Comparison of Transdermal and Oral Estrogens in Adolescents With Ovarian Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Estradiol
研究概览
简要总结
To directly compare the safety (by laboratory evaluation) and efficacy (feminization and growth) of three commonly used estrogen preparations in adolescent patients with ovarian failure, either due to congenital causes (Turner syndrome) or medical therapies. We hypothesize that transdermal estrogen will have equivalent efficacy and a more favorable safety profile in comparison with conventional oral estrogen replacement.
详细描述
Treatment with transdermal 17beta(17β) estradiol resulted in higher estradiol levels and more effective feminization compared to oral conjugated equine estrogen but did not result in an otherwise different biochemical profile in this limited number of heterogeneous patients. OBE (oral beta estradiol) and TBE (transdermal beta estradiol) provide safe and effective alternatives to OCEE (oral conjugated equine estrogen) to induce puberty in girls, but larger prospective randomized trials are required.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •in whom initiation of estrogen therapy has been recommended due to ovarian failure
- •Outpatients
- •age >=12 years to 17.99 years old
排除标准
- •spontaneous menses
- •significant concurrent medical problem including:
- •Liver function tests (LFTs) 3 times normal
- •clotting disorder
- •ongoing cancer treatment
研究组 & 干预措施
Vivelle-Dot
17Beta Estradiol - transdermal
干预措施: 17Beta Estradiol - transdermal (Drug)
Vivelle-Dot
17Beta Estradiol - transdermal
干预措施: Progesterone, micronized (Drug)
Premarin
Conjugated estrogens
干预措施: Conjugated estrogens (Drug)
Premarin
Conjugated estrogens
干预措施: Progesterone, micronized (Drug)
Estrace
17beta Estradiol
干预措施: 17beta Estradiol (Drug)
Estrace
17beta Estradiol
干预措施: Progesterone, micronized (Drug)
结局指标
主要结局
Estradiol
时间窗: end of study (up to 2 years)
Estradiol blood levels at end of study compared across groups to determine effect of dosing methods. Significance of levels depends on the stage of puberty and goals of therapy.
次要结局
未报告次要终点
研究者
Darrell M Wilson
Principle Investigator
Stanford University