Efficacy of Vildagliptin Versus Metformin in Poly Cystic Ovary Syndrome

NCT06142656 | Recruiting Phase 2

• 1 other identifier: PRC-Ph-2307004
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Poly Cystic Ovary Syndrome

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Metformin

ACTIVE COMPARATOR

Drug: Metformin Hydrochloride tablet

Vildagliptin

ACTIVE COMPARATOR

Drug: Vildagliptin 50 MG

Interventions

Metformin Hydrochloride tablet DRUG

Metformin Hydrochloride 850 mg oral tablet

Metformin

Vildagliptin 50 MG DRUG

Vildagliptin 50 MG oral tablets

Vildagliptin

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• October 6 University: lead

Study Sites (1)

October 6 university hospital

Giza, 12585, Egypt

RECRUITING

MeSH Terms

Interventions

Metformin; Vildagliptin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Nitriles; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• ahmed hussein, PhD

  october 6 university hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ahmed hussein, phD

CONTACT

01001749605; ahmedhussein.med@o6u.edu.eg

ahmed hussein

CONTACT

ahmedhussein.med@o6u.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: LECTURER OF CLINICAL PHARMACY

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 21, 2023
• Study Start: November 25, 2023
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-07

Locations

EG (1)