NCT00421031已完成3 期
A Double-Blind, Randomized, Placebo-Controlled Efficacy and Safety Study of DVS-233 SR For Relief of Vasomotor Symptoms Associated With Menopause
Wyeth is now a wholly owned subsidiary of Pfizer41 个研究点 分布在 1 个国家目标入组 540 人开始时间: 2003年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 540
- 试验地点
- 41
- 主要终点
- The primary objective is to assess the efficacy and safety of 4 doses of DVS-233 SR as compared to placebo for the treatment of moderate to severe VMS associated with menopause.
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of 4 doses of desvenlafaxine-233 sustained release (DVS-233 SR) as compared to placebo for the treatment of moderate to severe vasomotor symptoms associated with menopause, as well as its influence on sleep parameters and other health outcomes indicators.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Generally healthy, postmenopausal women; at least 12 months of spontaneous amenorrhea or at least 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL or at least 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy).
- •Minimum of 7 moderate to severe hot flushes per day or 50 moderate to severe hot flushes per week at screening:
- •Moderate hot flush: warm sensation with sweating, does not disrupt activity.
- •Severe hot flush: hot sensation with sweating, disrupts activity.
- •Subjects must have body mass index (BMI) less than or equal to 40 using the nomograph for BMI.
排除标准
- •Hypersensitivity to venlafaxine (Effexor or Effexor XR).
- •Use of oral estrogen-, progestin-, androgen-, or 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 a seizure disorder other than a single childhood febrile seizure.
结局指标
主要结局
The primary objective is to assess the efficacy and safety of 4 doses of DVS-233 SR as compared to placebo for the treatment of moderate to severe VMS associated with menopause.
次要结局
- The secondary objectives are to assess the effects of DVS-233 SR as compared to placebo on sleep parameters and on health outcomes indicators
研究者
研究点 (41)
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