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临床试验/TCTR20220510004
TCTR20220510004已完成1 期

Effectiveness of 12.5 microgram versus 25 microgram 17beta-estradiol estrogen vaginal gel in postmenopausal vaginal atrophy women: A 3-month randomized non-inferior trial

Siriraj Hospital, Mahidol University0 个研究点目标入组 80 人开始时间: 2022年5月10日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
80

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
45 Years 至 80 Years(—)
性别
Female

入选标准

  • 1.Postmenopausal women aged 45 years older
  • 2.Who were amenorrhea for 12 months or who had undergone bilateral oophorectomy since 6 weeks or more
  • 3.Vaginal symptoms related to postmenopausal status (vaginal dryness, vaginal or vulvar irritation, vaginal soreness, vaginal discharge, and/or dyspareunia).
  • 4.Endometrial thickness no more than 5 mm as measured by transvaginal ultrasonography among women with uterus
  • 5.Normal cervical cytology within 3 years
  • 6.Informed consent

排除标准

  • 1.Known or suspected history of breast cancer
  • 2.Abnormal uterine bleeding with unknown cause
  • 3.Thromboembolism
  • 4.Hypersensitivity to the study medication or ingredient
  • 5.Previous hormone use within 90 days
  • 6.Genital tract infection
  • 7.Cardiovascular disease
  • 8.Liver disease or gallbladder disease
  • 9.Denied to participate in this study

研究者

发起方
Siriraj Hospital, Mahidol University

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