跳至主要内容
临床试验/NCT02014428
NCT02014428已完成4 期

Oral Low-molecular Weight Hyaluronic Acid in the Treatment of Atrophic Vaginitis

AGUNCO Obstetrics and Gynecology Centre1 个研究点 分布在 1 个国家开始时间: 2013年12月18日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
试验地点
1
主要终点
Atrophic vaginal changes

研究概览

简要总结

To evaluate the effectiveness of low molecular weight hyaluronic acid oral tablets for the treatment of atrophic vaginitis.

研究设计

研究类型
Interventional

入排标准

年龄范围
45 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • at least 12 months postmenopausal
  • mucosal atrophy and the main bothersome related symptoms, such as itching, burning, and dyspareunia.

排除标准

  • 未提供

研究组 & 干预措施

Hyaluronic acid

Experimental

220 mg hyaluronic acid per tablet (two tablets/day for 10 days, and subsequently one tablet/day for three months)

干预措施: Hyaluronic acid (Dietary Supplement)

Placebo

Placebo Comparator

two tablets/day for 10 days, and subsequently one tablet/day for three months

干预措施: Placebo (Drug)

结局指标

主要结局

Atrophic vaginal changes

时间窗: Change from baseline epithelium at 3 months

Morphometric analysis of biopsies.

次要结局

  • Assessment of Dyspareunia(Change from baseline Dyspareunia at 3 months)
  • Assessment of Itching(Change from baseline Itching at 3 months)
  • Assessment of Burning(Change from baseline Burning at 3 months)

研究者

发起方
AGUNCO Obstetrics and Gynecology Centre
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验