NCT00224094已完成4 期
A Comparison of Transdermal vs. Oral Estrogen Replacement Therapy on Androgen Levels and Thyroid Function in Naturally Menopausal Women
Watson Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2002年1月最近更新:
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
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Compare the effects of a 12-week course of oral CEE to a 12-week course of transdermal estradiol on free testosterone concentrations in menopausal women.
研究概览
简要总结
This study compares the effects of 12 weeks of treatment with transdermal versus oral estrogen therapy on testsoterone levels and thyroid tests in healthy, naturally menopausal women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 42 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Naturally menopausal women
- •Aged 42-70 years
- •Currently using combination estrogen-progestin replacement therapy
排除标准
- •Women with contraindications to HRT use, including:Unexplained vaginal bleeding, liver disease, breast or endometrial cancer, venous thromboembolic events
- •Thyroid disease
- •Adrenal disease
研究组 & 干预措施
Sequence A
Experimental
Oral ERT then transdermal ERT
干预措施: Premarin® (oral) vs. Alora® (transdermal) (Drug)
Sequence B
Experimental
Transdermal ERT then oral ERT
干预措施: Premarin® (oral) vs. Alora® (transdermal) (Drug)
结局指标
主要结局
Compare the effects of a 12-week course of oral CEE to a 12-week course of transdermal estradiol on free testosterone concentrations in menopausal women.
时间窗: 12 weeks
次要结局
- Compare the effects of oral versus transdermal ERT on thyroid binding globulin concentrations and tests of thyroid function.(12 weeks)
- Compare the effects of oral versus transdermal ERT on cortisol binding globulin and total and free cortisol concentrations.(12 weeks)
研究者
研究点 (1)
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