Clinical Guidance to Increase Women's Awareness of Some Contributing Factors to Help Proper Treatment of Unexplained Resistant Hyperprolactinemia Not Responding to Therapeutic Dopamine Agonists (DA)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Achievement of normoprolactinemia after one month of therapy of hyperprolactinemia
研究概览
简要总结
Many women despite being well-treated in proper dose, with proper drug and for proper duration, may not respond to different forms of prolactin normalizing drugs.
This will lead to extension of the treatment duration up to months or even years.
Doctors usually increase the dose of the drug with high possibility of side effects and even complications. Some doctors change drug group to another without any significant improvement of hyperprolactinemia. hyperprolactinemia can indicate a deeper issue, about 10 percent of the population has hyperprolactinemia. Life style, feeding habits and sexual behaviors are usually not included in the management protocols of hyperprolactinemia.
Aim of the study:
This study will be aimed to:
test the impact of clinical guidance to increase women's awareness of some contributing factors to help proper treatment of unexplained resistant hyperprolactinemia not responding to therapeutic DA (cabergoline 1.5-2 mg/week).
Hypothesis of the study:
H1- Health education for women under drugs of hyperprolactinemia is effective to reduce the level of prolactin.
H0- Health education for women under drugs of hyperprolactinemia is not effective in reducing the level of prolactin
详细描述
Subjects and methods:
All women diagnosed to have hyperprolactinemia as diagnosed by one laboratory (lab of the Woman's Health University Hospital).
Research Design:
Prospective study (randomized controlled trial) .
Setting:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
盲法说明
Hyperprolactinemic women receiving cabergoline therapy will be divided into 2 groups: with health education and without health education.
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group A
Women with hyperprolactinemia are scheduled for cabergoline therapy cabergoline 1.5-2 mg/week. for one month plus health education.
干预措施: cabergoline 1.5-2 mg/week).orally daily for 1 month plus health education (Drug)
Group B
Women with hyperprolactinemia are scheduled for cabergoline therapy 1.5-2 mg/week. for one month without health education.
干预措施: cabergoline 1.5-2 mg/week).orally daily for 1 month without health education (Drug)
结局指标
主要结局
Achievement of normoprolactinemia after one month of therapy of hyperprolactinemia
时间窗: 1 month
response of hyperprolactinemic women to carbergoline o.5 mg for one month with or without health education by a nurse to achieve normoprolactinemia.
次要结局
未报告次要终点
研究者
Professor Atef Darwish
Professor of Obstetrics and Gynecology
Woman's Health University Hospital, Egypt