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OpenTrials
Completed

NCT Number: NCT02470741

Pilot of Letrozole for Uterine Myomas

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).

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Key information

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of California, San Francisco

San Francisco, California, 94158, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥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

Exclusion criteria

  • 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

Treatment and study plan

letrozole

Drug

Other names: Femara

Placebo

Other

Primary outcomes

  1. Changes in Fibroid-related Symptoms After Treatment With Letrozole

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Acronym: PLUM

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 12, 2015
Registry last updated
Nov 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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