Steroid Profiling in Adolescents and Young Women With PCOS: Effects of Oral Contraceptive Therapy Assessed by LC-MS/MS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Serum adrogen levels
研究概览
简要总结
This prospective observational study investigates the changes in serum steroid intermediates assessed by liquid chromatography-mass spectrometry (LC-MS/MS) in adolescents and young women with polycystic ovary syndrome (PCOS), before and after oral contraceptive (OCP) treatment.
详细描述
The study enrolled 56 female patients aged 13-21 years with a diagnosis of PCOS according to Rotterdam criteria. At baseline, all participants underwent LC-MS/MS steroid profiling. A subgroup of 15 patients received oral contraceptive therapy based on clinical indication, independent of the study protocol. A second LC-MS/MS steroid analysis was performed at 6 months in this subgroup. The primary aim was to investigate the effect of OCP on the steroid biosynthesis profile. The study was approved by the Istanbul University Ethics Committee (Approval ID: 2019/822) and conducted between January 2020 and December 2021.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 13 Years 至 21 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of PCOS based on Rotterdam criteria
- •Age between 13 and 21 years
- •No hormonal treatment in the 3 months prior to study enrollment
- •Consent provided
排除标准
- •Congenital adrenal hyperplasia
- •Cushing's syndrome
- •Pregnancy
- •Use of hormonal medications within 1 year prior to baseline
结局指标
主要结局
Serum adrogen levels
时间窗: 6 months
Change in serum androgen levels (e.g., testosterone, androstenedione, DHEAS) measured by LC-MS/MS between baseline and 6 months in the OCP-treated group.
serum androgen levels
时间窗: 6 months
Change in serum androgen levels (e.g., testosterone, androstenedione, DHEAS) measured by LC-MS/MS between baseline and 6 months in the OCP-treated group.
次要结局
- Change in serum steroid hormone levels after 6 months of OCP treatment in adolescents with PCOS(Baseline and 6 months after the initiation of OCP treatment)
研究者
Ozge Bayrak Demirel
Pediatric Endocrinologist
Istanbul University