Understanding Experimentally Induced Hot Flushes and Their Impact on Sleep and Mood
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Percent Change in Objective Sleep Efficiency
研究概览
简要总结
The purpose of the study is to examine the impact of hot flushes on sleep, mood, and well-being. The investigators will cause hot flushes by giving study participants the hormone medication, leuprolide (Lupron), which is a manufactured (artificial) hormone that makes the body think that it has reached menopause temporarily. Most women begin to have hot flushes within 4 weeks after taking leuprolide and resume menses 3 months later. The investigators will administer questionnaires to evaluate changes in sleep and mood over the course of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women 18-45 years old
- •Premenopausal
- •Willingness to use barrier methods of contraception during study and after completion of study until menses resume
- •Good general health
排除标准
- •Pregnancy
- •Breastfeeding
- •Hot flushes
- •Hemoglobin at the screening visit less than 10 gm/dL
- •Abnormal liver function tests
- •Abnormal renal function tests
- •BMI > 35 kg/m2
- •Previously diagnosed osteoporosis or osteopenia
- •Psychiatric disorder involving mood, anxiety, psychotic disorder, current anorexia nervosa, or current alcohol or substance-use disorder
- •Previous severe depression
- •Evidence of suicidal or homicidal ideation
- •Sleep apnea, narcolepsy, or other diagnosed sleep disorder
- •Contraindication, hypersensitivity, or previous allergic reaction to GnRH agonists
- •Regular use of centrally active medications
- •Use of hormonal medications for at least 2 months
- •Use of ketoconazole, clomiphene citrate, or anabolic/androgenic steroids in the preceding 3 months
- •Renal insufficiency
- •Abnormal vaginal bleeding
- •History of thrombo-embolism or cardiovascular disease
- •History of congestive heart failure or other conditions requiring sodium restriction
- •History of spinal cord compression
- •Metastatic vertebral lesions
- •Memory disorders
- •Urinary tract obstruction
- •History of liver, kidney, pulmonary, or metabolic disease
研究组 & 干预措施
Developed hot flashes
Subjects who developed hot flashes after receiving leuprolide acetate (3.75 mg intramuscular injection)
干预措施: Leuprolide acetate (Drug)
Did not develop hot flashes
Subjects who did not develop hot flashes after receiving leuprolide acetate (3.75 mg intramuscular injection)
干预措施: Leuprolide acetate (Drug)
结局指标
主要结局
Percent Change in Objective Sleep Efficiency
时间窗: baseline (before receiving intervention) and 4 weeks after receiving intervention
Objective sleep efficiency was measured using actigraphy. Sleep efficiency (percent of time spent asleep between bedtime and wake time) was calculated and averaged over 2 consecutive nights both before and 4 weeks after receiving the intervention.
次要结局
- Change in Subjective Sleep Quality(baseline (before receiving intervention) and 4 weeks after receiving intervention)
研究者
Hadine Joffe, MD
Vice Chair for Psychiatry Research
Brigham and Women's Hospital