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RecruitingNCT06142656Updated Jul 30, 2025

Efficacy of Vildagliptin Versus Metformin in Poly Cystic Ovary Syndrome

A Phase 2/3 interventional study of Metformin Hydrochloride tablet and Vildagliptin 50 MG in Poly Cystic Ovary Syndrome, sponsored by October 6 University. Recruiting at 1 site in Egypt. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-07-30.

Sponsored by October 6 University · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Nov 2023; still recruiting 2 years 10 months later.
Phase
Phase 2/3
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
01

Study 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

02

Conditions studied

  • Poly Cystic Ovary Syndrome
03

In context

Lead sponsor

October 6 University is the lead sponsor of 135 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion 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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Metformin

    Drug: Metformin Hydrochloride tablet

  • Active comparator
    Vildagliptin

    Drug: Vildagliptin 50 MG

Interventions

  • DrugMetformin Hydrochloride tablet

    Metformin Hydrochloride 850 mg oral tablet

  • DrugVildagliptin 50 MG

    Vildagliptin 50 MG oral tablets

06

What researchers measure

Primary outcomes

  1. Concentration of luteinizing hormone (LH)

    serum luteinizing hormone (LH)

    Time frame: at baseline and after 3 months

  2. Concentration of Follicle-stimulating hormone

    Serum Follicle-stimulating hormone

    Time frame: at baseline and after 3 months

  3. Concentration of Free androgen index

    serum Free androgen index

    Time frame: at baseline and after 3 months

  4. Concentration of total testosterone

    serum total testosterone

    Time frame: at baseline and after 3 months

07

Study locations

1 of 1 sites recruiting
  • October 6 university hospital
    Giza, 12585, Egypt
    • ahmed M. A, phD · Contact · 01001749605
    • Hanan elhanafy · Contact · 01281084864
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06142656
Lead sponsor
October 6 University
Responsible party
engy wahsh (LECTURER OF CLINICAL PHARMACY, October 6 University) — Principal investigator
First posted
Nov 21, 2023
Start date
Nov 25, 2023
Primary completion
Dec 1, 2025 (estimated)
Completion
Feb 1, 2026 (estimated)
Last update
Jul 30, 2025

Study contacts

ahmed hussein, phD
Contact
ahmedhussein.med@o6u.edu.eg
01001749605
ahmed hussein
Contact
ahmedhussein.med@o6u.edu.eg
ahmed hussein, PhD
principal investigator · october 6 university hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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