Evaluating biomarkers for diagnosing PCOS in young women
Polycystic Ovarian Syndrome (PCOS) in Human Adolescent and Young Adult Females - Biomarker Evaluation Study (PHOEBE)
This study is testing new blood markers to see if they can help doctors better diagnose Polycystic Ovarian Syndrome (PCOS) in young women aged 15-25.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 380 (estimated) |
| Ages | 15 Years to 25 Years |
| Sex | Female |
| Sponsor | University Hospital Erlangen Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Erlangen) |
| Trial ID | NCT06642831 on ClinicalTrials.gov |
What this trial studies
This study aims to validate biomarkers that can help diagnose Polycystic Ovarian Syndrome (PCOS) in adolescent and young adult women aged 15-25. Participants will attend a single visit for clinical data collection and a blood draw to measure relevant serum parameters. Those diagnosed with PCOS will have two follow-up visits to monitor treatment and collect additional data. The study focuses on improving diagnostic accuracy for PCOS in this age group.
Who should consider this trial
Good fit: Ideal candidates are female adolescents and young adults aged 15-25 who may be experiencing symptoms of PCOS.
Not a fit: Patients who have recently started menstruating, are using hormonal contraceptives, or have major ovarian abnormalities will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and timely diagnoses of PCOS in young women.
How similar studies have performed: Other studies have shown promise in using biomarkers for diagnosing PCOS, but this specific approach is focused on a younger demographic.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Erlangen
- Department of Obstetrics and Gynecology, University Erlangen Hospital, Friedrich Alexander University of Erlangen-Nuremberg, Erlangen, Germany — Erlangen, Germany (Recruiting)
Study contacts
- Principal investigator: Ralf Dittrich, Prof. — University Hospital Erlangen
- Study coordinator: Laura Lotz, Dr. med.
- Email: laura.lotz@uk-erlangen.de
- Phone: +49 9131 85 44023
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.