NCT00143052

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

June 24, 2008

Status Verified

June 1, 2008

Enrollment Period

5 years

First QC Date

September 1, 2005

Last Update Submit

June 23, 2008

Conditions

Keywords

HirsutismBone statusAndrogensinsulin

Eligibility Criteria

Age20 Years - 46 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Study Population

hirsute patients vs. controls

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabetes Research Center

Odense, Funen, 5000, Denmark

Location

MeSH Terms

Conditions

HirsutismInsulin Resistance

Condition Hierarchy (Ancestors)

Hair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesVirilismSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Dorte Glintborg, MD

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 2, 2005

Study Start

January 1, 2002

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

June 24, 2008

Record last verified: 2008-06

Locations