Inducing a Medical Castration With a GnRH Agonist While Simultaneously Replacing Physiologic Levels and Patterns of Human Sex Steroid Hormones Using an Ethylvinyl Acetate (EVA) Vaginal Ring Delivery System
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Serum Leuprolide Levels After EVA Ring Transvaginal Drug Delivery System Insertion
研究概览
简要总结
This research study is looking at how well a new drug delivery system, called the vaginal ring, works to get hormones into your body as a form of birth control.
详细描述
3-Day Study (outpatient)
Healthy normal volunteers will participate in a 3-day outpatient study that will begin between days 1-7 of their menstrual cycle (i.e. early follicular phase). A negative urinary hCG will be obtained in these women prior to their starting the 3-day study. On the first day, subjects will have 4 baseline blood samples of 5mL each drawn at 20-minute intervals over an hour (Time = 0, +20, +40, +60). These will be pooled and will represent the pretreatment determination of gonadotropins and sex steroid levels. Thereafter, the individual vaginal rings to be tested will be inserted. Over the ensuing 3 days, subjects will have 3 blood draws per day (at approximately 8-9 AM, 12-1PM, and 4-5PM).
Serum levels of LH, FSH, E2, and P will be determined at the above time points for the next 3 days. A repeat CBC and LFT's will be done with the final blood draw. The only exceptions to this protocol will be those patients with the Sex Steroid Only rings in whom 75 ug/kg of a GnRH antagonist (Acyline IND# 58,448) will be administered subcutaneously every other day and upon subsequent onset of menses, subjects will return during day 3-6 for repeat LFT's and gonadotropins. This will ensure the return of normal liver function and hormonal levels.
A visual vaginal examination and colposcopy will be done at baseline and at the time of the removal of the ring. If lesions or abrasions are found at study termination, subjects will be followed until the lesions resolve. For the initial 3-day studies, daily visual inspection of the vaginal tissues will be conducted and findings recorded in a standardized manner.
The schedule of more intensive early sampling is selected to be certain that no rapid release of medication occurs from the rings during the earliest phase following their insertion. This will also document that we have, in fact, achieved a steady state of release of the ring's content in the circulation prior to expanding the duration of these studies to 14 days in the second portion of part A.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •A history of normal regular menstrual cycles (25-35 days);
- •A normal physical examination;
- •A body mass index (BMI) between 19 & 29
- •A normal CBC, normal Prolactin level, normal LFT's
- •A negative urinary hCG at the initiation of each study; and
- •An agreement to refrain from attempting to conceive during the experimental cycle and the cycle thereafter by either abstinence and/or use of a barrier method of contraception.
排除标准
- 未提供
研究组 & 干预措施
A
干预措施: Ethylvinyl Acetate (EVA) Vaginal Ring Delivery System (Drug)
结局指标
主要结局
Serum Leuprolide Levels After EVA Ring Transvaginal Drug Delivery System Insertion
时间窗: 8 hours
次要结局
未报告次要终点
研究者
Alexandra Kimball
Principal Investigator
Massachusetts General Hospital
