Efficacy of Vildagliptin Versus Metformin in Poly Cystic Ovary Syndrome

Poly Cystic Ovary Syndrome Clinical Trial

Official title:

Efficacy of Vildagliptin Versus Metformin in Poly Cystic Ovary Syndrome: A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06142656
• Other study ID #: PRC-Ph-2307004
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: November 25, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: November 2023
• Source: October 6 University
• Contact: ahmed hussein, phD
• Phone: 01001749605
• Email: ahmedhussein.med[@]o6u.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Ovarian Cysts
• Poly Cystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• Metformin Hydrochloride tablet
Metformin Hydrochloride 850 mg oral tablet
• Vildagliptin 50 MG
Vildagliptin 50 MG oral tablets

Locations

Country	Name	City	State
Egypt	October 6 university hospital	Giza

Sponsors (1)

Lead Sponsor	Collaborator
October 6 University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of luteinizing hormone (LH)	serum luteinizing hormone (LH)	at baseline and after 3 months
Primary	Concentration of Follicle-stimulating hormone	Serum Follicle-stimulating hormone	at baseline and after 3 months
Primary	Concentration of Free androgen index	serum Free androgen index	at baseline and after 3 months
Primary	Concentration of total testosterone	serum total testosterone	at baseline and after 3 months