Efficacy of Vildagliptin Versus Metformin in Poly Cystic Ovary Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Metformin Hydrochloride tablet, Vildagliptin 50 MG.
- Who it may be relevant to
- Registry conditions: Poly Cystic Ovary Syndrome. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Vildagliptin Versus Metformin in Poly Cystic Ovary Syndrome: A Randomized Clinical Trial
Overview
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
Interventions
- Drug Metformin Hydrochloride tablet
Metformin Hydrochloride 850 mg oral tablet - Drug Vildagliptin 50 MG
Vildagliptin 50 MG oral tablets
Primary outcome measures
- Concentration of luteinizing hormone (LH) [Time frame: at baseline and after 3 months]
- Concentration of Follicle-stimulating hormone [Time frame: at baseline and after 3 months]
- Concentration of Free androgen index [Time frame: at baseline and after 3 months]
- Concentration of total testosterone [Time frame: at baseline and after 3 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- October 6 university hospital — Giza
Identifiers
NCT: NCT06142656 · PRC-Ph-2307004