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来曲唑治疗子宫肌瘤处方 (PLUM)

2026年10月5日 更新者：University of California, San Francisco

来曲唑治疗子宫肌瘤：一项随机、安慰剂对照试验

The PLUM Study is a randomized, double-blinded, 2-arm, parallel-group, placebo-controlled trial is designed to compare the efficacy of letrozole versus placebo on leiomyoma-related symptoms and quality of life as well as leiomyoma and uterine size.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

140

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 美国
    • California
      • Los Angeles、California、美国、90095
        • 招聘中
        • University of California, Los Angeles
        • 接触：
        • 首席研究员：
          • Ram Parvataneni, MD
        • 首席研究员：
          • Jacqueline Fahey, MD
      • San Francisco、California、美国、94115
        • 招聘中
        • University of California, San Francisco
        • 首席研究员：
          • Vanessa L Jacoby, MD, MAS
        • 首席研究员：
          • Alison Huang, MD, MAS
        • 接触：
        • 接触：
    • Minnesota
      • Rochester、Minnesota、美国、55905
        • 招聘中
        • Mayo Clinic
        • 接触：
        • 首席研究员：
          • Sarah Rassier, MD
    • Mississippi
      • Jackson、Mississippi、美国、39216
        • 招聘中
        • University of Mississippi Medical Center
        • 接触：
          • Sheila Belk
        • 首席研究员：
          • Kedra Wallace, PhD
        • 副研究员：
          • Elizabeth Lutz, MD
        • 接触：
    • North Carolina
      • Durham、North Carolina、美国、27710
        • 招聘中
        • Duke University
        • 首席研究员：
          • Craig Sobolewski, MD
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

21年 至 53年 (成人)

接受健康志愿者

是的

有资格学习的性别

女性

描述

Inclusion Criteria:

  • At least 21 and less than 54 years of age (to focus on an adult, premenopausal population)
  • Female sex, based on sex identified on their birth certificate (no other gender requirements)
  • Have uterine leiomyomata that have been visualized on pelvic imaging (i.e., ultrasound or MRI) in the last 24 months
  • Report symptoms associated with leiomyomata such as heavy uterine bleeding, pelvic pressure or discomfort, urinary or bowel abnormalities, or dyspareunia for the past 3 months
  • Have at least moderate leiomyomata symptom burden, with UFS-QOL SSS score of 30 or higher at baseline
  • Has had a menstrual period in the past 3 months (90 days)
  • Agree to use a non-hormonal or barrier method of contraception with any sexual activity with a non-sterile male partner during the study period (i.e., use of copper IUD is consistent with eligibility)

Exclusion Criteria:

  • Screening pelvic imaging indicating any leiomyomata ≥10 cm in maximum diameter, or uterine size ≥16 cm in length (equivalent to 16 weeks gestation)-note that candidates who exclusively have prior clinical pelvic imaging 12-24 months ago will be excluded if imaging includes leiomyomata ≥9 cm in maximum diameter, or uterine size ≥15 cm in length, presuming leiomyoma growth of ≥1 cm per year
  • Screening pelvic imaging indicating only one, sole leiomyoma <2 cm in maximum diameter
  • Any submucosal leiomyoma that is >50% within uterine cavity (FIGO Type 0 or Type 1 leiomyomata)
  • Visit to the emergency room or hospitalization for leiomyoma symptoms in the last 12 weeks
  • Leiomyomata treated by surgery, radiologic procedure in the last 12 weeks; or plans to undergo any of the above in the next 24 weeks
  • Leiomyomata treated by GRNH agonist or antagonist in the last 12 weeks (if injected) or in the last 4 weeks (if oral); or plans to use the above in the next 24 weeks
  • Currently pregnant or lactating, pregnant or lactating in the past 12 weeks, or planning to become pregnant in the next 24 weeks
  • Screening serum hemoglobin <8 g/dL, or history of blood transfusion in the last 12 weeks (indicating severe anemia)
  • Screening cholesterol lipid panel testing showing LDL cholesterol level ≥ 190 mg/dL (due to rare side effects over long-term use of aromatase inhibitors in postmenopausal women)
  • Screening serum estradiol level <30 pg/mL (consistent with postmenopausal status)
  • For women aged 45 years or older only: irregular menstrual cycles (menstrual cycles <21 days or >38 days between periods), prolonged menstrual bleeding (bleeding >14 days), or bleeding in between menstrual periods, unless already evaluated by a clinician to discuss endometrial biopsy (uterine biopsy) to rule out endometrial hyperplasia.
  • History of osteoporosis (based on self-reported DEXA indicating bone mineral density Z-score < -2.0 at spine, total hip, or femoral neck; a prior fracture judged to be a fragility fracture; or self-reported use of bisphosphonates, calcitonin, calcitriol, ipriflavone, teriparatide, or denosumab for bone density loss)
  • History of severe liver disease (Child Pugh Class C cirrhosis), posing safety risks for use of letrozole
  • Current or prior history of breast cancer (given potential need to take letrozole for breast cancer treatment or secondary prevention)
  • Screening pelvic imaging indicating an Ovarian-Adnexal Reporting and Data System (O-RADS) category 3, 4, or 5 ovarian or adnexal lesion
  • Screening pelvic imaging concerning for other current cancer of the gynecologic, genitourinary or gastrointestinal system
  • Prior hypersensitivity or significant adverse reaction to letrozole or any aromatase inhibitor, or to an ingredient in the placebo capsule
  • Use of letrozole, other aromatase inhibitor, or selective estrogen receptor modulator (SERM) medications in the past 4 weeks, or existing plans to initiate one of these in the next 24 weeks
  • Use of oral, vaginal, or topical exogenous estrogen, progestin, or androgen therapy in the past 4 weeks; or injectable forms of the above in the past 12 weeks; or plans to initiate any of the above in the next 24 weeks
  • Use of medications with potential unsafe interactions with letrozole in the past 4 weeks (methadone, levomethadone, nintedanib, thalidomide), or plans to initiate these in the next 24 weeks
  • Any condition that, in the opinion of the investigators, would interfere with ability to complete study procedures, including acute or uncontrolled mental health condition, substance abuse, or inability to complete procedures in English (or Spanish, for sites that offer study assessments in Spanish)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
实验性的：Letrozole

Oral letrozole 2.5mg/day
药品：Letrozole 2.5mg

Oral letrozole 2.5mg/day
安慰剂比较：Placebo and Letrozole

Placebo capsule for 12 weeks; Oral letrozole 2.5mg/day for 12 weeks
药品：Letrozole 2.5mg

Oral letrozole 2.5mg/day

其他：Placebo

Placebo capsule

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Uterine leiomyoma-related symptom severity over 12 weeks of treatment
大体时间：Baseline to 12 weeks

Change in Uterine Fibroid Symptoms Quality of Life (UFS-QOL) Symptom Severity Scale (SSS) score [Range 8-40 with higher score indicating worse symptoms and worse outcomes]
Baseline to 12 weeks

次要结果测量

结果测量
措施说明
大体时间
Uterine leiomyoma-related quality of life over 12 weeks of treatment
大体时间：Baseline to 12 weeks

Change in Uterine Fibroid Symptoms Quality of Life (UFS-QOL) Health-Related QOL component score [Range 29-145 points, with higher score indicating better QoL and better outcomes]
Baseline to 12 weeks
Total leiomyoma volume over 12 weeks of treatment
大体时间：Baseline to 12 weeks

Change in total leiomyoma volume based on pelvic ultrasound measurements
Baseline to 12 weeks
Total uterine volume over 12 weeks of treatment
大体时间：Baseline to 12 weeks

Change in total uterine volume based on pelvic ultrasound measurements
Baseline to 12 weeks
Symptoms of heavy menstrual bleeding
大体时间：Baseline to 12 weeks

Change in symptoms of heavy menstrual bleeding based on a modified Menstrual Bleeding Questionnaire (MBQ) score [Range 0-48 with higher MBQ score indicating worse symptoms and a negative impact on quality of life]
Baseline to 12 weeks
Improvement in Sexual Functioning
大体时间：Baseline to 12 weeks

Change in pelvic problems-related sexual function as measured by the Sexual Health Outcomes in Women Questionnaire (SHOW-Q) Pelvic Problems Interference subscale score [Range 0-100 with higher scores indicating better sexual function]
Baseline to 12 weeks
Symptoms of pelvic pain
大体时间：Baseline to 12 weeks

Change in pelvic pain severity/intensity "on average" (evaluated on a standard numerical rating scale of 0-10, lower rating indicating better outcomes and less pain)
Baseline to 12 weeks
Symptoms of urogenital distress
大体时间：Baseline to 12 weeks

Change in distressing urogenital symptoms such as urinary frequency, urinary incontinence, and genital pain, as measured by Urogenital Distress Inventory-6 (UDI-6) [Range 0-100 with higher scores indicating higher disability/worse outcomes]
Baseline to 12 weeks
Effect of letrozole on serum cholesterol levels
大体时间：Baseline to 12 weeks

Change in serum LDL cholesterol levels
Baseline to 12 weeks
Effect of letrozole on serum estradiol levels
大体时间：Baseline to 12 weeks

Change in serum estradiol levels
Baseline to 12 weeks
Effect of letrozole on frequency of hot flashes
大体时间：Baseline to 12 weeks

Change in frequency of vasomotor symptoms (hot flashes) as measured by the Hot Flush Rating Scale (HFRS) [no scale range but less # of reported hot flashes indicates better outcome]
Baseline to 12 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of California, San Francisco

合作者

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

调查人员

  • 首席研究员：Vanessa Jacoby, MD, MAS、University of California, San Francisco
  • 首席研究员：Alison Huang, MD, MAS、University of California, San Francisco

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年7月24日

初级完成 (估计的)

2028年9月11日

研究完成 (估计的)

2028年12月11日

研究注册日期

首次提交

2023年11月15日

首先提交符合 QC 标准的

2023年11月15日

首次发布 (实际的)

2023年11月22日

研究记录更新

最后更新发布 (实际的)

2026年10月6日

上次提交的符合 QC 标准的更新

2026年10月5日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 23-39255
  • R01HD112465 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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