A Phase IIa, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Examine MK-6913 for the Treatment of Vasomotor Symptoms in Postmenopausal Women
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 99
- 主要终点
- Number of Participants Who Experienced at Least One or More Adverse Events (AE)
研究概览
简要总结
This study will assess the safety, tolerability, and efficacy of MK-6913 for the treatment of moderate-to-very-severe vasomotor symptoms (hot flashes or hot flushes) in postmenopausal women. The primary study hypothesis is that one or more doses of MK-6913 will result in a significantly greater reduction from baseline, compared to placebo, in the number of moderate to very severe hot flashes after 4 weeks of 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Woman with at least 50 moderate to very severe hot flash episodes per week
- •Postmenopausal
- •Between 45 and 60 years of age if naturally menopausal, or between 35 and 60 if she underwent a bilateral oophorectomy
- •Not receiving hormone therapy
- •Has had both a normal mammogram and a normal Pap test in the past 6 months
- •Generally healthy
排除标准
- •A history of cancer, except for certain skin cancers
- •Undiagnosed vaginal bleeding or any uterine endometrial disorder
- •Currently uses tobacco products, or has used them in the last 6 months
- •Has human immunodeficiency virus (HIV)
研究组 & 干预措施
MK-6913 75 mg
MK-6913 75 mg capsule and matching placebo for 17β-estradiol 1 mg tablet once daily for 4 weeks (Stage 1 and Stage 2)
干预措施: MK-6913 (Drug)
MK-6913 75 mg
MK-6913 75 mg capsule and matching placebo for 17β-estradiol 1 mg tablet once daily for 4 weeks (Stage 1 and Stage 2)
干预措施: Placebo to 17-β estradiol (Drug)
17-β estradiol 1 mg
17β-estradiol 1 mg tablet and matching placebo for MK-6913 75 mg capsule once daily for 4 weeks (Stage 1 and Stage 2)
干预措施: 17-β estradiol (Drug)
17-β estradiol 1 mg
17β-estradiol 1 mg tablet and matching placebo for MK-6913 75 mg capsule once daily for 4 weeks (Stage 1 and Stage 2)
干预措施: Placebo to MK-6913 (Drug)
Placebo
Matching placebo for MK-6913 75 mg capsule and matching placebo for 17β-estradiol 1 mg tablet once daily for 4 weeks (Stage 1 and State 2)
干预措施: Placebo to MK-6913 (Drug)
Placebo
Matching placebo for MK-6913 75 mg capsule and matching placebo for 17β-estradiol 1 mg tablet once daily for 4 weeks (Stage 1 and State 2)
干预措施: Placebo to 17-β estradiol (Drug)
MK-6913 25 mg
MK-6913 25 mg capsule and matching placebo for 17β-estradiol 1 mg tablet once daily for 4 weeks (Stage 2)
干预措施: MK-6913 25 mg (Drug)
结局指标
主要结局
Number of Participants Who Experienced at Least One or More Adverse Events (AE)
时间窗: Up to 6 weeks
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Number of Participants Who Discontinued Study Drug Due to an AE
时间窗: Up to 4 weeks
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Percent Change From Baseline in the Number of Weekly Moderate to Very Severe Hot Flashes (Excluding Outliers) at Week 4
时间窗: Baseline and Week 4
Hot flashes were recorded in real time and hot flashes recorded retrospectively in the morning and evening reports in a diary day via the Hot Flash e-diary were summed to determine the total number of hot flashes over a diary day. The total number of weekly moderate or worse hot flashes were calculated as the sum of the total number of hot flashes that occur over a diary week (non-missing diary day), divided by the number of days of diary completion, and multiplied by 7 (standardized week). At least 4 non-missing diary days were required to define the total number of weekly moderate or worse hot flashes. Hot flash data was excluded for participants whose number of moderate to severe hot flashes per week were in the top 1% of number of hot flashes reported to exclude any outlier effect.
次要结局
- Percent Change From Baseline in the Weekly Hot Flash Severity Score (Combining Severe and Very Severe Score) at Week 4(Baseline and Week 4)
- Change From Baseline in Follicle-stimulating Hormone (FSH) Level at Week 4(Baseline and Week 4)