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NCT02010814 Clinical Trial

Characterization of a Prospective Cohort of Women With PCOS

Polycystic Ovary Syndrome Clinical Trial

Official title:
Metabolic and Endocrinological Characterization of a Prospective Cohort of Women With PCOS

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02010814
Other study ID # BIO
Secondary ID PCOS Biobank
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2012
Est. completion date January 1, 2028

Study information
Verified date April 2023
Source Odense University Hospital
Contact Marianne Andersen, DMSci
Phone 0045 65412502
Email marianne.andersen@rsyd.dk
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date January 1, 2028
Est. primary completion date January 1, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - PCOS Exclusion Criteria: - pregnancy

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark Department of Endocrinology, Odense University Hospital Odense

Sponsors (1)
Lead Sponsor Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary bone mass density (BMD) BMD measured by DXA scans and ExtremeCT scans. baseline
Secondary Stress hormones Measurement of cortisol and steroid metabolites in 24 hour urine samples Baseline
See also
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Completed NCT05246306 - Aerobic Capacity and Physical Fitness Level of Adolescents With PCOS
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Completed NCT02924025 - Motivational Interviewing as an Intervention for PCOS N/A
Not yet recruiting NCT00883259 - Metformin and Gestational Diabetes in High-risk Patients: a RCTs Phase 4
Withdrawn NCT01638988 - Clomifene Citrate Versus Metformin in First-line Treatment of Infertility in Patients With Polycystic Ovary Syndrome and a Resistance to Insulin Phase 3
Completed NCT02098668 - Mathematical Model for the Human Menstrual Cycle, Endocrinological Diseases and Fertility Treatment-PAEON N/A
Completed NCT01462864 - Development of a Structured Education Programme for Women With Polycystic Ovary Syndrome N/A
Recruiting NCT01431352 - Letrozole Versus Chinese Herbal Medicine on Polycystic Ovary Syndrome (PCOS) N/A
Completed NCT00989781 - Mechanisms of Increased Androgen Production Among Women With Polycystic Ovary Syndrome N/A