Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00145340
Status:
COMPLETED
Last Update Posted:
2008-09-26
First Post:
2005-09-02
Brief Title:
Pioglitazone Treatment in Polycystic Ovary Syndrome
Sponsor:
Odense University Hospital
Organization:
Odense University Hospital
Study Overview
Official Title:
The Effect of PPARgamma Stimulation on Glucose Metabolism Insulin Resistance Growth Hormone and Cortisol on Women Suffering From Polycystic Ovary Syndrome
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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
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 eg 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None