Polycystic Ovarian Syndrome (PCOS) in Human Adolescent and Young Adult Females - Biomarker Evaluation Study (PHOEBE)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University Hospital Erlangen
- Enrollment
- 380
- Locations
- 1
- Primary Endpoint
- The validation of new potential biomarkers for aid in the diagnoisis of PCOS in adolescent and young adult women
Study Overview
Brief Summary
The purpose of the study is to validate recently identified biomarkers for the identification of PCOS in adolecent and young adult women.
Detailed 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 15 Years to 25 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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)
Outcomes
Primary Outcomes
The validation of new potential biomarkers for aid in the diagnoisis of PCOS in adolescent and young adult women
Time Frame: Baseline
Secondary Outcomes
No secondary outcomes reported
Investigators
Laura Lotz
PD Dr. med.
University Hospital Erlangen