Polycystic Ovarian Syndrome (PCOS) in Human Adolescent and Young Adult Females - Biomarker Evaluation Study (PHOEBE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 380
- 试验地点
- 1
- 主要终点
- The validation of new potential biomarkers for aid in the diagnoisis of PCOS in adolescent and young adult women
研究概览
简要总结
The purpose of the study is to validate recently identified biomarkers for the identification of PCOS in adolecent and young adult women.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 25 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female subjects age 15-25 years
- •Signed written informed consent
排除标准
- •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)
结局指标
主要结局
The validation of new potential biomarkers for aid in the diagnoisis of PCOS in adolescent and young adult women
时间窗: Baseline
次要结局
未报告次要终点
研究者
Laura Lotz
PD Dr. med.
University Hospital Erlangen