Efficacy of Vildagliptin Versus Metformin in Poly Cystic Ovary Syndrome

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

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06142656

Enrollment

Registered

2023-11-21

Start date

2023-11-25

Completion date

2026-02-01

Last updated

2025-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Poly Cystic Ovary Syndrome

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

Interventions

DRUGMetformin Hydrochloride tablet

Metformin Hydrochloride 850 mg oral tablet

DRUGVildagliptin 50 MG

Vildagliptin 50 MG oral tablets

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Egypt

Contacts

Primary Contactahmed hussein, phD

ahmedhussein.med@o6u.edu.eg01001749605

Backup Contactahmed hussein

ahmedhussein.med@o6u.edu.eg

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026