Database Study on Patients With PCOS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01338519
Recruitment Status : Recruiting
First Posted : April 19, 2011
Last Update Posted : April 19, 2011
Information provided by:
Odense University Hospital

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 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

PCOS and hirsutism

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

Inclusion Criteria:

  • premenopausal
  • hirsutism or PCOS

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 identifier (NCT number): NCT01338519

Contact: Dorte Glintborg, MD, PhD

Odense University Hospital Recruiting
Odense, Denmark, DK-5000
Contact: Dorte Glintborg, MD, PhD   
Principal Investigator: Dorte Glintborg, MD, PhD         
Sponsors and Collaborators
Odense University Hospital
Principal Investigator: Marianne Andersen, MD, PhD Odense Univeristy Hospital 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:
Hair Diseases
Skin Diseases
Signs and Symptoms