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Recruiting NCT02010814

Characterization of a Prospective Cohort of Women With PCOS

Observational Polycystic Ovary Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Polycystic Ovary Syndrome. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • bone mass density (BMD) [Time frame: baseline]
Secondary outcome measures (1)
  • Stress hormones [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • PCOS

Exclusion criteria

  • pregnancy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

Denmark · 1 center
  • Department of Endocrinology, Odense University Hospital — Odense

Identifiers

NCT: NCT02010814 · BIO · PCOS Biobank

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗