Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Bone Status and Insulin Resistance in Hirsutism
This study has been completed.
Sponsored by: Odense University Hospital
Information provided by: Odense University Hospital
ClinicalTrials.gov Identifier: NCT00143052
  Purpose

The purpose of this study is to investigate how the bones of hirsute women are different from bones of healthy women. The change in hormone content in the blood will also be investigated. The study can be used to evaluate whether it will be relevant to bone scan all newly referred hirsute women.

Hirsute women are often over-weight and often have an increased amount of the male sex hormone in their blood. Their blood tests often show changes reminding of the ones seen in diabetic patients.

All hirsute women referred to the department will undergo an investigation revealing the reason for the increased hair growth. The investigation includes clinical investigation (height, weight and degree of hair growth), blood tests (for hormone status and bone status analysis) and bone scanning of the abdomen (body composition).

The trial includes a group of 50 strongly hairy women and a control group of 50 healthy women with normal hair growth. They are matched by body weight, since weight has great importance for the bone mineral content and thereby for osteoporosis in the long run.


Condition
Hirsutism

Drug Information available for: Insulin
U.S. FDA Resources
Study Type: Observational
Study Design: Case Control, Prospective
Official Title: Body Composition, Insulin Concentration, Androgens and Bone Status in Women Referred With Hirsutism

Further study details as provided by Odense University Hospital:

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

Enrollment: 50
Study Start Date: January 2002
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years to 46 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Study Population

hirsute patients vs. controls

Criteria

Inclusion Criteria:

Hirsute subjects:

  • Belonging to group 1 or 2.
  • Age: 20-46
  • Hirsute score: >7
  • Written informed consent

Control group:

  • Age: 20-46
  • Hirsute score: 0 (without razing)
  • Regular menses
  • Written informed consent

Exclusion Criteria:

  • Previous cosmetic treatment for hirsutism.
  • Use of contraceptive pill (within the past 6 months)
  • Systemic steroid treatment > 6 weeks (ever)
  • Age above 46 years/post menopause (increased FSH)
  • Recognized diabetes mellitus or other endocrine disease
  • Eating disorder
  • Serious, treatment demanding disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00143052

Locations
Denmark, Funen
Diabetes Research Center
Odense, Funen, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Investigators
Principal Investigator: Dorte Glintborg, MD Odense University Hospital
  More Information

Responsible Party: Odense University Hospital
Study ID Numbers: 003
Study First Received: September 1, 2005
Last Updated: June 23, 2008
ClinicalTrials.gov Identifier: NCT00143052  
Health Authority: Denmark: National Board of Health

Keywords provided by Odense University Hospital:
Hirsutism
Bone status
Androgens
insulin

Study placed in the following topic categories:
Signs and Symptoms
Hirsutism
Skin Diseases
Insulin Resistance
Insulin

Additional relevant MeSH terms:
Hair Diseases
Virilism

ClinicalTrials.gov processed this record on January 16, 2009