NCT00319293

Brief Summary

Insulin resistance is an important feature of the polycystic ovary syndrome,and patiens are successfully treated with the insulin sensitizing agent metformin. The insulin resistance of lean patients with the syndrome is debated. In this study, we will study the change in insulin resistance, metabolic and hormonal factors after 3 months of metformin treatment in lean PCOS women.

Trial Health

50
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

April 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 27, 2006

Completed
Last Updated

October 11, 2006

Status Verified

October 1, 2006

First QC Date

April 26, 2006

Last Update Submit

October 10, 2006

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (3)

  • Insulin resistance

  • Hormonal factors

  • Metabolic factors

Interventions

MetforminDRUG

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • PCOS (Rotterdam criteria)
  • BMI \< 27
  • No medication for 3 months

You may not qualify if:

  • Pregnancy
  • Lactation
  • Other endocrinologic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Metformin

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Birgitta Trolle, MD

    Skejby University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 26, 2006

First Posted

April 27, 2006

Last Updated

October 11, 2006

Record last verified: 2006-10