A Multicenter, Open-Label Extension Study to Evaluate the Long-Term 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
- 309
- 试验地点
- 62
- 主要终点
- Number of Participants With Endometrial Biopsy Results at Final Visit
研究概览
简要总结
This is an open-label extension study evaluating the long-term safety and efficacy of WC3011 in non-hysterectomized, healthy, postmenopausal women with vulvovaginal atrophy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Completed Study PR-04409.3 (NCT01400776)
排除标准
- •Developed any of the following during Study-PR04409.3 or has begun taking hormone therapy other than WC3011:
- •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, stroke or ischemic attack
- •Insulin-dependent diabetes mellitus
- •Smoking ≥ 15 cigarettes daily
- •Uncontrolled hypertension - systolic blood pressure (BP) ≥ 160 mmHG or diastolic ≥ 95 mmHg
研究组 & 干预措施
WC3011 Estradiol Vaginal Cream
WC3011 estradiol vaginal cream 3 times a week for up to 40 weeks.
干预措施: WC3011 Estradiol Vaginal Cream (Drug)
结局指标
主要结局
Number of Participants With Endometrial Biopsy Results at Final Visit
时间窗: Final Visit (Day closest to Day 281)
The endometrial biopsy results was categorized as: normal results categorized as atrophic/inactive or proliferative, unsatisfactory with endometrial thickness ≤4 mm and missing biopsy with endometrial thickness ≤4 mm; abnormal results categorized as polyp, hyperplasia, and carcinoma; unknown result categorized as unsatisfactory with endometrial thickness \>4 mm, missing biopsy with endometrial thickness \>4 mm, unsatisfactory without transvaginal ultrasonography (TVU) result and missing biopsy without TVU result. The duration of estradiol exposure was combination of studies PR-04409.3 and PR-04509.
次要结局
- Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints(Baseline (Baseline/Visit 1 for this study was the same as Final Visit/Visit 5 for completers of PR-04409.3) to Weeks 4, 8, 16, 24, 32, 40 and Final Visit (Day closest to Day 281))
- Change From Baseline in Vaginal Cytology: Percentage of Superficial Vaginal Cells(Baseline (Baseline/Visit 1 for this study was the same as Final Visit/Visit 5 for completers of PR-04409.3) to Week 40 and Final Visit (Day closest to Day 281))
- Change From Baseline in Vaginal Cytology: Percentage of Parabasal Vaginal Cells(Baseline (Baseline/Visit 1 for this study was the same as Final Visit/Visit 5 for completers of PR-04409.3) to Week 40 and Final Visit (Day closest to Day 281))
- Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA(Baseline (Baseline/Visit 1 for this study was the same as Final Visit/Visit 5 for completers of PR-04409.3) to Week 40 and Final Visit (Day closest to Day 281))
- Change From Baseline in Vaginal pH(Baseline (Baseline/Visit 1 for this study was the same as Final Visit/Visit 5 for completers of PR-04409.3) to Week 40 and Final Visit (Day closest to Day 281))
- Number of Participants With At Least One Treatment Emergent Adverse Event (TEAE)(Up to Week 40)