductive age, Management strategies for PCOS include lifestyle modifications such as diet and physical activity that are the first-line approach to treatment; however, they are reported to be minimally effective in reducing weight or treating PCOS-related symptoms.Pharmacological options are also available; however, they are not explicitly approved for PCOS treatment as they have been primarily used to treat other conditions such as T2DM

Study Overview

• Status: Recruiting
• Conditions: Poly Cystic Ovary Syndrome
• Intervention / Treatment: Drug: Metformin Hydrochloride tablet; Drug: Vildagliptin 50 MG

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: ahmed hussein; Email: ahmedhussein.med@o6u.edu.eg
• Study Contact Backup: Name: ahmed hussein, phD; Phone Number: 01001749605; Email: ahmedhussein.med@o6u.edu.eg

Study Locations

• Egypt
  • Giza, Egypt, 12585
    • Recruiting
    • October 6 university hospital
    • Contact: ahmed M. A, phD; Phone Number: 01001749605
    • Contact: Hanan elhanafy; Phone Number: 01281084864

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

-Women diagnosed with PCOS according to Rotterdam 2003 criteria National Institute of Health criteria.

Exclusion Criteria:

• Patients with history of diabetes mellitus (Type 1 or 2).
• Patients with liver or renal dysfunction; inflammatory diseases; autoimmune disease; cancer, acute cardiovascular event within last three months
• Known hypersensitivity or contraindications to use dipeptidyl peptidase-4 (DPP-4) inhibitors
• Eating disorders (anorexia, bulimia) or gastrointestinal disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Metformin	Drug: Metformin Hydrochloride tablet; Metformin Hydrochloride 850 mg oral tablet
Active Comparator: Vildagliptin	Drug: Vildagliptin 50 MG; Vildagliptin 50 MG oral tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of luteinizing hormone (LH)	serum luteinizing hormone (LH)	at baseline and after 3 months
Concentration of Follicle-stimulating hormone	Serum Follicle-stimulating hormone	at baseline and after 3 months
Concentration of Free androgen index	serum Free androgen index	at baseline and after 3 months
Concentration of total testosterone	serum total testosterone	at baseline and after 3 months

Collaborators and Investigators

• Sponsor: October 6 University
• Investigators: Principal Investigator: ahmed hussein, PhD, October 6 university hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: November 13, 2023
• First Submitted That Met QC Criteria: November 16, 2023
• First Posted (Actual): November 21, 2023

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 26, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Syndrome; Ovarian Cysts; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Dipeptidyl-Peptidase IV Inhibitors; Metformin; Vildagliptin
• Other Study ID Numbers: PRC-Ph-2307004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No