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NCT Number: NCT06142656

Efficacy of Vildagliptin Versus Metformin in Poly Cystic Ovary Syndrome

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

Recruiting

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Key information

Conditions

Poly Cystic Ovary Syndrome

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

October 6 university hospital

Giza, 12585, Egypt

Location status: Recruiting

Location contact

Hanan elhanafy

CONTACT

01281084864

ahmed M. A, phD

CONTACT

01001749605

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metformin Hydrochloride tablet

Drug

Metformin Hydrochloride 850 mg oral tablet

Vildagliptin 50 mg

Drug

Vildagliptin 50 MG oral tablets

Primary outcomes

  1. Concentration of luteinizing hormone (LH)

    Time frame: at baseline and after 3 months

    serum luteinizing hormone (LH)

  2. Concentration of Follicle-stimulating hormone

    Time frame: at baseline and after 3 months

    Serum Follicle-stimulating hormone

  3. Concentration of Free androgen index

    Time frame: at baseline and after 3 months

    serum Free androgen index

  4. Concentration of total testosterone

    Time frame: at baseline and after 3 months

    serum total testosterone

Study contacts

Contact information is provided by the study sponsor or research team.

ahmed hussein

CONTACT

[email protected]

ahmed hussein, phD

CONTACT

[email protected]

01001749605

Sponsors and collaborators

Lead sponsor

October 6 University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Nov 21, 2023
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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