NCT00745108已完成3 期
A Multinational, Multicenter, Randomized, Double-blind, Parallel Group, Active Controlled, Comparative Trial, to Assess the Endometrial Histological Profile Following Treatment With Tibolone (Org OD14) Versus Conjugated Estrogen (CE) Plus Medroxyprogesterone Acetate (MPA) in Postmenopausal Women
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- Endometrial biopsy and histological examination
研究概览
简要总结
Tibolone has been registered for the treatment of climacteric symptoms and for the prevention of postmenopausal osteoporosis. This is a 2-year study to further confirm the endometrial safety of tibolone in comparison with CE/MPA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 是
入选标准
- •Healthy postmenopausal women, 45 to 65 years of age with an intact uterus. Women must have been postmenopausal for less than 15 years, have an atrophic or inactive endometrium, and a body mass index of 18 - 32 kg/ m2 (inclusive).
排除标准
- •Final diagnosis of the endometrial biopsy as 'no tissue' or 'tissue insufficient for diagnosis'.
- •Double layer endometrial thickness > 6 mm as assessed by transvaginal ultrasonography (TVUS).
- •Any previous or current unopposed estrogen administration or tamoxifen citrate.
- •Any unexplained vaginal bleeding following the menopause.
- •Women with abnormal Pap smear test results (PAP IIb and higher)
- •Previous use of raloxifene hydrochloride for longer than one month.
研究组 & 干预措施
Tibolone 1.25 mg
Experimental
干预措施: tibolone (Drug)
Tibolone 2.5 mg
Experimental
干预措施: Tibolone 2.5 mg (Drug)
CE/MPA
Active Comparator
干预措施: CE/MPA (Drug)
结局指标
主要结局
Endometrial biopsy and histological examination
时间窗: At 1 year and 2 year.
次要结局
- Double-layer endometrial thickness by transvaginal ultrasonography (TVUS), vaginal bleeding from a Bleeding Episode Log.(TVUS: at 1 year and 2 year; Vaginal bleeding: daily recording)
研究者
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