Characterization of a Prospective Cohort of Women With PCOS

NCT02010814 | Recruiting

• 2 other identifiers: BIOPCOS Biobank
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome

Keywords

PCOS; Inflammation; Body Composition

Outcome Measures

Primary Outcomes (1)

• bone mass density (BMD)

  BMD measured by DXA scans and ExtremeCT scans.

  baseline

Secondary Outcomes (1)

• Stress hormones

  Baseline

Study Arms (1)

PCOS

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women with PCOS, diagnosed by the Rotterdam criteria which include at least two of the following: * irregular mestrual cycle * polycystic ovaries * biochemical/clinical hyperandrogenemia

You may qualify if:

• PCOS

You may not qualify if:

• pregnancy

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Department of Endocrinology, Odense University Hospital

Odense, 5000, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine samples

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Inflammation

Condition Hierarchy (Ancestors)

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

Study Officials

• Dorte Glintborg, MD PhD

  Department of Endocrinology, Odense University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marianne Andersen, DMSci

CONTACT

0045 65412502; marianne.andersen@rsyd.dk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DMSci

Study Record Dates

• First Submitted: November 21, 2013
• First Posted: December 13, 2013
• Study Start: January 1, 2012
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 25, 2023

Record last verified: 2023-04

Locations

DK (1)