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Database Study on Patients With PCOS

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ClinicalTrials.gov Identifier: NCT01338519
Recruitment Status : Recruiting
First Posted : April 19, 2011
Last Update Posted : April 19, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
All newly referred patients with PCOS and hirsutism are listed in a database.

Condition or disease
Hirsutism PCOS

Detailed Description:

All premenopausal women referred to the outpatient clinic at the Department of Endocrinology from 1997 and onward with the referral diagnoses hirsutism and/or PCOS are included in a clinical database. The patients should fulfill the Rotterdam criteria for PCOS or have clinical/biochemical hyperandrogenemia.

Routine evaluation include medical history, clinical examination, transvaginal ultrasound (US), and fasting blood samples. Cycle history is recorded in all patients using a standard scheme prepared for hirsute patients. Blood tests include androgens, LH, FSH, prolactin, and lipid profile.

OGTT and ACTH are performed in high risk patients


Study Design

Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : January 1997
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020
Groups and Cohorts

Group/Cohort
PCOS and hirsutism


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Premenopausal women referred with hirsutism or PCOS to Odense University hospital
Criteria

Inclusion Criteria:

  • premenopausal
  • hirsutism or PCOS
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): NCT01338519


Contacts
Contact: Dorte Glintborg, MD, PhD dorte.glintborg@ouh.regionsyddanmark.dk

Locations
Denmark
Odense University Hospital Recruiting
Odense, Denmark, DK-5000
Contact: Dorte Glintborg, MD, PhD       dorte.glintborg@ouh.regionsyddanmark.dk   
Principal Investigator: Dorte Glintborg, MD, PhD         
Sponsors and Collaborators
Odense University Hospital
Investigators
Principal Investigator: Marianne Andersen, MD, PhD Odense Univeristy Hospital
More Information

ClinicalTrials.gov Identifier: NCT01338519     History of Changes
Other Study ID Numbers: PCOSDatabaseOdense
First Posted: April 19, 2011    Key Record Dates
Last Update Posted: April 19, 2011
Last Verified: January 1997

Additional relevant MeSH terms:
Hirsutism
Hair Diseases
Skin Diseases
Virilism
Signs and Symptoms