HirsutismNCT00143052
Bone Status and Insulin Resistance in Hirsutism
An observational study of Hirsutism, run by Odense University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 46 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hirsutism
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2002to Jan 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 46 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: hirsute patients vs. controls
Who may be able to join
- Hirsute subjects:
- Belonging to group 1 or 2.
- Age: 20-46
- Hirsute score: >7
- Written informed consent
- Control group:
Show all 10Show fewer
- Age: 20-46
- Hirsute score: 0 (without razing)
- Regular menses
- Written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Body Composition, Insulin Concentration, Androgens and Bone Status in Women Referred With Hirsutism
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.
Read more
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.
- Conditions
- Hirsutism
- Keywords
- Hirsutism, Bone status, Androgens, insulin
- Medical subject headings
- Hirsutism, Insulin Resistance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startJan 2002
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HirsutismStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Dorte Glintborg, MD, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00143052
- Sponsor's protocol ID
- 003
- Status last verified
- Jun 2008
- First submitted
- 1 Sep 2005
- Last updated
- 24 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Composition, Insulin Concentration, Androgens and Bone Status in Women Referred With Hirsutism
- ClinicalTrials.gov ID
- NCT00143052
- Acronym / sponsor ID
- 003
- Conditions
- Hirsutism
- Keywords
- Hirsutism, Bone status, Androgens, insulin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Jan 2002
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 2 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 46 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- hirsute patients vs. controls
Key inclusion criteria (10 listed)
- Belonging to group 1 or 2.
- Age: 20-46
- Hirsute score: >7
- Written informed consent
- Age: 20-46
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dorte Glintborg, MD principal investigator
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hirsutism, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2008.