A Phase 2, Randomized, Multicenter, Double-blind, Vehicle-controlled Study to Evaluate Safety and Efficacy of Three Doses of Estradiol Vaginal Capsule in Postmenopausal Women With Vulvovaginal Atrophy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 203
- 试验地点
- 17
- 主要终点
- Change in the percentage of vaginal superficial cells
研究概览
简要总结
This study will access the safety and efficacy of three doses of estradiol vaginal capsules in postmenopausal women with vulvovaginal atrophy.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of vulvovaginal atrophy due to post menopause
- •Age ≥ 40 years or if bilateral oophorectomy ≥ 35 years
- •Moderate to severe vaginal dryness
- •Normal breast exam; if > 40 years
- •Vaginal pH > 5.0
- •< 5% superficial cells on vaginal wall cytology smear
排除标准
- •Known hypersensitivity to estrogen and/or progestin therapy
- •Known or suspected premalignant or malignant disease
- •Undiagnosed abnormal genital bleeding
- •A history of or treatment for significant cardiovascular disease, congestive heart failure, or stroke
- •Active or known protein C, protein S, or antithrombin deficient, or other known thrombophilic disorders or thromboembolic events
- •Increased frequency/severity headaches with estrogen therapy
- •Smokes ≥ 15 cigarettes/day
研究组 & 干预措施
Estradiol Vaginal Capsule 0.003 mg
Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
干预措施: Estradiol Vaginal Capsule (EVC) (Drug)
Estradiol Vaginal Capsule 0.01 mg
Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
干预措施: Estradiol Vaginal Capsule (EVC) (Drug)
Estradiol Vaginal Capsule 0.02 mg
Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
干预措施: Estradiol Vaginal Capsule (EVC) (Drug)
Placebo
Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change in the percentage of vaginal superficial cells
时间窗: Baseline (Week 0) to Final Visit (Week 6)
Change in the percentage of vaginal parabasal cells
时间窗: Baseline (Week 0) to Final Visit (Week 6)
Change in vaginal pH
时间窗: Baseline (Week 0) to Final Visit (Week 6)
次要结局
- Change in the investigator assessment of VVA measured by scoring the vaginal health in 5 categories using a 4-point scale(Baseline (Week 0) to Final Visit (Week 6))
- Change in subject's self-assessment of vaginal dryness reported as the most bothersome symptom(Baseline (Week 0) to Final Visit (Week 6))
- Change in subject's self-assessment of dyspareunia reported as the most bothersome symptom(Baseline (Week 0) to Final Visit (Week 6))
- Change in subject's self-assessment of dysuria(Baseline (Week 0) to Final Visit (Week 6))
- Change in subject's self-assessment of vaginal and/or vulvar irritation/itching(Baseline (Week 0) to Final Visit (Week 6))
- Change in subject's self-assessment of dyspareunia in patients where dyspareunia was not reported as the most bothersome symptom(Baseline (Week 0) to Final Visit (Week 6))
- Self-assessment by sexually active participants as to the presence or absence of vaginal bleeding(Baseline (Week 0) to Final Visit (Week 6))
- Change in subject's self-assessment of vaginal dryness in patients where vaginal dryness was not reported as the most bothersome symptom(Baseline (Week 0) to Final Visit (Week 6))