Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity, Symptoms of Vulvar and Vaginal Atrophy (VVA), Associated With Menopause: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Oral Ospemifene 60 mg Dose With Placebo in Postmenopausal Women
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 919
- 主要终点
- Change From Baseline to Week 12 in Vaginal pH (Dyspareunia Strata)
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of ospemifene in postmenopausal women experiencing moderate to severe vaginal dryness and vaginal pain associated with sexual activity.
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, Care Provider, Investigator)
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
- •Moderate or severe symptoms of vaginal atrophy
- •5% or fewer superficial cells in maturation index of vaginal smear
- •Vaginal pH greater than 5.0
- •Self reported Most Bothersome Symptom of vaginal dryness or vaginal pain associated with sexual activity, with a severity of moderate or severe at randomization
排除标准
- •Uterine bleeding of unknown origin, uterine polyps or symptomatic and/or large uterine fibroids
- •Current vaginal infection requiring medication
- •Clinically significant abnormal gynecological findings other than signs of vaginal atrophy (e.g.
- •uterine or vaginal prolapse of Grade 2 or higher)
- •Previous participation in any other ospemifene study
研究组 & 干预措施
Ospemifene 60 mg/day and K-Y® lubricant
Subjects will receive a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects will be provided vaginal lubricant (K-Y® Brand) and should use it as needed.
干预措施: Ospemifene 60 mg (Drug)
Placebo and K-Y® lubricant
Subjects will receive a single, oral dose (1 tablet) of Placebo each morning with food for 12 weeks. All subjects will be provided vaginal lubricant (K-Y® Brand) and should use it as needed.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline to Week 12 in Vaginal pH (Dyspareunia Strata)
时间窗: 12 weeks
Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata)
时间窗: 12 weeks
Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dryness Strata)
时间窗: 12 weeks
Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dryness Strata)
时间窗: 12 weeks
Change From Baseline to Week 12 in Vaginal pH (Dryness Strata)
时间窗: 12 weeks
Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata)
时间窗: 12 weeks
Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dyspareunia Strata)
时间窗: 12 weeks
Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dyspareunia Strata)
时间窗: 12 weeks
次要结局
- Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dryness Strata)(4 weeks)
- Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dryness Strata)(4 weeks)
- Change From Baseline to Week 4 in Vaginal pH (Dryness Strata)(4 weeks)
- Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata)(4 weeks)
- Change From Baseline to Week 4 in Vaginal pH (Dyspareunia Strata)(4 weeks)
- Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata)(4 weeks)
- Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dyspareunia Strata)(4 weeks)
- Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dyspareunia Strata)(4 weeks)