NCT06015594

Brief Summary

This study aimed to understand whether metformin therapy can improve insulin resistance in adolescent PCOS patients, both during treatment and after discontinuation, and to evaluate its action on the hormonal and metabolic pathways.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

August 29, 2023

Completed
Last Updated

August 29, 2023

Status Verified

August 1, 2023

Enrollment Period

4.6 years

First QC Date

August 3, 2023

Last Update Submit

August 22, 2023

Conditions

Polycystic Ovary Syndrome

Keywords

insulin resistancemetforminadolescents

Outcome Measures

Primary Outcomes (2)

  • Insulin resistance change in eighty hyperinsulinemic patients after metformin therapy and its discontinuation

    To verify metformin treatment's immediate and long-term efficacy in hyperinsulinemic adolescent patients with PCOS and the evolution of metabolic status after treatment discontinuation.

    about 3 years

  • Androgen levels change in eighty hyperinsulinemic patients after metformin therapy and its discontinuation

    To compare changes in androgen plasmatic levels such as total testosterone (TT) and delta-4-androstenedione (A) between the hyperinsulinemic adolescent patients with PCOS and the control group who have not received the metformin treatment by immediate and secondary assessment at the end of treatment of androgen plasmatic levels.

    about 3 years

Study Arms (2)

Metformin group

EXPERIMENTAL

Treated with metformin

Drug: Metformin

Control group

NO INTERVENTION

not treated

Interventions

MetforminDRUG

Patients treated with metformin

Metformin group

Eligibility Criteria

Age10 Years - 19 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may not qualify if:

  • Other type of hyperandrogenism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Polycystic Ovary SyndromeInsulin Resistance

Interventions

Metformin

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator (Medical doctor)

Study Record Dates

First Submitted

August 3, 2023

First Posted

August 29, 2023

Study Start

January 1, 2015

Primary Completion

August 1, 2019

Study Completion

May 1, 2022

Last Updated

August 29, 2023

Record last verified: 2023-08