Efficacy of Vildagliptin Versus Metformin in Poly Cystic Ovary Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-25

Study Completion Date

2026-02-01

Brief Summary

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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

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Detailed Description

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Conditions

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Poly Cystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Metformin

Group Type ACTIVE_COMPARATOR

Metformin Hydrochloride tablet

Intervention Type DRUG

Metformin Hydrochloride 850 mg oral tablet

Vildagliptin

Group Type ACTIVE_COMPARATOR

Vildagliptin 50 MG

Intervention Type DRUG

Vildagliptin 50 MG oral tablets

Interventions

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Metformin Hydrochloride tablet

Metformin Hydrochloride 850 mg oral tablet

Intervention Type DRUG

Vildagliptin 50 MG

Vildagliptin 50 MG oral tablets

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No