Menopausal Hormone Therapy for Women Living With HIV (HoT)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 105
- 试验地点
- 23
- 主要终点
- Change in vasomotor symptoms (VMS) frequency
研究概览
简要总结
Women living with HIV have been shown to experience more frequent and severe hot flashes and night sweats (collectively known as vasomotor symptoms) as compared to women living without HIV. This correlates with disturbed sleep, increased depressive symptoms, increased anxiety, worse mental function, interference with activities of daily living including work, and worse overall quality of life.
Hormone therapy is considered to be the most effective therapy for hot flashes and night sweats and the most appropriate choice to prevent bone loss at the time of menopause for women without HIV. However, the usefulness of hormone therapy has not been specifically studied in women living with HIV.
This trial is being done to see if:
- There is evidence to support the use of hormone therapy (estradiol with or without progesterone) for the treatment of hot flashes and night sweats in women living with HIV
- Hormone therapy improves mental function, mood, sleep, quality of life, bone health, heart health, and inflammation in women living with HIV
- Hormone therapy is safe and tolerable for women living with HIV
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Living with HIV
- •Assigned female sex at birth
- •Between the ages of 40 and 60 years
- •In the late menopausal transition (perimenopause) or early postmenopause
- •Experiencing hot flashes and/or night sweats
- •Willing and able to complete a daily diary
- •Does not have medical condition that would contraindicate hormone therapy
- •Not taking medications to treat hot flashes
- •Not taking medications that cannot be combined with hormone therapy
- •Receiving antiretrovirals (HIV medication) for more than 1 year
- •Not pregnant and willing and able to use at least non-hormonal birth control to prevent pregnancy
- •Willing and able to provide informed consent after discussion with the research staff
排除标准
- 未提供
研究组 & 干预措施
Arm B: Hormone Therapy Placebo
PARTICIPANTS WITH INTACT UTERUS: Transdermal placebo gel plus oral encapsulated placebo pill daily for 12 weeks.
PARTICIPANTS WITHOUT A UTERUS: Transdermal placebo gel alone daily for 12 weeks.
干预措施: Placebo for estradiol gel (Drug)
Arm B: Hormone Therapy Placebo
PARTICIPANTS WITH INTACT UTERUS: Transdermal placebo gel plus oral encapsulated placebo pill daily for 12 weeks.
PARTICIPANTS WITHOUT A UTERUS: Transdermal placebo gel alone daily for 12 weeks.
干预措施: Placebo for micronized progesterone (Drug)
Arm A: Hormone Therapy
PARTICIPANTS WITH INTACT UTERUS: Transdermal estradiol gel plus oral micronized progesterone daily for 12 weeks.
PARTICIPANTS WITHOUT A UTERUS: Transdermal estradiol gel daily for 12 weeks.
干预措施: Transdermal estradiol gel (Drug)
Arm A: Hormone Therapy
PARTICIPANTS WITH INTACT UTERUS: Transdermal estradiol gel plus oral micronized progesterone daily for 12 weeks.
PARTICIPANTS WITHOUT A UTERUS: Transdermal estradiol gel daily for 12 weeks.
干预措施: Micronized Progesterone (Drug)
结局指标
主要结局
Change in vasomotor symptoms (VMS) frequency
时间窗: From 5 weeks prior to randomization to Week 12
Change in self-reported mean VMS frequency per day from 5-week observation phase prior to randomization to the one-week period prior to week 12 visit following.
次要结局
- Change in sexual function(From randomization to week 12)
- Percentage of participants with female sexual distress(Week 12 visit)
- Percentage of participants with adverse events associated with hormone therapy(From randomization to week 12)
- Change in vasomotor symptom (VMS) severity(From 5 weeks prior to randomization to week 12)
- Change in sleep(From randomization to week 12)
- Change in insomnia(From randomization to week 12)
- Change in quality of life(From randomization to week 12)
- Percentage of participants with occurrence of abnormal vaginal bleeding(From randomization to week 12)
- Percentage of participants with intolerance of hormone therapy(From randomization to week 12)
- Change in neurocognitive test results(From randomization to week 12)
- Change in depression symptoms(From randomization to week 12)
- Change in anxiety symptoms(From randomization to week 12)
- Change in weight(From randomization to week 12)
- Change in body mass index (BMI)(From randomization to week 12)
- Change in waist circumference(From randomization to week 12)
- Change in waist-to-hip ratio(From randomization to week 12)