Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women: A Phase II Dose Ranging, 12-Week, Randomized , Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Oral Ospemifene 5 mg, 15 mg and 30 mg Daily Doses With Placebo
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 主要终点
- Mean Change From Baseline in Percentage of Superficial Cells in Maturation Index of the Vaginal Smear
研究概览
简要总结
The purpose of the study is to assess the efficacy, safety and tolerability of Ospemifene 5 mg, 15 mg, and 30 mg in the treatment of VVA in postmenopausal women to find the minimum effective dose below the lowest dose of 30 mg tested earlier in Phase II.
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
- •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
Subjects on placebo
Subjects will self-administer 1 placebo tablet daily (in the morning with food) for 12 weeks
干预措施: Placebo (Drug)
Subjects on ospemifene 5 mg/day
Subjects will self-administer 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
干预措施: Ospemifene 5 mg (Drug)
Subjects on ospemifene 15 mg/day
Subjects will self-administer 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
干预措施: Ospemifene 15 mg (Drug)
Subjects on ospemifene 30 mg/day
Subjects will self-administer 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
干预措施: Ospemifene 30 mg (Drug)
结局指标
主要结局
Mean Change From Baseline in Percentage of Superficial Cells in Maturation Index of the Vaginal Smear
时间窗: 12 weeks
Mean Change From Baseline in Vaginal pH
时间窗: 12 weeks
Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear
时间窗: 12 weeks
次要结局
- Visual Evaluation of Vagina (by Gynecological Examination)(Screening & Week 12)
- Mean Change From Baseline in Vaginal pH(Week 4)
- Mean Change From Baseline in Percentage of Superficial Cells in the Maturation Index(Week 4)
- Mean Change From Baseline in Estradiol Levels(Week 12)
- Mean Change From Baseline in Luteinizing Hormone Levels(Week 12)
- Mean Change From Baseline in Follicle Stimulating Hormone Levels(Week 12)
- Mean Change From Baseline in Sex Hormone Binding Globulin Levels(Week 12)
- Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index(Week 4)