NCT02049164终止2 期
A Randomized, Double-blind, Placebo-controlled, Forced Titration, Dose-ranging Study of AR08 in the Treatment of Vasomotor Symptoms (VMS) in Menopausal Females: A Proof-of-Concept Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 32
- 试验地点
- 15
- 主要终点
- Mean change from Baseline in the frequency and severity of moderate to severe hot flashes
研究概览
简要总结
The purpose of this study is to determine the effective dose or dose range of AR08 in the treatment of VMS in menopausal females.
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
- 41 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Generally healthy female > 40 years of age with a body mass index (BMI) ≤ 40;
- •Has undergone menopause defined as any of the following:
- •At least 12 months of spontaneous amenorrhea; or At least 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels > 40 mIU/mL; or At least 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy);
- •Experience a minimum of 7 moderate to severe hot flushes per day or 50 moderate to severe hot flushes per week
排除标准
- •Resting systolic blood pressure (SBP) <110 mmHg, resting diastolic blood pressure (DBP) <50 mm Hg, or a resting heart rate (HR) <60 beats per minute while awake;
- •Subjects with pre-existing orthostatic hypotension at Screening;
- •Use of oral estrogen-, progestin-, androgen-, or selective estrogen receptor modifier (SERM) -containing drug products within 8 weeks prior to Screening; use of transdermal hormone products within 8 weeks prior to Screening; use of vaginal hormone products (rings, creams, gels) within 4 weeks prior to Screening; use of intrauterine progestins within 8 weeks prior to Screening; use of progestin implants or estrogen injectables within 3 months prior to Screening; use of estrogen pellet or progestin injectables within 6 months prior to Screening;
- •History of daily usage (at least 28 days/month) of either of the following during the month prior to initiation of Screening: Antihypertensives or Prophylactic antimigraine medications
研究组 & 干预措施
AR08 0.5 mg/day
Experimental
AR08 QD oral dosing for 14 weeks
干预措施: AR08 (Drug)
AR08 1.0 mg/day
Experimental
AR08 QD oral dosing for 14 weeks
干预措施: AR08 (Drug)
AR08 2.0 mg/day
Experimental
AR08 QD oral dosing for 14 weeks
干预措施: AR08 (Drug)
Placebo
Placebo Comparator
Placebo QD oral dosing for 14 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Mean change from Baseline in the frequency and severity of moderate to severe hot flashes
时间窗: Weeks 4 and 12
次要结局
- Patient Global Impression - Improvement (PGI-I)(Weeks 4, 8, and 12)
研究者
研究点 (15)
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