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Characterization of a Prospective Cohort of Women With PCOS

Sponsor
Odense University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT02010814
Collaborator
(none)
500
Enrollment
1
Location
168
Anticipated Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Metabolic and Endocrinological Characterization of a Prospective Cohort of Women With PCOS
    Actual Study Start Date :
    Jan 1, 2012
    Anticipated Primary Completion Date :
    Jan 1, 2025
    Anticipated Study Completion Date :
    Jan 1, 2026

    Arms and Interventions

    Arm Intervention/Treatment
    PCOS

    Women fulfilling at least two of the three Rotterdam criteria for PCOS, including Irregular menstrual cycle Clinical/biochemical hyperandrogenemia Polycystic ovaries

    Outcome Measures

    Primary Outcome Measures

    1. bone mass density (BMD) [baseline]

      BMD measured by DXA scans and ExtremeCT scans.

    Secondary Outcome Measures

    1. Stress hormones [Baseline]

      Measurement of cortisol and steroid metabolites in 24 hour urine samples

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • PCOS
    Exclusion Criteria:
    • pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Endocrinology, Odense University Hospital Odense Denmark 5000

    Sponsors and Collaborators

    • Odense University Hospital

    Investigators

    • Principal Investigator: Dorte Glintborg, MD PhD, Department of Endocrinology, Odense University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Marianne Andersen, DMSci, Odense University Hospital
    ClinicalTrials.gov Identifier:
    NCT02010814
    Other Study ID Numbers:
    • BIO
    • PCOS Biobank
    First Posted:
    Dec 13, 2013
    Last Update Posted:
    Dec 27, 2021
    Last Verified:
    Dec 1, 2021
    Keywords provided by Marianne Andersen, DMSci, Odense University Hospital
    PCOS
    Inflammation
    Body Composition
    Additional relevant MeSH terms:
    Polycystic Ovary Syndrome

    Study Results

    No Results Posted as of Dec 27, 2021