Premenstrual Hormonal and Affective State Evaluation (PHASE) Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 2
- 主要终点
- Hormone Analysis
研究概览
简要总结
PHASE is designed to evaluate neuroactive hormone trajectories across the menstrual cycle and endocrine, autonomic, and subjective responses to psychosocial stress in women suffering from severe PMS (i.e., premenstrual dysphoric disorder).
详细描述
Female volunteers will be recruited from the community for participation in this 3-menstrual cycle study. In the first two menstrual cycles, study participants will chart their symptoms and and ovulation. Study participants will continue to perform ovulation testing during their third menstrual cycle in which they will attend one individualized task session and provide 8 serum samples at different timepoints across the menstrual cycle. Primary analyses will contrast neuroactive hormone trajectories across the menstrual cycle and stress reactivity according to study groups (PMDD vs healthy).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Aged 18-35 years, established by visual inspection of a government-issued ID
- •Average menstrual cycle 21-35 days
排除标准
- •Lifetime DSM-5 Axis 1 disorder (except anxiety and depression), as documented in the Mental Health Interview
- •Current DSM-5 Axis depressive or anxiety disorder, as documented in the Mental Health Interview
- •Positive urine drug screen test
- •Breath alcohol concentration >0.00%
- •Self-reported smoker or carbon monoxide concentration ≥ 6 ppm
- •Irregular menstrual cycle
- •Current pregnancy (urine test-verified) or lactation, or a plan to become pregnant
- •Moderate or high suicide risk
- •Shipley IQ (vocabulary standard score) > 80
- •Any prescription medications (including hormonal forms of birth control)
研究组 & 干预措施
All Participants
干预措施: Individualized laboratory test (Procedure)
结局指标
主要结局
Hormone Analysis
时间窗: -20, +20, +30, +40, +50, +65, +90 minutes in the late luteal phase of the menstrual cycle (one day between -1 to -6 days of the subsequent menstrual cycle)
Cortisol
次要结局
未报告次要终点
研究者
Ajna Hamidovic, PharmD, MS
Assistant Professor
University of Illinois at Chicago