Pilot of Letrozole for Uterine Myomas
Condition: Leiomyoma; Uterine Fibroids
MeSH terms: Leiomyoma; Myofibroma
Intervention: Letrozole; Placebo
Intervention MeSH terms: Letrozole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 12.0
Sex: Female
Minimum age: 21 Years
Healthy volunteers: No

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:

          1. ≥21 years old

          2. Premenopausal (at least one menses in last 3 months)

          3. Symptomatic fibroids (fibroids visualized on ultrasound or MRI and heavy uterine
             bleeding, pelvic pressure or discomfort, urinary or bowel abnormalities, dyspareunia)

          4. 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

          5. 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)

          6. Up to date in Pap smear screening and surveillance

          7. Endometrial biopsy (required if age>45 years with irregular bleeding) does not
             indicate premalignant or malignant cells

          8. Agree to use non-hormonal barrier method of contraception during study period if at
             risk for pregnancy

          9. Has primary care provider or gynecologist

         10. Agrees not to start new medications/treatments for fibroids during the study

         11. Able to give informed consent

        Exclusion Criteria:

          1. Fibroids treated by surgery, radiologic procedure, or GnRH agonist or antagonist in
             the last 3 months

          2. Any submucosal fibroid ≥2cm that is >50% in uterine cavity (FIGO Type 0 or Type 1
             fibroids) amenable to hysteroscopic resection

          3. Use of exogenous estrogen and/or progestin in the last month. (for 3 month long-acting
             depoprovera injection, no use in last 3 months)

          4. Pregnant, lactating, or planning to become pregnant in the next 6 months

          5. Hematocrit <27% or visit to emergency room or hospitalization for fibroid symptoms in
             the last 3 months (cannot be safely randomized to a placebo)

          6. History of osteopenia or osteoporosis

          7. History of hyperlipidemia

          8. Current liver or kidney disease

          9. Unable or unwilling to attend 4 study visits

         10. Pelvic imaging concerning for gynecologic cancer or cancer of the genitourinary or
             gastrointestinal system

         11. Does not have primary care provider or gynecologist