Effect of Short Term Ovarian Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess (CBS007)
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- 17 hydroxyprogesterone responses to rhCG before and 4 weeks after depot leuprolide administration
研究概览
简要总结
This study will test whether short-term suppression of ovarian function can ameliorate androgen (male hormone) overproduction in overweight girls with androgen excess. The investigators hypothesize that one dose of depot leuprolide agonist administration will improve androgen levels in girls with ovarian androgen overproduction. Specifically, this intervention will improve androgen levels after ovarian stimulation testing with recombinant human chorionic gonadotropin (rhCG).
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
- 7 Years 至 18 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •overweight (>85th BMI%) females
- •Early to late puberty (expected age range 7-18)
- •Hyperandrogenemic (free testosterone greater than 2.5 standard deviations above the mean for normal control subjects of the same Tanner Stage)
- •Screening labs within age-appropriate normal range, with the exception of a mildly low hematocrit (see below) and the hormonal abnormalities inherent in obesity which could include mildly elevated luteinizing hormone (LH), lipids, testosterone, prolactin, DHEAS, E2, glucose, and insulin and decreased follicle-stimulating hormone (FSH) and/or sex hormone-binding globulin (SHBG)
排除标准
- •Screening labs outside of age-appropriate normal range
- •Hemoglobin <12 mg/dL and hematocrit<36% (Subjects will be offered the opportunity to take iron supplementation for 60 days if their hematocrit is slightly low (33-36%) (suggestive of iron deficiency anemia) and will then return for retesting of their hemoglobin/hematocrit. If still <36%, they will be excluded.)
- •Morning Cortisol <5 g/dL
- •17-hydroxyprogesterone >295 ng/dL
- •History of Cushing's syndrome or adrenal insufficiency
研究组 & 干预措施
leuprolide
leuprolide 11.25 mg IM with adrenal suppression/stimulation testing with dexamethasone/Cortrosyn and ovarian stimulation testing with r-hCG before and 3 weeks after injection
干预措施: Leuprolide (Drug)
结局指标
主要结局
17 hydroxyprogesterone responses to rhCG before and 4 weeks after depot leuprolide administration
时间窗: 4 weeks after leuprolide
次要结局
- Ovarian hormone precursor responses to rhCG before and 4 weeks after depot leuprolide administration(4 weeks after leuprolide)
研究者
Christine Burt Solorzano
Assistant Professor of Pediatrics
University of Virginia