Aromatase Inhibitors for the Prevention of the Growth of Uterine Leiomyomas in Perimenopausal Women: A Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The primary end point of this study will be the baseline to end point percent difference in leiomyoma volume at 2 months and 6 months following treatment with Letrozole.
研究概览
简要总结
Fibroids are benign tumors that might results in bleeding. Surgery is their definitive treatment. Some medical therapies have been tried for women who wish to preserve their uterus. Recent reports have demonstrated a role for a new category of drugs called aromatase inhibitor (such as Femara) in the treatment of fibroids. This study is conducted to assess the effect of Femara (letrozole) on the size of fibroids in women around menopause.
详细描述
Fibroids (leiomyomas) are benign tumors that originate in the musculature of the uterus. They are the most common cause for removal of the uterus in women. Surgery is the final definitive treatment of fibroids. However, surgery is relatively risky. Hence, a few medical therapies have been tried for women who wish to preserve their uterus. However, most of those therapies have side effects that prohibit their routine use. Recent reports have demonstrated a role for a new category of drugs called aromatase inhibitor ( such as Femara) in the treatment of fibroids. To the best of our knowledge, this drug has not been studied yet in the management of fibroid of the uterus apart from one case report.
The objective of the current study is to assess the effect of aromatase inhibitors, specifically Femara (letrozole) on the size of fibroids in women around menopause. We are hoping that by decreasing their size, we could avoid having patients undergo surgery. The data generated is invaluable in that sense.
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
- 50 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Perimenopausal women (≥ 50 years) with symptomatic uterine leiomyomas (menometrorrhagia, pressure symptoms, urinary retention, pelvic pain) or those with large leiomyomas ≥ 7 cms
排除标准
- •Women <50 years of age
- •Postmenopausal women
- •Women with impaired renal function
- •Oral treatment with any type of estrogen or progesterone more recently than 1 month
- •History of venous thromboembolism
- •Any contraindication for Magnetic Resonance Imaging (MRI)
研究组 & 干预措施
aromatase inhibitors: Letrozole
All consenting patients will be started on Letrozole at a dose of 2.5 mg/day for 8 weeks.
干预措施: Letrozole (aromatase inhibitor) (Drug)
结局指标
主要结局
The primary end point of this study will be the baseline to end point percent difference in leiomyoma volume at 2 months and 6 months following treatment with Letrozole.
时间窗: 2 months and 6 months following treatment
次要结局
- Improvement in symptoms(2 and 6 months following treatment)
- Need for a surgical intervention(2 and 6 months following treatment)
- Improvement in the hemoglobin levels(2 and 6 months following treatment)
- Development of side effects: hot flushes, nausea,vomiting, headache, thrombophlebitis(2 and 6 months following treatment)