Bone Status and Insulin Resistance in Hirsutism - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 1, 2005

Last Updated Date

June 23, 2008

Start Date ^†

January 2002

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00143052 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Bone Status and Insulin Resistance in Hirsutism

Official Title ^†

Body Composition, Insulin Concentration, Androgens and Bone Status in Women Referred With Hirsutism

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.

Detailed Description

Study Phase

Study Type ^†

Observational

Study Design ^†

Case Control, Prospective

Condition ^†

Hirsutism

Intervention ^†

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

January 2007

Primary Completion Date

January 2007 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Female

Ages

20 Years to 46 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Denmark

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00143052

Responsible Party

Odense University Hospital

Secondary IDs ^††

Study Sponsor ^†

Odense University Hospital

Collaborators ^††

Investigators ^†

Principal Investigator:

Dorte Glintborg, MD

Odense University Hospital

Information Provided By

Odense University Hospital

Verification Date

June 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.