Polycystic Ovarian Syndrome (PCOS) Biomarker Evaluation Study (PHOEBE)

University Hospital Erlangen

Status

Enrolling

Conditions

Polycystic Ovarian Syndrome (PCOS)

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT06642831

22-114-B

Details and patient eligibility

About

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

Full 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.

Enrollment

380 estimated patients

Sex

Female

Ages

15 to 25 years old

Volunteers

Accepts Healthy Volunteers

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)