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NCT Number: NCT06642831

Polycystic Ovarian Syndrome (PCOS) Biomarker Evaluation Study

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

Recruiting

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Key information

Age range

15 year–25 year

Sex eligibility

Female

Study type

Observational

Primary location

Department of Obstetrics and Gynecology, University Erlangen Hospital, Friedrich Alexander University of Erlangen-Nuremberg, Erlangen, Germany

Erlangen, 91054, Germany

Location status: Recruiting

Location contact

Laura Lotz, Dr

CONTACT

[email protected]

+49 9131 85 44023

Ralf Dittrich, Prof

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. The validation of new potential biomarkers for aid in the diagnoisis of PCOS in adolescent and young adult women

    Time frame: Baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Laura Lotz, Dr. med.

CONTACT

[email protected]

+49 9131 85 44023

Ralf Dittrich, Prof.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital Erlangen

Other

Collaborators

  • Roche Diagnostics International AG

Registry information

Official study title

Polycystic Ovarian Syndrome (PCOS) in Human Adolescent and Young Adult Females - Biomarker Evaluation Study (PHOEBE)

Acronym: PHOEBE

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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