Actively Recruiting

Age: 18Years - 45Years
FEMALE
Healthy Volunteers
ID02010814

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

Led by Odense University Hospital · Updated on 2023-04-25

500

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Polycystic ovary syndrome (PCOS) is a common hormonal disorder affecting women before menopause, often marked by high testosterone levels, excess hair growth, body fat, irregular periods, and difficulties with fertility. PCOS is linked to diabetes and heart disease, and women with PCOS may experience higher stress hormone levels, which can impact their quality of life. This study aims to measure stress hormone levels in urine and assess quality of life through questionnaires, while also examining body composition and bone structure using specialized scans. Participants who meet at least two of the three Rotterdam criteria for PCOS—irregular menstrual cycles, signs of high androgen levels, or polycystic ovaries—will be included. The study collects fasting blood samples for a biobank, and uses DXA and ExtremeCT scans to evaluate bone density and architecture. This observational study focuses on characterizing women with PCOS without administering any treatments. During the study, participants will complete questionnaires about their quality of life and provide urine and blood samples for hormone analysis. They will undergo body scans to assess bone density and structure at the start of the study. Researchers will monitor bone mass density as the primary outcome and stress hormone levels as a secondary outcome. The study follows participants over time to better understand PCOS and its impact on health and well-being.

CONDITIONS

Brief Title

Characterization of a Prospective Cohort of Women With PCOS

Who Can Participate

Age: 18Years - 45Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female aged 18 to 45 years
  • Diagnosed with polycystic ovary syndrome (PCOS)
  • Fulfills at least two of the three Rotterdam criteria for PCOS: irregular menstrual cycle, clinical or biochemical signs of high androgen levels, or polycystic ovaries
Not Eligible

You will not qualify if you...

  • Currently pregnant

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Baseline assessment

Participants undergo assessments to characterize metabolic and endocrinological features of PCOS.

1 visit (in-person)

Long-term Monitoring

Duration - Up to several years

Participants are observed over time to monitor bone mass density and stress hormone levels.

Visit schedule not specified

Trial Site Locations

Total: 1 location

1

Department of Endocrinology, Odense University Hospital

Odense, Denmark, 5000

Actively Recruiting

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Research Team

M

Marianne Andersen, DMSci

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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