Pioglitazone Treatment in Polycystic Ovary Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00145340
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : September 26, 2008
Information provided by:
Odense University Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: pioglitazone Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : September 2002
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: pioglitazone
    30 Mg/day

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00145340

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Odense University Hospital Identifier: NCT00145340     History of Changes
Other Study ID Numbers: 032
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: September 26, 2008
Last Verified: September 2008

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

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