ACTRN12609000154202终止4 期
A randomised, open-label, comparative, mult-centre trial to test the efficacy and systemic absorption of vaginal estradiol or estriol compared with a non-hormonal preparation in postmenopausal breast cancer patients with symptomatic atrophic vaginitis using the aromatase inhibitor, anastrozole
School of Women's and Infants' Health0 个研究点目标入组 84 人开始时间: 2009年3月18日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 84
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- o limit 至 o limit（—）
- 性别
- Female
入选标准
- •History of oestrogen receptor positive breast cancer.
- •Post menopausal.
- •Taking anastrozole 1 mg orally once a day for at least 6 weeks.
- •Symptoms of atrophic vaginitis (vaginal dryness, discomfort, pruritis, dyspareunia, urinary tract infections and urinary urgency) and requesting treatment for these.
- •Willing to be randomised.
- •Scoring at least 0 or 1 on the Eastern Cooperative Oncology Group Performance Scale.
排除标准
- •History of advanced breast cancer
- •Taking systemic oestrogens, tamoxifin or tibolone in previous 6 weeks
- •Current vaginal infection
- •Postmenopausal bleeding
- •History of endometrial hyperplasia or endometrial cancer
- •Using other vulval or vaginal preparations
- •Abnormal cervical smear, carcinoma in situ, invasive carcinoma at screening
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