NCT03306459Unknown不适用
Hospital Clínic Barcelona
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Quality of Life
研究概览
简要总结
A prospective assessment of psychological characteristics, quality of life and sexuality in naïve patients.
详细描述
This project with PCOS patients include an assessment of quality of life and sexuality in naïve patients.
Hypothesizing that PCOS women would show higher rates of psychological alterations, this study is aimed to investigate the association between polycystic ovary syndrome (PCOS) and psychological disturbances, including anger and to analyze whether the biochemical/phenotypical features of PCOS may play a role in the type and severity of psychological disorders.
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
- 16 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •PCOS patients without gestational desire who met the following criteria
- •Oligomenorrhea (cycles lasting >35 days) or amenorrhea (no periods in 6 months)
- •Hyperandrogenemia/hyperandrogenism Hirsutism Ferriman-Gallwey score > 12 Obvious acne or pronounced alopecia Androgen levels over normal female range
排除标准
- •Prior psychiatric diagnosis
- •Current use of psychiatric medications
- •Difficulties with language comprehension in case of non-nationals.
- •Yatrogenic hirsutism,
- •Other endocrine deseases with hyperandrogenism or that may influence the final results Ovarian or adrenal neoplasia Prolactinoma Cushing's syndrome Congenital adrenal hyperplasia Diabetes mellitus Thromboembolic disease
- •Patients who had received any drug therapy for hirsutism over the last 6 months
结局指标
主要结局
Quality of Life
时间窗: january 9th 2018-january 9th 2019
results of SF-36
次要结局
- Anger and aggressiveness(january 9th 2018-january 9th 2019)
- Sexuality(january 9th 2018-january 9th 2019)
- Psychological distress(january 9th 2018-january 9th 2019)
研究者
Camil Castelo-Branco
Professor
Hospital Clinic of Barcelona
研究点 (1)
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