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NCT01338519 Clinical Trial

Database Study on Patients With PCOS

PCOS Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01338519
Other study ID # PCOSDatabaseOdense
Secondary ID
Status Recruiting
Phase N/A
First received April 18, 2011
Last updated April 18, 2011
Start date January 1997
Est. completion date January 2020

Study information
Verified date January 1997
Source Odense University Hospital
Contact Dorte Glintborg, MD, PhD
Email dorte.glintborg@ouh.regionsyddanmark.dk
Is FDA regulated No
Health authority Denmark: Central Videnskabsetik komite
Study type Observational

Clinical Trial Summary

All newly referred patients with PCOS and hirsutism are listed in a database.

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

Recruitment information / eligibility
Status Recruiting
Enrollment 2000
Est. completion date January 2020
Est. primary completion date January 2020
Accepts healthy volunteers No
Gender Female
Age group 15 Years to 50 Years
Eligibility Inclusion Criteria:

- premenopausal

- hirsutism or PCOS

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark Odense University Hospital Odense

Sponsors (1)
Lead Sponsor Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

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