Efficacy of Vildagliptin Versus Metformin in Poly Cystic Ovary Syndrome

Phase 2

Recruiting

• Conditions: Poly Cystic Ovary Syndrome
• Interventions: Drug: Metformin Hydrochloride tablet; Drug: Vildagliptin 50 MG

• Registration Number: NCT06142656
• Lead Sponsor: October 6 University

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-13
• Study First Submitted QC: 2023-11-16
• Study First Posted: 2023-11-21
• Study Start: 2023-11-25
• Last Update Submitted: 2023-11-26
• Last Update Posted: 2023-11-29
• Primary Completion: 2024-04-01
• Study Completion: 2024-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin	Metformin Hydrochloride tablet	-
Vildagliptin	Vildagliptin 50 MG	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

October 6 university hospital; 🇪🇬 Giza, Egypt