MsFLASH-03: Comparative Efficacy of Low-Dose Estradiol and the SNRI Venlafaxine XR for Treatment of Menopausal Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 339
- 试验地点
- 4
- 主要终点
- Frequency of Hot Flashes (Vasomotor Symptom [VMS] Frequency) -- Week 4
研究概览
简要总结
The primary objective of this study is to determine the efficacy of both low-dose oral (by mouth) 17-ß-estradiol and the non-hormonal drug venlafaxine XR compared to placebo in reducing hot flashes. Included in this objective is the intention to compare venlafaxine XR to estradiol therapy, to provide evidence of the relative efficacy of venlafaxine to what is currently considered the most established but also a controversial therapy. 17-ß-estradiol is a type of estrogen. Venlafaxine XR is the extended release (XR) version of venlafaxine. Venlafaxine XR is an serotonin-norepinephrine reuptake inhibitor (SNRI). A placebo is a substance containing no medication.
详细描述
The MsFLASH-03 study (Menopausal Strategies: Finding Lasting Answers for Symptoms and Health - 03), Comparative Efficacy of Low-Dose Estradiol and the SNRI Venlafaxine XR for Treatment of Menopausal Symptoms, is a randomized, double-blind, placebo-controlled, three arm clinical trial. The design includes: 3 weeks of daily recording of hot flashes prior to drug treatment; 8 weeks of double-blind treatment with oral estradiol, venlafaxine, or placebo; followed by 14 days of drug taper for those on venlafaxine and 14 days of progesterone treatment for those on estradiol; followed by 2 weeks with no treatment for all groups; and a telephone follow-up post-treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 62 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females aged 40-62 years
- •Postmenopausal or perimenopausal
- •Having bothersome hot flashes
- •In general good health
- •Signed informed consent
排除标准
- •Recent use of systemic hormone therapy or hormonal contraceptives
- •Recent use of any prescribed, over-the-counter or herbal therapies that are taken specifically for hot flashes
- •Recent use of selective estrogen receptor modulators (SERMS) or aromatase inhibitors
- •Recent use of psychotropic medications, including SSRIs (selective serotonin reuptake inhibitors), serotonin-norepinephrine reuptake inhibitors (SNRIs), MAOIs (monoamine oxidase inhibitors), and other antidepressants and anxiolytics.
- •Known hypersensitivity or contraindications (reasons not to take) to venlafaxine, estrogen, or progestins
- •Not using a medically approved method of birth control, if sexually active and not 12 or more months since last menstrual period
- •Recent drug or alcohol abuse
- •Lifetime diagnosis of psychosis or bipolar disorder
- •Suicide attempt in the past 3 years or any current suicidal ideation
- •Current major depression (assessed during screening)
- •Pregnancy, intending pregnancy, or breast feeding
- •History of:
- •Pre-breast cancer or high-risk breast cancer condition
- •Abnormal bleeding suggestive of endometrial pre-cancer or endometrial hyperplasia
- •Asthma, diabetes mellitus, epilepsy, and migraine disorders that are not stable or under medical management
- •Abnormal screening blood tests
- •Current participation in another drug trial or intervention study
- •Inability or unwillingness to complete the study procedures
研究组 & 干预措施
Low-dose 17-ß-estradiol with progesterone taper
干预措施: Low-dose 17-ß-estradiol with progesterone taper (Drug)
Venlafaxine XR
干预措施: Venlafaxine XR (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Frequency of Hot Flashes (Vasomotor Symptom [VMS] Frequency) -- Week 4
时间窗: Week 4
Measured by self-report diary twice daily (day and night). The day and night frequencies were summed to produce a single number of hot flashes per day. The single number of hot flashes per day were summed and averaged for one week prior to the week 4 study assessment to produce a mean daily frequency for week 4.
Frequency of Hot Flashes (Daily Vasomotor Symptom [VMS] Frequency) -- Week 8
时间窗: Week 8
Measured by self-report diary twice daily (day and night). The day and night frequencies were summed to produce a single number of hot flashes per day. The single number of hot flashes per day were summed and averaged for one week prior to the week 8 study assessment to produce a mean daily frequency for week 8.
次要结局
- Severity of Hot Flashes -- Week 4(Week 4)
- Severity of Hot Flashes -- Week 8(Week 8)
- Bothersomeness of Hot Flashes -- Week 4(Week 4)
- Bothersomeness of Hot Flashes -- Week 8(Week 8)
- Perceived Hot Flash Interference (Hot Flash Related Daily Interference Scale; HFRDIS) -- Week 4(Week 4)
- Perceived Hot Flash Interference (Hot Flash Related Daily Interference Scale; HFRDIS) -- Week 8(Week 8)
研究者
Katherine Guthrie
Principal Investigator
Fred Hutchinson Cancer Center