Efficacy of Vildagliptin Versus Metformin in Patients With Polycystic Ovary Syndrome

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorTanta University

About this trial

Polycystic ovary syndrome (PCOS) is a common endocrine and metabolic disorder characterized by hyperandrogenism, ovulatory dysfunction, and polycystic ovarian morphology, with insulin resistance playing a central role in its pathophysiology. Hyperinsulinemia can enhance ovarian androgen production and reduce hepatic sex hormone-binding globulin synthesis, thereby aggravating hyperandrogenism and reproductive abnormalities. Vildagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, enhances endogenous incretin activity and may improve insulin sensitivity and glucose homeostasis. Emerging evidence suggests that DPP-4 inhibition may also influence body weight, androgen excess, inflammation, and reproductive function in women with PCOS.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Metformin

    Drug

    Metformin is a widely used insulin-sensitizing agent and one of the most established pharmacological treatments for the metabolic abnormalities associated with polycystic ovary syndrome

  • Vildagliptin (Galvus)

    Drug

    Vildagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, enhances endogenous incretin activity and may improve insulin sensitivity and glucose homeostasis.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Metformin groupActive comparator 1 intervention
Group B: Vildagliptin groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Fertility parameters-Follicle-stimulating hormone

Measurement of Follicle-stimulating hormone

Time frame
3-months
2

Fertility parameters- Luteinizing hormone

Measurement of Luteinizing hormone (LH)

Time frame
3 months
3

Fertility parameters-Free androgen index

mesurement of Free androgen index

Time frame
3-months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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