Database Study on Patients With PCOS

This study is currently recruiting participants.
Verified January 1997 by Odense University Hospital
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01338519
First received: April 18, 2011
Last updated: NA
Last verified: January 1997
History: No changes posted
  Purpose

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


Condition
Hirsutism
PCOS

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by Odense University Hospital:

Estimated Enrollment: 2000
Study Start Date: January 1997
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
PCOS and hirsutism

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

  Eligibility

Ages Eligible for Study:   15 Years to 50 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT01338519     History of Changes
Other Study ID Numbers: PCOSDatabaseOdense
Study First Received: April 18, 2011
Last Updated: April 18, 2011
Health Authority: Denmark: Central Videnskabsetik komite

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

ClinicalTrials.gov processed this record on April 21, 2014