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Polycystic Ovarian Syndrome (PCOS) Biomarker Evaluation Study

Polycystic Ovarian Syndrome (PCOS) Biomarker Evaluation Study

Recruiting
15-25 years
Female
Phase N/A

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Overview

The purpose of the study is to validate recently identified biomarkers for the identification of PCOS in adolecent and young adult women.

Description

The purpose of the study is to validate potential biomarkers for the aid in the diagnosis of PCOS in adolescent and young adult women in the age range of 15-25 years. Female subjects included in this study will have one visit where clinical data for assessing PCOS will be collected and a blood draw will be performed to collect serum for measurement of parameters relevant to PCOS will be performed. Study subjects that receive a PCOS diagnosis will have two follow up visits for follow up on treatment where additional serum and clinical data will be collected. The first visit will be 3 months after receiving the diagnosis and the second visit 6-12 months after the initial visit.

Eligibility

Inclusion Criteria:

  • Female subjects age 15-25 years
  • Signed written informed consent

Exclusion Criteria:

  • Less than 1 years from onset of menarche
  • Use of hormonal contraceptives
  • Documented ongoing pregnancy
  • Major ovarian abnormalities, including subject with only one ovary, cysts and solid masses > 2 cm as detected by transvaginal ultrasound
  • Malignancy ( documented malignancy, documentation of current radiation therapy or chemotherapy in medical record)

Study details
    Polycystic Ovarian Syndrome (PCOS)

NCT06642831

University Hospital Erlangen

16 October 2025

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