NCT00117260撤回3 期
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a 91-Day Extended-Cycle Combination Oral Contraceptive (Seasonale) for the Treatment of Low Bone Mineral Density in Adolescent Females With Secondary Amenorrhea and Osteopenia
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Mean percent change in the lumbar spine bone mineral density at month 12
研究概览
简要总结
This is a randomized, multicenter, placebo-controlled study to evaluate the effects of Seasonale, an extended-regimen oral contraceptive, on bone mineral density in adolescent females who have had their menstrual period but now have secondary amenorrhea and also have osteopenia. The duration of the study for each patient will be approximately two years.
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
- Double
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Not sexually active and agree to remain sexually inactive throughout the course of the study
- •First menstrual period at least one year ago
- •No menstrual period in the last 6 months
排除标准
- •Undiagnosed abnormal genital bleeding
- •Known or suspected pregnancy
- •Medical history of any disorder that contraindicates the use of oral contraceptives
结局指标
主要结局
Mean percent change in the lumbar spine bone mineral density at month 12
次要结局
- Change in body weight
- Mean percent change in total body bone mineral density
- Mean change in biochemical markers of bone resorption and bone formation
- Mean percent change in the proximal femur (hip) bone mineral density
- Interim and 24 month mean percent change in lumbar spine bone mineral density
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