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Pioglitazone Treatment in Polycystic Ovary Syndrome

This study has been completed.
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00145340
First received: September 2, 2005
Last updated: September 25, 2008
Last verified: September 2008
  Purpose

In this study, the investigators wish to investigate how pioglitazone treatment effects hirsute women. Hirsute women are often overweight and have an increased amount of male sex hormone in their blood. Their blood tests show frequent changes corresponding to the changes seen in diabetic patients.

Pioglitazone is a drug used for increasing the insulin sensitivity in diabetic patients. Previous studies showed that this drug is able to decrease the level of insulin in blood in hirsute women. Moreover, the level of male sex hormones is reduced during this treatment. The drug has only been marketed for few years, and no investigations have been carried out as to the reaction of other hormones, e.g. growth hormone and stress hormone, using this treatment.

This clinical trial includes 30 strongly hirsute women. The patients are randomized to either placebo or an active drug. The treatment period is 16 weeks. The patients included must be healthy and take no medicine possibly changing the results of the study. The patients must take no contraceptive pills or receive any other hormone treatment.

In connection with the investigation, the following will be carried out on all patients: glucose tolerance test, clinical examination, blood tests, measurement of stress hormones and sex hormones, hyperinsulinaemic euglycaemic clamp test, muscle biopsies and bone scan.

This examination programme will be carried out before start of pioglitazone or placebo treatment and again after 16 weeks of treatment. The examinations require 2½ days of hospitalization.

The purpose of the study is to gain more knowledge of the reasons for hirsute women to grow more hair than normal women. The study will show whether pioglitazone treatment can reduce the amount of male sex hormone in blood and how the level of stress hormone and growth hormone is changed when reducing the amount of insulin in blood.


Condition Intervention Phase
Polycystic Ovary Syndrome
Drug: pioglitazone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Effect of PPARgamma Stimulation on Glucose Metabolism, Insulin Resistance, Growth Hormone and Cortisol on Women Suffering From Polycystic Ovary Syndrome

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Glucose infusion rate (M value) below euglycaemic hyperinsulinaemic clamp (comparing baseline with 4 months)

Estimated Enrollment: 30
Study Start Date: September 2002
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: pioglitazone
    30 Mg/day
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Irregular menses, i.e. cyclus length of >36 days
  • Premenopausal
  • Increased fasting insulin > 50 pmol/l
  • Increased free testosterone > 0.035 nmol/l

Exclusion Criteria:

  • Age: <18 years
  • Contraceptive pill within the past 3 months
  • Postmenopausal (increased FSH)
  • Known diabetes mellitus, endocrine disease or other disease requiring treatment
  • Drug use
  • Pregnancy
  • Planned pregnancy during the treatment period
  • Increased liver parameters
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00145340

Locations
Denmark
Department of Endocrinology, Odense University Hospital
Odense, Funen, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Investigators
Principal Investigator: Dorte Glintborg, MD Odense University Hospital
  More Information

No publications provided by Odense University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Odense University Hospital
ClinicalTrials.gov Identifier: NCT00145340     History of Changes
Other Study ID Numbers: 032
Study First Received: September 2, 2005
Last Updated: September 25, 2008
Health Authority: Denmark: National Board of Health

Keywords provided by Odense University Hospital:
polycystic ovary syndrome (PCOS)
PPARgamma
growth hormone
insulin resistance
pioglitazone
glucose metabolism
microarray

Additional relevant MeSH terms:
Insulin Resistance
Polycystic Ovary Syndrome
Syndrome
Adnexal Diseases
Cysts
Disease
Endocrine System Diseases
Genital Diseases, Female
Glucose Metabolism Disorders
Gonadal Disorders
Hyperinsulinism
Metabolic Diseases
Neoplasms
Ovarian Cysts
Ovarian Diseases
Pathologic Processes
Pioglitazone
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014