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Bone Status and Insulin Resistance in Hirsutism

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ClinicalTrials.gov Identifier: NCT00143052
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : June 24, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:

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 or disease
Hirsutism

Study Design

Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Body Composition, Insulin Concentration, Androgens and Bone Status in Women Referred With Hirsutism
Study Start Date : January 2002
Primary Completion Date : January 2007
Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 46 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Odense University Hospital
ClinicalTrials.gov Identifier: NCT00143052     History of Changes
Other Study ID Numbers: 003
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: June 24, 2008
Last Verified: June 2008

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

Additional relevant MeSH terms:
Hirsutism
Hair Diseases
Skin Diseases
Virilism
Signs and Symptoms
Insulin
Androgens
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists