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Bone Status and Insulin Resistance in Hirsutism

This study has been completed.
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00143052
First received: September 1, 2005
Last updated: June 23, 2008
Last verified: June 2008
History of Changes
  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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Body Composition, Insulin Concentration, Androgens and Bone Status in Women Referred With Hirsutism

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Odense University Hospital:

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

No publications provided

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

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

Additional relevant MeSH terms:
Hirsutism
Hypertrichosis
Insulin Resistance
Hair Diseases
Skin Diseases
Virilism
Signs and Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
 Metabolic Diseases
Androgens
Insulin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Hypoglycemic Agents

ClinicalTrials.gov processed this record on May 16, 2013