Characterization of a Prospective Cohort of Women With PCOS

Recruiting

• Conditions: Polycystic Ovary Syndrome

• Registration Number: NCT02010814
• Lead Sponsor: Odense University Hospital

Brief Summary

Polycystic ovary syndrome (PCOS) is a common endocrine disorder in premenopausal women. PCOS is characterized by increase levels of testosterone, unwanted hair growth, adiposity, irregular menstrual cycle, and infertility. PCOS is associated with diabetes mellitus and cardiovascular diseases. Women with PCOS are reported to have increased levels of stress hormones, which may be associated with decreased quality of life. Increased testosterone levels in women may decrease the risk of osteoporosis. The aim of the present study is to measure levels of stress hormones in urine and describe quality of life using questionnaires. In addition we aim to characterize body composition and bone architecture using DXA and ExtremeCT.

As part of the project, a Biobank with fasting blood samples from participants is established.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-01
• Study First Submitted: 2013-11-21
• Study First Submitted QC: 2013-12-09
• Study First Posted: 2013-12-13
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-24
• Last Update Posted: 2023-04-25
• Primary Completion: 2027-01-01
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

• PCOS

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Exclusion Criteria

• pregnancy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
bone mass density (BMD)	baseline	BMD measured by DXA scans and ExtremeCT scans.

Secondary Outcome Measures

Name	Time	Method
Stress hormones	Baseline	Measurement of cortisol and steroid metabolites in 24 hour urine samples

Trial Locations

Locations (1)

Department of Endocrinology, Odense University Hospital; 🇩🇰 Odense, Denmark