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Prospective Study of Patients With Hirsutism

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2007 by Odense University Hospital.
Recruitment status was:  Active, not recruiting
Information provided by:
Odense University Hospital Identifier:
First received: September 2, 2005
Last updated: March 23, 2007
Last verified: March 2007

Hirsutism is the presence of terminal hairs in a male-like pattern in females, due to elevated male hormone levels. Females with hirsutism are often overweight and have metabolism disturbances as insulin resistance and impaired glucose tolerance.

The previous studies showed that patients with hirsutism (especially them with polycystic ovarian syndrome (PCOS)) have an increased risk to develop type 2 diabetes mellitus on the background of insulin resistance / hyperinsulinemia: 30-35 % of females with PCOS had impaired glucose tolerance and 5-10 % of them diabetes. Hyperinsulinemia increases the risk to develop dyslipidemia and cardiovascular diseases.

A previous study in our department who included 340 females with hirsutism (210 with idiopathic hirsutism and 134 with PCOS) showed that 6.6% of them had diabetes and 55% insulin resistance.

There were only few long-term follow up studies of patients with hirsutism concerning their risk to develop diabetes. As far as we now, such studies on patients with idiopathic hirsutism are not available until now.

Hirsutism is been treated with low dose oral contraceptives, which are suppressing androgen production. This treatment can also influence the risk to develop diabetes and atheromatosis. The previous studies showed that the low dose oral contraceptives had modest influence on the lipid profiles and carbohydrate metabolism in patients with hirsutism, but increased the risk to develop coronary disease.


  • To study and quantify, in patients with hirsutime, the risk to develop type 2 diabetes on the background of insulin resistance / decreased glucose tolerance and atheromatosis on the background of insulin resistance / hypercholesterolemia.
  • To clarify the effect of P-pills on patients hair growth and metabolism.

Condition Phase
Hirsutism Type 2 Diabetes Polycystic Ovary Syndrome Phase 2 Phase 3

Study Type: Observational
Study Design: Observational Model: Case Control
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Prospective Study of Patients Med Hirsutism as Primary Work Diagnose

Further study details as provided by Odense University Hospital:

Estimated Enrollment: 340
Study Start Date: October 2003
Estimated Study Completion Date: March 2005
  Show Detailed Description


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

Inclusion Criteria:

  • The patients which had been included in the previous study between 1997 – 2000, oral glucose tolerance test included.

Exclusion Criteria:

  • Pregnancy
  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 identifier: NCT00145288

Department of Endocrinology, Odense University Hospital
Odense, Funen, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Principal Investigator: Magdalena Andries, MD Odense University Hospital
  More Information Identifier: NCT00145288     History of Changes
Other Study ID Numbers: 010
Study First Received: September 2, 2005
Last Updated: March 23, 2007

Keywords provided by Odense University Hospital:
type 2 diabetes
polycystic ovary syndrome

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Polycystic Ovary Syndrome
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Hair Diseases
Skin Diseases
Signs and Symptoms processed this record on August 21, 2017