NCT04853472已完成不适用
Menopause Sample Collection
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 1
- 主要终点
- Number of daily urine samples collected from women during various stages of the menopause
研究概览
简要总结
This study will provide daily urine samples from women during early and late stage peri-menopause as well as post-menopause over the course of three calendar months in order to maintain the SPD sample bank.
Urine samples will be received in the clinical laboratory and aliquoted into 2.25ml amounts and stored at -80˚C until required.
Symptom information will also be recorded to determine whether there are any noticeable physiological changes that can be related to stage of the menopause.
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
- 45 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Between the ages of 45 and 60 years
- •Suspects they are going through or have been through the menopause
- •Experiencing cycle irregularities:
- •Early Stage Peri-Menopause: Mild cycle irregularity over the last 3-6months (minimum), variation of >6 days in length between consecutive cycles including shortened and longer cycles (but not >60 days in length)
- •Late stage peri-menopause: Irregular cycles with prolonged periods of amenorrhea >60 days in length (but less than 12 months)
- •Post-Menopause: Greater than 12 months since last menstrual period
- •Willing to give informed consent
排除标准
- •Use of hormone replacement therapy (HRT)
- •Use of hormone contraception
- •Hysterectomy and/or oophorectomy
- •Pregnant or breast feeding
- •Other medical reason for amenorrhea (absence of menstruation)
结局指标
主要结局
Number of daily urine samples collected from women during various stages of the menopause
时间窗: 3 months
Daily urine samples collected
次要结局
- Menopause Symptom Information(3 months)
研究者
研究点 (1)
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