Pioglitazone Treatment in Polycystic Ovary Syndrome
Status:
Completed
Trial end date:
2007-01-01
Target enrollment:
Participant gender:
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.