NCT00566982已完成3 期
Efficacy and Long-Term Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women: A 52-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing 60 MG Oral Daily Dose of Ospemifene With Placebo
Shionogi0 个研究点目标入组 426 人开始时间: 2007年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 426
- 主要终点
- Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear
研究概览
简要总结
The purpose of this study is to determine the efficacy and long-term safety of 60mg ospemifene in the treatment of VVA in postmenopausal women with intact uterus.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Naturally or surgically menopausal
- •Intact uterus
- •Vaginal pH greater than 5.0
- •5% or fewer superficial cells in maturation index of vaginal smear
排除标准
- •Evidence of endometrial hyperplasia, cancer or other pathology
- •Abnormal Pap smear
- •Uterine bleeding of unknown origin or uterine polyps
- •Current vaginal infection requiring medication
- •Use of hormonal medications
- •Clinically significant abnormal gynecological findings other than signs of vaginal atrophy
研究组 & 干预措施
Ospemifene 60 mg/day
Experimental
Ospemifene will be taken orally, once daily, in the morning, with food for 52 weeks.
干预措施: Ospemifene 60 mg (Drug)
Placebo
Placebo Comparator
Placebo will be taken once daily, in the morning, with food for 52 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear
时间窗: 12 weeks
Mean Change From Baseline in Percentage of Superficial Cells in Maturation Index of Vaginal Smear
时间窗: 12 weeks
Mean Change From Baseline in Vaginal pH
时间窗: 12 weeks
次要结局
- Change From Baseline in Estradiol Levels(52 weeks)
- Change From Baseline in Luteinizing Hormone Levels(52 weeks)
- Change From Baseline in Follicle Stimulating Hormone Levels(52 weeks)
- Change From Baseline in Sex Hormone Binding Globulin Levels(52 weeks)
- Visual Evaluation of the Vagina (Baseline & Week 52)(52 weeks)
研究者
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进行中（未招募）
不适用
Efficacy and long-term safety of Ospemifene in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women: A 52-week, randomized, double-blind, placebo-controlled, parallel-group study comparing 60 mg oral daily dose of Ospemifene with placebo.Vulvar and vaginal atrophyMedDRA version: 9.1Level: LLTClassification code 10047782Term: Vulvovaginal atrophyEUCTR2007-002939-90-SEHormos Medical Ltd350