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Phase 4 N=12 Randomized Double-blind Treatment

Pilot of Letrozole for Uterine Myomas

Leiomyoma · Uterine Fibroids

Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Changes in Fibroid-related Symptoms After Treatment With Letrozole — -10.42; 1.43 units on a scale — p=0.24

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Letrozole (Drug); Placebo (Other)
Age
Adult, Older Adult · 21+ yrs
Sex
Female
Sponsor
University of California, San Francisco
Primary completion
Dec 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Changes in Fibroid-related Symptoms After Treatment With Letrozole
-10.42; 1.43 0.24

Summary

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).

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02470741). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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