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Study to Evaluate Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in Postmenopausal Women With Dyspareunia

2022年4月11日 更新者：Warner Chilcott

A Randomized, Multicenter, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of WC3011 in Postmenopausal Women With Dyspareunia

The purpose of the study is to determine if WC3011 is safe and effective in treating the symptom of painful intercourse secondary to vulvovaginal atrophy as measured by participant self-assessment when compared to vehicle.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

550

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35211
        • Warner Chilcott Investigational Study Site
      • Mobile、Alabama、美国、36608
        • Warner Chilcott Investigational Study Site
    • Arizona
      • Chandler、Arizona、美国、85224
        • Warner Chilcott Investigational Study Site
      • Phoenix、Arizona、美国、85032
        • Warner Chilcott Investigational Study Site
      • Scottsdale、Arizona、美国、85251
        • Warner Chilcott Investigational Study Site
      • Tucson、Arizona、美国、85712
        • Warner Chilcott Investigational Study Site
      • Tucson、Arizona、美国、85710
        • Warner Chilcott Investigational Study Site
    • California
      • Sacramento、California、美国、95821
        • Warner Chilcott Investigational Study Site
      • San Diego、California、美国、92103
        • Warner Chilcott Investigational Study Site
      • San Diego、California、美国、92108
        • Warner Chilcott Investigational Study Site
      • San Diego、California、美国、92123
        • Warner Chilcott Investigational Study Site
    • Connecticut
      • New London、Connecticut、美国、06320
        • Warner Chilcott Investigational Study Site
    • District of Columbia
      • Washington、District of Columbia、美国、20036
        • Warner Chilcott Investigational Study Site
    • Florida
      • Boynton Beach、Florida、美国、33472
        • Warner Chilcott Investigational Study Site
      • Clearwater、Florida、美国、33759
        • Warner Chilcott Investigational Study Site
      • Jacksonville、Florida、美国、32216
        • Warner Chilcott Investigational Study Site
      • Miami、Florida、美国、33186
        • Warner Chilcott Investigational Study Site
      • Ormond Beach、Florida、美国、32174
        • Warner Chilcott Investigational Study Site
      • Palm Beach Gardens、Florida、美国、33410
        • Warner Chilcott Investigational Study Site
      • Pinellas Park、Florida、美国、33781
        • Warner Chilcott Investigational Study Site
      • West Palm Beach、Florida、美国、33409
        • Warner Chilcott Investigational Study Site
    • Georgia
      • Atlanta、Georgia、美国、30342
        • Warner Chilcott Investigational Study Site
      • Roswell、Georgia、美国、30075
        • Warner Chilcott Investigational Study Site
      • Savannah、Georgia、美国、31406
        • Warner Chilcott Investigational Study Site
    • Indiana
      • Granger、Indiana、美国、46530
        • Warner Chilcott Investigational Study Site
    • Kentucky
      • Lexington、Kentucky、美国、40509
        • Warner Chilcott Investigational Study Site
    • Louisiana
      • Marrero、Louisiana、美国、70072
        • Warner Chilcott Investigational Study Site
      • New Orleans、Louisiana、美国、70115
        • Warner Chilcott Investigational Study Site
    • Michigan
      • Kalamazoo、Michigan、美国、49009
        • Warner Chilcott Investigational Study Site
    • Minnesota
      • Chaska、Minnesota、美国、55318
        • Warner Chilcott Investigational Study Site
    • Nevada
      • Las Vegas、Nevada、美国、89113
        • Warner Chilcott Investigational Study Site
      • Las Vegas、Nevada、美国、89128
        • Warner Chilcott Investigational Study Site
    • New Jersey
      • Moorestown、New Jersey、美国、08057
        • Warner Chilcott Investigational Study Site
    • North Carolina
      • Greensboro、North Carolina、美国、27408
        • Warner Chilcott Investigational Study Site
      • New Bern、North Carolina、美国、28562
        • Warner Chilcott Investigational Study Site
      • Raleigh、North Carolina、美国、27607
        • Warner Chilcott Investigational Study Site
      • Winston-Salem、North Carolina、美国、27103
        • Warner Chilcott Investigational Study Site
    • Ohio
      • Cincinnati、Ohio、美国、45249
        • Warner Chilcott Investigational Study Site
      • Cleveland、Ohio、美国、44122
        • Warner Chilcott Investigational Study Site
      • Columbus、Ohio、美国、43213
        • Warner Chilcott Investigational Study Site
    • Pennsylvania
      • Jenkintown、Pennsylvania、美国、19046
        • Warner Chilcott Investigational Study Site
      • Philadelphia、Pennsylvania、美国、19114
        • Warner Chilcott Investigational Study Site
      • Pittsburgh、Pennsylvania、美国、15206
        • Warner Chilcott Investigational Study Site
    • Rhode Island
      • Warwick、Rhode Island、美国、02886
        • Warner Chilcott Investigational Study Site
    • South Carolina
      • Bluffton、South Carolina、美国、29910
        • Warner Chilcott Investigational Study Site
      • Greer、South Carolina、美国、29650
        • Warner Chilcott Investigational Study Site
    • Texas
      • Austin、Texas、美国、78759
        • Warner Chilcott Investigational Study Site
      • Dallas、Texas、美国、75230
        • Warner Chilcott Investigational Study Site
      • Dallas、Texas、美国、75231
        • Warner Chilcott Investigational Study Site
      • Dallas、Texas、美国、75234
        • Warner Chilcott Investigational Study Site
      • Houston、Texas、美国、77030
        • Warner Chilcott Investigational Study Site
      • San Antonio、Texas、美国、78229
        • Warner Chilcott Investigational Study Site
    • Utah
      • South Jordan、Utah、美国、84095
        • Warner Chilcott Investigational Study Site
    • Virginia
      • Norfolk、Virginia、美国、23507-1627
        • Warner Chilcott Investigational Study Site
      • Richmond、Virginia、美国、23233
        • Warner Chilcott Investigational Study Site
    • Washington
      • Seattle、Washington、美国、98105
        • Warner Chilcott Investigational Study Site
      • Spokane、Washington、美国、99207
        • Warner Chilcott Investigational Study Site

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

35年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Sexually active with self-identified dyspareunia (pain with sexual activity), at least moderate to severe and most bothersome symptom of vulvovaginal atrophy (VVA)
  • Postmenopausal and meets 1 of the following: 12 months spontaneous amenorrhea, 6 months spontaneous amenorrhea with FSH (follicle stimulating hormone) >40 mIU/mL,6 weeks postsurgical bilateral oophorectomy with confirmation by FSH >40 mIU/mL, surgical report or ultrasound, 6 weeks postsurgical hysterectomy with ovary failure confirmed by FSH >40 mIU/mL
  • Age ≥40 years; ≥35 with bilateral oophorectomy
  • Vaginal pH >5.0
  • Less than or equal to 5% superficial cells on vaginal wall cytologic smear
  • Normal clinical breast exam or negative mammogram if ≥ 40 years of age
  • Negative urine pregnancy test (non-hysterectomized and <12 months amenorrhea)

Exclusion Criteria:

  • Enrollment in Sponsor's Study PR-04409 or PR-05812
  • Participation in clinical trial or use of investigational drug within 30 days prior to screening
  • Known hypersensitivity to estrogen and/or progestin therapy
  • Known or suspected premalignant or malignant disease or history steroid-dependent malignancy
  • Manifestation or treatment for significant cardiovascular disease (congestive heart failure, stroke or ischemic attack, myocardial infarction, coronary artery bypass, percutaneous angioplasty or >50% angiographic narrowing of coronary artery
  • Thrombophlebitis or thromboembolic disorder or history of
  • Insulin-dependent diabetes mellitus
  • Increased frequency or severity of headaches while on hormone or estrogen therapy
  • Currently taking St. John's Wort
  • Drug/alcohol addiction within past 2 years
  • Treatment with anticoagulants (heparin or warfarin)
  • Smoking ≥15 cigarettes/day

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
有源比较器：Vehicle (3 Times/Week)
Vehicle applied to the vagina daily for 14 days followed by dosing 3 times per week for 10 weeks.
药品：Vehicle
Daily for 14 days followed by 3 times per week for 10 weeks
实验性的：WC3011 Estradiol Vaginal Cream (3 Times/Week)
WC3011 Estradiol vaginal cream applied daily for 14 days followed by dosing 3 times per week for 10 weeks.
药品：WC3011 Estradiol Vaginal Cream
Daily for 14 days followed by 3 times per week for 10 weeks
其他名称：
  • WC3011

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
阴道表层细胞百分比从基线到最终评估的变化
大体时间：基线（第 0 天）到最终评估（直到第 12 周）
从每个参与者收集阴道壁涂片。 涂片被送到中央实验室进行分析，以确定表层细胞的百分比。 基线的积极变化表示改进。 最终评估定义为最后一次可用的基线后评估。
基线（第 0 天）到最终评估（直到第 12 周）
阴道副基底层细胞百分比从基线到最终评估的变化
大体时间：基线（第 0 天）到最终评估（直到第 12 周）
从每个参与者收集阴道壁涂片。 涂片被送到中央实验室进行分析，以确定副基底层细胞的百分比。 基线的负变化表示改进。 最终评估定义为最后一次可用的基线后评估。
基线（第 0 天）到最终评估（直到第 12 周）
Change From Baseline in Participant's Self-Assessment of Symptom of Vulvovaginal Atrophy (VVA): Dyspareunia (Pain Associated With Sexual Activity) to Final Assessment
大体时间：Baseline (Day 0) to final assessment (Up to Week 12)
Participant's self-assessment of the symptom of VVA (dyspareunia) was scored on a 4-point scale where: 0=none, 1=mild, 2=moderate or 3=severe. Higher score indicates the most bothersome symptoms. A negative change from Baseline indicates improvement. Final Assessment is defined as the last available post-baseline assessment for the given efficacy endpoint.
Baseline (Day 0) to final assessment (Up to Week 12)
Change From Baseline in Vaginal pH to Final Assessment
大体时间：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 post-baseline assessment for the given efficacy endpoint.
Baseline (Day 0) to final assessment (Up to Week 12)

次要结果测量

结果测量
措施说明
大体时间
Change From Baseline in Participant's Self-Assessment of the Symptom of VVA: Dyspareunia to Weeks 2, 4, 8, and 12
大体时间：Baseline to Weeks 2, 4, 8 and 12
Participant's self-assessment of the symptom of VVA (dyspareunia) was scored on a 4-point scale where: 0=none, 1=mild, 2=moderate or 3=severe. Higher score indicates the most bothersome symptoms. A negative change from Baseline indicates improvement.
Baseline to Weeks 2, 4, 8 and 12
Change From Baseline in Participant's Self-Assessment of the Other Symptoms of VVA to Weeks 2, 4, 8, 12, and Final Assessment
大体时间：Baseline (Day 0) to Weeks 2, 4, 8, 12, and final assessment (Up to Week 12)
Self-Assessment of the symptoms of VVA, other than dyspareunia and vaginal bleeding associated with sexual activity, (vaginal and/or vulvar irritation/itching, dysuria and vaginal dryness) were evaluated by a questionnaire. Each symptom 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 post-baseline assessment for the given efficacy endpoint.
Baseline (Day 0) to Weeks 2, 4, 8, 12, and final assessment (Up to Week 12)
Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity at Each Visit
大体时间：Baseline (Day 0), Weeks 2, 4, 8, 12 and final assessment (Up to Week 12)
Vaginal bleeding associated with sexual activity was assessed by participants as either "present" or "absent". Number of participants with assessment "present" are reported. Final Assessment is defined as the last available post-baseline assessment for the given efficacy endpoint.
Baseline (Day 0), Weeks 2, 4, 8, 12 and final assessment (Up to Week 12)
Change From Baseline in the Investigator's Assessment of Each of the Signs of VVA to Week 12 and Final Assessment
大体时间：Baseline (Day 0) to Week 12 and Final assessment (Up to Week 12)
Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to the signs of VVA: atrophy, pallor, vaginal dryness, friability, and petechiae each graded on a 4-point scale where: 0=none, 1=mild, 2=moderate or 3=severe. Higher scores are worse. A negative change from Baseline indicates improvement. Final assessment is defined as the last available postbaseline assessment.
Baseline (Day 0) to Week 12 and Final assessment (Up to Week 12)
Change From Baseline in Vaginal pH to Week 12
大体时间：Baseline 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.
Baseline to Week 12
Change From Baseline in the Percentage of Vaginal Superficial Cells to Week 12
大体时间：Baseline 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.
Baseline to Week 12
Change From Baseline in the Percentage of Vaginal Parabasal Cells to Week 12
大体时间：Baseline 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.
Baseline to Week 12

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Warner Chilcott

调查人员

  • 研究主任：Anna Chan, PharmD、Warner Chilcott

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2013年4月12日

初级完成 (实际的)

2013年11月20日

研究完成 (实际的)

2013年11月20日

研究注册日期

首次提交

2013年4月25日

首先提交符合 QC 标准的

2013年4月29日

首次发布 (估计)

2013年5月3日

研究记录更新

最后更新发布 (实际的)

2022年5月9日

上次提交的符合 QC 标准的更新

2022年4月11日

最后验证

2021年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • PR-08112

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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