NCT00437333

Brief Summary

Metformin is an insulin sensitizing drug routinely used for the treatment of anovulatory patients with polycystic ovary syndrome (PCOS). To date, the metabolic effects of the long-term metformin administration are know but no data are available on the effects after its suspension. The purpose of this study is to evaluate the effects of metformin suspension on insulin sensitivity in PCOS patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2003

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 21, 2007

Completed
Last Updated

February 21, 2007

Status Verified

February 1, 2007

First QC Date

February 20, 2007

Last Update Submit

February 20, 2007

Conditions

Polycystic Ovary Syndrome

Keywords

Insulin sensitivityInsulin-sensitizing drugMetforminPCOSTreatment

Outcome Measures

Primary Outcomes (1)

  • Insulin sensitivity by euglycemic hyperinsulinemic clamp

Secondary Outcomes (1)

  • Clinical, hormonal, and metabolic assessments

Interventions

Metformin cloridrateDRUG

Eligibility Criteria

Age20 Years - 30 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Polycystic ovary syndrome (using NIH criteria).

You may not qualify if:

  • Age \<20 or \>30 years;
  • BMI higher than 25 and lower than 18;
  • Neoplastic, metabolic, hepatic, and cardiovascular disorders or other concurrent medical illnesses;
  • Hypothyroidism, hyperprolactinemia, Cushing's syndrome, and non-classical congenital adrenal hyperplasia;
  • Current or previous use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other hormonal drugs;
  • Intention to start a diet or a specific program of physical activity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

"Pugliese" Hospital

Catanzaro, 88100, Italy

Location

MeSH Terms

Conditions

Polycystic Ovary SyndromeInsulin Resistance

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

Study Officials

  • Stefano Palomba, MD

    Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 20, 2007

First Posted

February 21, 2007

Study Start

December 1, 2003

Study Completion

April 1, 2006

Last Updated

February 21, 2007

Record last verified: 2007-02

Locations

IT(1)