The Use of an MMP Inhibitor, Doxycycline, to Reduce Ovarian Androgen Production and Restore Normal Cycling in Women With Polycystic Ovarian Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Total Serum Testosterone
研究概览
简要总结
The purpose of this study is to study the effect of a commonly used antibiotic, doxycycline, on the production of ovarian hormones and menstrual cycles in women with Polycystic Ovarian Syndrome (PCOS).
详细描述
Polycystic ovarian syndrome (PCOS) is one of the leading causes of female infertility, affecting 5-10% of reproductive-age women . This heterogeneous disorder is characterized by anovulatory infertility, androgen excess, an increase in the ratio of LH to FSH, and morphologic polycystic changes to the ovaries. Obesity and insulin resistance are also metabolic factors associated with PCOS that further increase the morbidity in these patients. Inducing fertility in patients with PCOS can be a challenge, as it most often involves ovulation induction that can lead to ovarian enlargement, hyperstimulation, and multiple-birth pregnancies. This study is designed to determine novel effective strategies to promote normal cycling in this patient population.
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
- •Women between 18 and 40 years of age.
- •History of PCOS with < 8 periods the proceeding year
- •Clinical or biochemical evidence of androgen excess
- •Willingness to sign consent for study including participation with collection of blood specimens
- •Willingness to discontinue OCP for duration of study period up to 36 weeks
排除标准
- •Hypersensitivity to doxycycline or tetracycline
- •History of Cushing's syndrome
- •History of hyperprolactinemia
- •History of congenital adrenal hyperplasia
- •Significant hepatic impairment, including serum AST or ALT >1.5 times upper limits of normal.
- •Significant renal impairment, GFR <60 ml/min
- •Current use of metformin, statins, glucocorticoids, spironolactone and/or anti-estrogens.
研究组 & 干预措施
Doxycycline
Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.
干预措施: doxycycline (Drug)
Sugar Pill
The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control
干预措施: Sugar Pill (Other)
结局指标
主要结局
Total Serum Testosterone
时间窗: week 12
We will determine total serum testosterone levels in all participating subjects at week 12.
次要结局
- Total Number of Ovulations(week 24)
- Serum Hormone Binding Globulin (SHBG)(week 24)
- Serum Progesterone Levels in Blood(24 weeks)
- Free Testosterone in Serum(week 24)
研究者
Kathleen M. Hoeger, MD
Professor
University of Rochester