Pilot of Letrozole for Uterine Myomas
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Changes in Fibroid-related Symptoms After Treatment With Letrozole
研究概览
简要总结
PLUM evaluates the drug letrozole as a treatment for uterine fibroids. This study is a randomized, blinded, placebo-controlled trial of oral letrozole among premenopausal women with symptomatic uterine fibroids. Participants will be randomly assigned in a 1:1 ratio to either oral letrozole 2.5mg/day for 6 months (Group A) or intermittent dosing with letrozole 2.5mg/day and an identical placebo capsule (Group B).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •≥21 years old
- •Premenopausal (at least one menses in last 3 months)
- •Symptomatic fibroids (fibroids visualized on ultrasound or MRI and heavy uterine bleeding, pelvic pressure or discomfort, urinary or bowel abnormalities, dyspareunia)
- •Fibroids that are ≤4 in total number or Fibroids that are ≤7 in total number if all fibroids are less than 4cm (40 mm) each
- •Fibroids that are ≤7cm in maximum diameter, on screening imaging, if ≤4 fibroids in total number(fibroid is defined as any mass with radiographic characteristics of fibroid >2cm)
- •Up to date in Pap smear screening and surveillance
- •Endometrial biopsy (required if age>45 years with irregular bleeding) does not indicate premalignant or malignant cells
- •Agree to use non-hormonal barrier method of contraception during study period if at risk for pregnancy
- •Has primary care provider or gynecologist
- •Agrees not to start new medications/treatments for fibroids during the study
- •Able to give informed consent
排除标准
- •Fibroids treated by surgery, radiologic procedure, or GnRH agonist or antagonist in the last 3 months
- •Any submucosal fibroid ≥2cm that is >50% in uterine cavity (FIGO Type 0 or Type 1 fibroids) amenable to hysteroscopic resection
- •Use of exogenous estrogen and/or progestin in the last month. (for 3 month long-acting depoprovera injection, no use in last 3 months)
- •Pregnant, lactating, or planning to become pregnant in the next 6 months
- •Hematocrit <27% or visit to emergency room or hospitalization for fibroid symptoms in the last 3 months (cannot be safely randomized to a placebo)
- •History of osteopenia or osteoporosis
- •History of hyperlipidemia
- •Current liver or kidney disease
- •Unable or unwilling to attend 4 study visits
- •Pelvic imaging concerning for gynecologic cancer or cancer of the genitourinary or gastrointestinal system
- •Does not have primary care provider or gynecologist
研究组 & 干预措施
Letrozole
Oral letrozole 2.5mg/day
干预措施: Letrozole (Drug)
Placebo and Letrozole
Intermittent oral letrozole 2.5mg/day for 2 months and an identical placebo capsule for 4 months
干预措施: Letrozole (Drug)
Placebo and Letrozole
Intermittent oral letrozole 2.5mg/day for 2 months and an identical placebo capsule for 4 months
干预措施: Placebo (Other)
结局指标
主要结局
Changes in Fibroid-related Symptoms After Treatment With Letrozole
时间窗: Baseline to 2 Months
The Uterine Fibroid Sympton and Quality of Life (UFS-QoL) Symptom Severity score measures self-reported severity of fibroid-related symptoms. Symptoms include: fatigue, sleep, self-image, mood disturbances/psychologic distress, fear of embarrassment, interference with daily activities, relationships with family and friends, and sexual functioning. Scores range from 0 to 100; higher scores indicate greater symptom severity.
次要结局
未报告次要终点