Phase 2 Study of Recombinant Human Prolactin Efficacy and Safety
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Galactorrhea
研究概览
简要总结
Medications used to increase breast milk production increase prolactin secretion, the main hormone of lactation. There are no FDA approved medications used to improve breast feeding, but metoclopramide is used off-label and can have intolerable side effects. We examined the biological activity and safety of recombinant human prolactin (r-hPRL) as a potential medication to augment lactation. In this study, the effect of r-hPRL on breast milk production in women who did not recently deliver a baby and its effect on the bones and menstrual cycle were tested.
详细描述
There are no FDA approved medications in the U.S. to augment lactation. Metoclopramide is used off-label but can have intolerable side effects. We examined the biological activity and safety of recombinant human prolactin (r-hPRL) as preliminary data for its use to augment lactation. Healthy, non-postpartum women (n=21) with regular menstrual cycles underwent a 7 day randomized, double-blind, placebo-controlled trial of r-hPRL. Galactorrhea, markers of bone turnover, calcium homeostasis and gonadal function were measured and side effects recorded.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Healthy Subjects will meet the following criteria:
- •18 to 40 years of age
- •Normal weight (BMI 17 to £ 30 kg/m2)
- •Good general health
- •On no medications for at least 3 months before the study
- •Regular menstrual cycles every 25-35 days with ovulation documented by a luteal phase progesterone level
- •No evidence of androgen excess
- •Normal TSH, prolactin and hematocrit
- •No current interest in conception
- •No history of osteoporosis
- •No use of medications known to affect bone turnover
- •No alcoholism
- •No history of medical problems or treatment known to affect bone turnover.
排除标准
- •Subjects will be excluded for pregnancy or evidence of breast masses.
研究组 & 干预措施
recombinant human prolactin
Recombinant Human Prolactin 60 mcg/kg once daily subcutaneous injection
干预措施: Recombinant Human Prolactin (Drug)
Placebo
Normal saline placebo subcutaneous injection
干预措施: Recombinant Human Prolactin (Drug)
结局指标
主要结局
Galactorrhea
时间窗: 7 days
Galactorrhea is breast milk production.
次要结局
- Menstrual Cycle Length(28 days)
- N-telopeptide(7 days)
- Estradiol(7 days)
研究者
Corrine Welt
Associate Professor of Medicine
Massachusetts General Hospital