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NCT Number: NCT02010814

Characterization of a Prospective Cohort of Women With PCOS

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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Inflammation Neoplasms Ovarian Cysts Ovarian Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Department of Endocrinology, Odense University Hospital

Odense, 5000, Denmark

Location status: Recruiting

Location contact

Dorte Glintborg, MD PhD

CONTACT

[email protected]

0045 65412502

Marianne Andersen, DMSci

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • PCOS

Exclusion criteria

  • pregnancy

Treatment and study plan

Primary outcomes

  1. bone mass density (BMD)

    Time frame: baseline

    BMD measured by DXA scans and ExtremeCT scans.

Secondary outcomes

  1. Stress hormones

    Time frame: Baseline

    Measurement of cortisol and steroid metabolites in 24 hour urine samples

Study contacts

Contact information is provided by the study sponsor or research team.

Marianne Andersen, DMSci

CONTACT

[email protected]

0045 65412502

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Official study title

Metabolic and Endocrinological Characterization of a Prospective Cohort of Women With PCOS

Important dates

Study start
2012
Primary completion
2027
Study completion
2028
First posted
Dec 13, 2013
Registry last updated
Apr 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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