A Randomized, Double-Blind, Vehicle-Controlled Study of the Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in the Treatment of Symptoms of Vulvovaginal Atrophy in Postmenopausal Women
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 722
- 试验地点
- 67
- 主要终点
- Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Week 12/Final Visit
研究概览
简要总结
Study if WC3011 is effective and safe in the treatment of postmenopausal vaginal dryness due to 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
- 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
- •Postmenopausal females ≥35 years with either or both ovaries removed or naturally menopausal with moderate to severe vaginal dryness
排除标准
- •Hypersensitivity to estrogen and/or progestin therapy
- •Known or suspected premalignant or malignant disease (except successfully treated skin cancers)
- •Manifestation of or treatment for significant cardiovascular disease, congestive heart failure, stroke or ischemic attacks
- •Insulin-dependent diabetes mellitus
- •Increased frequency or severity of headaches while on hormone or estrogen therapy
- •Drug or alcohol addiction within last 2 years
- •Participation in a clinical trial within 30 days
- •Smoking ≥ 15 cigarettes daily
- •Uncontrolled hypertension - systolic blood pressure (BP) ≥ 160 mmHg or diastolic BP ≥ 95 mmHg
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 daily for 2 weeks, followed by dosing 2 times a week for 10 weeks.
干预措施: Vehicle (Drug)
WC3011 Estradiol Vaginal Cream (3 Times/Week)
WC3011 estradiol vaginal cream applied daily for 2 weeks, followed by dosing 3 times a week for 10 weeks.
干预措施: WC3011 Estradiol Vaginal Cream (Drug)
Vehicle (3 Times/Week)
Vehicle applied daily for 2 weeks, followed by dosing 3 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 Week 12/Final Visit
时间窗: Baseline (Day 0) to Week 12/Final Visit
The severity of vaginal dryness was assessed and recorded on a questionnaire by the participants using the following 4 point scale where, 0=None (The symptom is not present), 1=Mild (The symptom is present but may be intermittent; does not interfere with participants activities or lifestyle), 2=Moderate (The symptom is present. Participant is usually aware of the symptom, but activities and lifestyle are only occasionally affected), and 3=Severe (The symptom is present. Participant is usually aware and bothered by the symptom and have modified participant's activities and/or lifestyle due to the symptom. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Change From Baseline in Vaginal pH to Week 12/Final Visit
时间窗: Baseline (Day 0) to Week 12/Final Visit
Vaginal pH was obtained at final visit of the study. The pH was a numeric value from a scale of 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. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Change From Baseline in Percentage of Vaginal Superficial Cells to Week 12/Final Visit
时间窗: Baseline (Day 0) to Week 12/Final Visit
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. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Change From Baseline in Percentage of Vaginal Parabasal Cells to Week 12/Final Visit
时间窗: Baseline (Day 0) to Week 12/Final Visit
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. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
次要结局
- Change From Baseline in Investigator's Assessment of Atrophy to Week 12 and Week 12/Final Visit(Baseline (Day 0) to Week 12 and Week 12/Final visit)
- Change From Baseline in Investigator's Assessment of Pallor to Week 12 and Week 12/Final Visit(Baseline (Day 0) to Week 12 and Week 12/Final visit)
- Change From Baseline in Investigator's Assessment of Vaginal Dryness to Week 12 and Week 12/Final Visit(Baseline (Day 0) to Week 12 and Week 12/Final visit)
- Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity as Per Participant's Self-Assessment to Weeks 2, 4, 8, 12 and Week 12/Final Visit(Baseline (Day 0) and Weeks 2, 4, 8, 12 and Week 12/Final visit)
- Change From Baseline in Percentage of Vaginal Superficial Cells to Week 12(Baseline (Day 0) to Week 12)
- Change From Baseline in Investigator's Assessment of Friability to Week 12 and Week 12/Final Visit(Baseline (Day 0) to Week 12 and Week 12/Final visit)
- Change From Baseline in Investigator's Assessment of Petechiae to Week 12 and Week 12/Final Visit(Baseline (Day 0) to Week 12 and Week 12/Final visit)
- 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 Participant's Self-Assessment of Dyspareunia (Pain Associated With Sexual Activity) to Weeks 2, 4, 8, 12 and Week 12/Final Visit(Baseline (Day 0) to Weeks 2, 4, 8, 12 and Week 12/Final visit)
- Change From Baseline in Participant's Self-Assessment of Vaginal and/or Vulvar Irritation/Itching to Weeks 2, 4, 8, 12 and Week 12/Final Visit(Baseline (Day 0) to Weeks 2, 4, 8, 12 and Week 12/Final visit)
- Change From Baseline in Vaginal pH to Week 12(Baseline (Day 0) to Week 12)
- Change From Baseline in Participant's Self-Assessment of Dysuria (Painful or Difficult Urination) to Weeks 2, 4, 8, 12 and Week 12/Final Visit(Baseline (Day 0) to Weeks 2, 4, 8, 12 and Week 12/Final visit)
- Change From Baseline in Percentage of Vaginal Parabasal Cells to Week 12(Baseline (Day 0) to Week 12)