Assessment of Sensitivity of the Hypothalamic GnRH Pulse Generator to Estradiol and Progesterone Inhibition in Early Pubertal Girls (JCM026)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- LH Pulse Frequency as a Function of Day 7 Progesterone
研究概览
简要总结
Gonadotropin-releasing hormone (GnRH) is a hormone that regulates the ability of the pituitary to secrete two hormones, luteinizing hormone (LH) and follicle-stimulating hormone (FSH). LH and FSH control the production of female hormones (such as estrogen and progesterone) and the development of eggs by the ovary. Progesterone and estrogen then decrease the number of GnRH pulses produced by the brain (and therefore the number of LH pulses from the pituitary). The ability to decrease GnRH pulses seems to be very important for normal menstrual function in adult women. The purpose of this study is to learn more about how GnRH and LH pulses are controlled during puberty. The information gathered in this study will hopefully allow us to learn more about how menstrual cycles are normally established in girls during puberty.
详细描述
In this study, the investigators will aim to discover the effect of 7 days of estrogen and progesterone on GnRH pulses in girls in early and mid puberty. Ultimately, if the investigators understand these normal processes, the investigators may be able to better understand abnormalities of puberty.
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
- 8 Years 至 14 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Girls ages 8 to 14
- •Tanner 1-3 pubertal stage
- •Pre-menarchal
- •Normal screening labs
排除标准
- •Abnormal screening labs
- •Congenital adrenal hyperplasia
- •Hyperandrogenism (e.g., hirsutism, elevated free testosterone level)
- •Hemoglobin <12 mg/dL or 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.)
- •Weight < 31 kg
- •History of peanut allergy, deep venous thrombosis, breast cancer, endometrial cancer, or cervical cancer
- •On hormonal medications (including oral contraceptive pills) or on medications known to affect the reproductive axis within 3 months of the study
- •Pregnant or breast feeding
- •Participation in a research study within the past 30 days that involved taking a study drug.
- •Participation in a research study that involved taking up to or greater than 473 ml's of blood within the past 60 days.
- •Cigarette smoking
- •History of surgery that required bedrest within the past 30 days
- •Family history of hypercoagulability or unexplained thromboembolic disease (not in setting of bedrest, surgery, or malignancy)
- •In order to ensure an adequate number of younger girls, no more than 4 enrolled subjects will be Tanner stage 3
研究组 & 干预措施
Progesterone, estrace
oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr to achieve mean plasma concentrations over the range of 2-8 ng/ml for seven days
oral estrace, 0.5-1 mg once a day for seven days
干预措施: Progesterone (Drug)
Progesterone, estrace
oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr to achieve mean plasma concentrations over the range of 2-8 ng/ml for seven days
oral estrace, 0.5-1 mg once a day for seven days
干预措施: Estrace (estrogen) (Drug)
结局指标
主要结局
LH Pulse Frequency as a Function of Day 7 Progesterone
时间窗: 7 days following oral estrace and progesterone administration
number of LH pulses per 11 hours on Day 7 of progesterone
次要结局
未报告次要终点
研究者
John Marshall
Director, Center for Research in Reproduction
University of Virginia