Database Study on Patients With PCOS

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 01, 2014