跳至主要内容
临床试验/NCT05263102
NCT05263102已完成不适用

Evaluation of the Efficacy and Safety of A High Molecular Weight, Natural Hyaluronic Acid Vaginal Gel in Women With Genitourinary Syndrome of Menopause

HAN Biomedical Inc5 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
5
主要终点
pH value change

研究概览

简要总结

The aim of the study is to evaluate the safety and efficacy of the vaginal gel with HMW HA in women with genitourinary syndromes due to either menopause or other causes such as the patients after ovarian or breast cancer diagnosis and treatment.

详细描述

It was recognized that GSM is likely to be underdiagnosed and undertreated9. The North American Menopause Society (NAMS) issued the treatment guideline of GSM in 2014 and encouraged the physicians and nurses to pursue menopausal women to check if they have genitourinary syndrome. GSM is considered a progressive condition in menopausal women, and the primary goal of treatment strategy is symptom relief. Options include lifestyle changes, non-hormonal, and hormonal treatments. Hormonal therapies include both topical and systemic approaches. However, many women reported that substantial concerns about the long-term safety of hormonal products.The patients are aware of the possible relationship between cancer, heart disease, stroke, and estrogen-based treatments10. For considering long-term treatment strategy, estrogen free products of vaginal lubricant or vaginal moisturizer are recommended as first line treatment for those with mild to moderate syndrome.

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

性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Subjects have been diagnosed with cervical or vaginal malignant neoplasms
  • Subjects with abnormal undiagnostic genital bleeding
  • Subject with active vaginal infection
  • Subjects with vaginal pH value < 4.5
  • Subjects are under hormone replacement therapy within three months
  • Subjects are under phytoestrogen treatment within two month
  • Subjects use of vaginal douche, lubricant or moisturizer in one week
  • Subjects are hypersensitive to sodium hyaluronate, carrageenan

结局指标

主要结局

pH value change

时间窗: from baseline to week 8

The change of the vaginal pH value

次要结局

  • Vaginal maturation index (VMI)(from baseline to week 8)
  • The Questionnaire of Genitourinary Syndromes of Menopause(from baseline to week 8)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (5)

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