Impact of Vaginal Administration of Metformin in Women With PCOS.
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Ovulation rates
研究概览
简要总结
Polycystic ovary syndrome is a common cause of irregular periods, poor ovulation and delay in achieving pregnancy. Certain drugs may help improve ovarian activity in such women as metformin. Oral administration of metformin is accompanied by undesirable side effects. The vagina proved to be a good alternative to the oral route for other drugs. Using metformin through the vagina and avoidance of such side effects, while maintaining its effectiveness, would help women to better tolerate this drug.
详细描述
PCOS is the most common of all female endocrinopathies affecting 7-10% of women. A variety of drugs have been used to help improve follicular dynamics in PCOS patients. Metformin, an insulin sensitizer long known for its antidiabetic properties, has been used in PCOS patients. One of the major factors affecting compliance are the gastrointestinal side effects associated with oral administration of metformin. Knowing that the vagina is a good absorptive surface for many drugs, it is postulated that vaginal administration of metformin could be a good alternative to the oral route, if it proves effective. Both pharmacokinetic and clinical evidences of efficacy are traced for the vaginal route of administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women with PCOS according to the Rotterdam criteria
- •age 20-35 years
- •not to have received any induction of ovulation in the preceding 3 months before enrollment
排除标准
- •contraindications to metformin
- •prior surgical management of PCOS
研究组 & 干预措施
Oral metformin
Metformin 850 mg tablets taken by mouth every 12 hours for 6 months
干预措施: Metformin (Drug)
Vaginal metformin
Metformin 850 mg tablets taken vaginally every 12 hours for 6 months
干预措施: Metformin (Drug)
结局指标
主要结局
Ovulation rates
时间窗: 6 months
Ovulation rates assessed by transvaginal sonography (TVS) after oral versus vaginal administration of metformin in PCOS women.
次要结局
- Therapeutic drug level(Over 24 hours after administration.)