Investigation of Female Reproductive Hormone Dynamics During Adolescence
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Ovulation in Cycle 2
研究概览
简要总结
Irregular menstrual cycles are common in girls for several years after their first menstrual period. The cause of abnormal menstrual cycles during this time is not well-understood. The purpose of this study is to: 1) monitor girls during a menstrual cycle (with blood and urine sampling and serial pelvic ultrasounds) to identify those girls who do not ovulate (release of an egg from the ovary), and 2) determine whether cycles can be corrected by treating girls with a short course of low-dose estrogen and progesterone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 16 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •no more than 3 ½ years postmenarchal
排除标准
- •Subjects currently on or previously treated with medications that may affect reproductive hormones (eg birth control pills).
- •Subjects with severe acne or hirsutism
- •Subjects who exercise excessively (running > 20 miles/week or its equivalent)
- •Subjects with any of the following medical conditions: diabetes, hypertension, hyperlipidemia, valvular heart disease, lupus, rheumatoid arthritis, migraine headaches with aura, undiagnosed breast mass, inflammatory bowel disease, gallbladder disease, sickle cell disease, or thrombophilia.
- •Current smoker
- •History of deep venous thrombosis or pulmonary embolism in subject or first-degree relative
研究组 & 干预措施
Interventional
estradiol 50 mcg transdermal patch x 7 days oral micronized progesterone 0.5 mg/kg/dose TID x 7 days
干预措施: micronized progesterone (Drug)
Interventional
estradiol 50 mcg transdermal patch x 7 days oral micronized progesterone 0.5 mg/kg/dose TID x 7 days
干预措施: transdermal estradiol (Drug)
结局指标
主要结局
Ovulation in Cycle 2
时间窗: 20-40 days
serum progesterone \> 3 ng/ml or presence of corpus luteum on pelvic ultrasound
次要结局
未报告次要终点
研究者
Janet E. Hall, MD
Professor of Medicine
Massachusetts General Hospital