A Randomized, Multicenter, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of WC3011 in Postmenopausal Women
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 576
- 试验地点
- 1
- 主要终点
- Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Final Assessment
研究概览
简要总结
The primary objective of this study is to compare the efficacy of WC3011 with placebo vaginal gel in postmenopausal women for the relief of vaginal dryness caused by vaginal atrophy as measured by self-assessment, vaginal pH and vaginal smear.
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
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Moderate to severe vaginal dryness
- •Postmenopausal meeting one of the following: 12 months spontaneous amenorrhea, 6 months spontaneous amenorrhea with serum Follicle-stimulating hormone (FSH) > 40 milli-International Unit (mIU)/mL, 6 weeks postsurgical bilateral oophorectomy confirmed by surgical report, ultrasound or serum FSH > 40 mIU/mL, 6 weeks postsurgical hysterectomy with ovary failure confirmed by serum FSH > 40 mIU/mL
- •Age ≥ 40 years or if bilateral oophorectomy ≥ 35 years
- •Vaginal pH >5.0
- •Less than or equal 5% superficial cells on vaginal wall cytologic smear
- •Normal breast exam; if > 40 years, documentation of negative mammogram
排除标准
- •Randomization in PR-04409, participation in clinical trial or use of investigational drug within 30 days prior to screening
- •Smokes ≥ 15 cigarettes/day
- •Known or suspected premalignant or malignant disease
- •Cardiovascular disease, insulin-dependent diabetes mellitus, congestive heart failure, stroke or ischemic attack, thrombophlebitis or thromboembolic disorder
- •Increased frequency/severity headaches with estrogen therapy
- •Drug addiction/alcohol abuse within last 2 years
- •Currently taking St. John's Wort or anticoagulant
- •Uncontrolled hypertension or thyroid disorder, clinically significant depression or untreated urinary tract infection
研究组 & 干预措施
WC3011 Estradiol Vaginal Cream (2 Times/Week)
WC3011 estradiol vaginal cream applied daily for 2 weeks followed by dosing 2 times a week for 10 weeks.
干预措施: WC3011 Estradiol Vaginal Cream (Drug)
Vehicle (2 Times/Week)
Vehicle applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks.
干预措施: Vehicle (Drug)
结局指标
主要结局
Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Final Assessment
时间窗: Baseline (Day 0) to final assessment (Up to Week 12)
Participant's self-assessment of Vaginal Dryness was scored on a 4-point scale where: 0=none, 1=mild, 2=moderate or 3=severe. Higher scores indicate the most bothersome symptoms. A negative change from Baseline indicates improvement. Final assessment is defined as the last available postbaseline assessment.
Change From Baseline in the Percentage of Vaginal Superficial Cells to Final Assessment
时间窗: Baseline (Day 0) to final assessment (Up to Week 12)
Vaginal wall smears were collected from each participant. The smears were sent to the central laboratory for analysis to determine the percentage of superficial cells. A positive change from Baseline indicates improvement. Final assessment is defined as the last available postbaseline assessment.
Change From Baseline in Vaginal pH to Final Assessment
时间窗: Baseline (Day 0) to final assessment (Up to Week 12)
Vaginal pH was obtained at baseline and final visit of the study. The pH was a numeric value from 0 to 14 expressing the acidity or alkalinity of the vaginal fluids where 7 was neutral, lower values were more acidic (values of 0-6) and higher values more alkaline (values of 8-14). A negative change from Baseline indicates improvement. Final assessment is defined as the last available postbaseline assessment.
Change From Baseline in the Percentage of Vaginal Parabasal Cells to Final Assessment
时间窗: Baseline (Day 0) to final assessment (Up to Week 12)
Vaginal wall smears were collected from each participant. The smears were sent to the central laboratory for analysis to determine the percentage of parabasal cells. A negative change from Baseline indicates improvement. Final assessment is defined as the last available postbaseline assessment.
次要结局
- Change From Baseline in the Investigator's Assessment of Each of the Signs of VVA to Week 12 and Final Assessment(Baseline (Day 0) to Week 12 and Final Assessment)
- Change From Baseline in the Percentage of Vaginal Parabasal Cells to Week 12(Baseline (Day 0) to Week 12)
- Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Weeks 2, 4, 8, and 12(Baseline (Day 0) to Weeks 2, 4, 8, and 12)
- Change From Baseline in Participants Self-Assessment of the Symptoms of VVA(Baseline (Day 0) to Weeks 2, 4, 8, 12 and Final Assessment)
- Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity(Baseline (Day 0) and Weeks 2, 4, 8, 12 and Final Assessment)
- Change From Baseline in the Percentage of Vaginal Superficial Cells to Week 12(Baseline (Day 0) to Week 12)