Efficacy of Vildagliptin Versus Metformin in Poly Cystic Ovary Syndrome

October 6 University

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Poly Cystic Ovary Syndrome

Treatments: Drug: Metformin Hydrochloride tablet; Drug: Vildagliptin 50 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT06142656

PRC-Ph-2307004

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Metformin

Active Comparator group

Treatment:

Drug: Metformin Hydrochloride tablet

Vildagliptin

Active Comparator group

Treatment:

Drug: Vildagliptin 50 MG