NCT07042581招募中4 期
Evaluation of Revaree Plus in Women With Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 14
- 主要终点
- Change in Vaginal Assessment Scale from baseline to 8 weeks
研究概览
简要总结
The purpose of this study is to find out whether Revaree Plus is effective at improving vaginal health for people who are having symptoms of vaginal dryness during breast cancer treatment.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age at the time of signing informed consent.
- •Stage 0-3 hormone-receptor positive breast cancer confirmed at MSKCC
- •Able to complete study questionnaires in English or Spanish
- •Breast cancer patients must have completed primary therapy (surgery, and/or chemotherapy, and/or radiation therapy) or currently on maintenance therapy
- •Currently on an aromatase inhibitor or tamoxifen or Selective Estrogen Receptor Modulators (SERM)
- •Currently have no clinical evidence of disease
- •Reporting being bothered by vaginal symptoms of estrogen deprivation (i.e., vaginal dryness, dyspareunia, or discomfort [pain with intercourse or examination])
- •A total score of 4 or greater in VAS
- •Without history of other cancers (excluding non-melanoma skin cancer)
- •Must sign an informed consent indicating that the participant understands the purpose of, and procedures required for the study and is willing to participate in the study
排除标准
- •Inability to provide informed consent
- •Vaginal bleeding of unknown etiology within 12 months of study entry
- •Currently taking hormone replacement therapy [local or systemic] (Patients must discontinue for 4 weeks in order to be eligible prior to study enrollment)
- •Existing use of external estrogens or nonhormonal moisturizers (Patients must discontinue for 4 weeks in order to be eligible prior to study enrollment)
- •No known allergies to any ingredients in 10mg HLA suppository
研究组 & 干预措施
Hormone-receptor positive breast cancer participants
Experimental
Participants will have a diagnosis of Stage 0-III Hormone-receptor positive breast cancer
干预措施: Revaree Plus (Drug)
结局指标
主要结局
Change in Vaginal Assessment Scale from baseline to 8 weeks
时间窗: 8 weeks
The primary study objective is to evaluate whether vaginal health improves from baseline to 8 weeks of treatment with Revaree Plus as measured by the Vaginal Assessment Scale
次要结局
未报告次要终点
研究者
研究点 (14)
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