Efficacy of Vildagliptin Versus Metformin in Poly Cystic... | NCT06142656

Studies
Efficacy of Vildagliptin Versus Metformin in Poly Cystic Ovary Syndrome

NCT06142656

Sponsor

October 6 University

Status

Recruiting

Last Update Posted

Jul 30, 2025Actual

Enrollment

60Estimated

Phase

Phase 2Phase 3

Conditions

Poly Cystic Ovary Syndrome

Interventions

Metformin Hydrochloride tablet
Vildagliptin 50 MG

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 25, 2023Actual

Primary Completion Date

Dec 1, 2025Estimated

Completion Date

Feb 1, 2026Estimated

First Submitted Date

Nov 13, 2023

First Submission Date that Met QC Criteria

Nov 16, 2023

First Posted Date

Nov 21, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 28, 2025

Last Update Posted Date

Jul 30, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Metformin	Active Comparator		Drug: Metformin Hydrochloride tablet
Vildagliptin	Active Comparator		Drug: Vildagliptin 50 MG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Metformin Hydrochloride tablet	Drug	Metformin Hydrochloride 850 mg oral tablet	Metformin

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
ahmed hussein, phD	Contact	01001749605		ahmedhussein.med@o6u.edu.eg
ahmed hussein	Contact			ahmedhussein.med@o6u.edu.eg

Overall Officials

Name	Affiliation	Role
ahmed hussein, PhD	october 6 university hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
October 6 university hospital	Recruiting	Giza		12585	Egypt

Intervention Browse Module

MeSH Terms

ID	Term
D008687	Metformin
D000077597	Vildagliptin

Ancestor Terms

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals
D009570

Browse Leaves

Not provided

Browse Branches

Not provided