Efficacy of Vildagliptin Versus Metformin in Poly Cystic Ovary Syndrome

• Sponsor: October 6 University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06142656
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 5.2
• Patients Per Site Per Month: 11.6

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Poly Cystic Ovary Syndrome	Drug: Metformin Hydrochloride tablet; Drug: Vildagliptin 50 MG	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Efficacy of Vildagliptin Versus Metformin in Poly Cystic Ovary Syndrome: A Randomized Clinical Trial
• Actual Study Start Date: Nov 25, 2023
• Anticipated Primary Completion Date: Apr 1, 2024
• Anticipated Study Completion Date: May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Metformin	Drug: Metformin Hydrochloride tablet; Metformin Hydrochloride 850 mg oral tablet
Active Comparator: Vildagliptin	Drug: Vildagliptin 50 MG; Vildagliptin 50 MG oral tablets

Outcome Measures

Primary Outcome Measures

1. Concentration of luteinizing hormone (LH) [at baseline and after 3 months]

   serum luteinizing hormone (LH)

2. Concentration of Follicle-stimulating hormone [at baseline and after 3 months]

   Serum Follicle-stimulating hormone

3. Concentration of Free androgen index [at baseline and after 3 months]

   serum Free androgen index

4. Concentration of total testosterone [at baseline and after 3 months]

   serum total testosterone

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	October 6 university hospital	Giza		Egypt	12585

Sponsors and Collaborators

• October 6 University

Investigators

• Principal Investigator: ahmed hussein, PhD, october 6 university hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: engy wahsh, LECTURER OF CLINICAL PHARMACY, October 6 University
• ClinicalTrials.gov Identifier: NCT06142656
• Other Study ID Numbers: PRC-Ph-2307004
• First Posted: Nov 21, 2023
• Last Update Posted: Nov 29, 2023
• Last Verified: Nov 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Ovarian Cysts; Syndrome; Metformin; Vildagliptin

Study Results

No Results Posted as of Nov 29, 2023