Pilot of Letrozole for Uterine Myomas

Last updated: November 4, 2019
Sponsor: University of California, San Francisco
Overall Status: Completed

Phase

4

Condition

Uterine Fibroids

Desmoid Tumors

Leiomyomas

Treatment

N/A

Clinical Study ID

NCT02470741
15-15678
  • Ages > 21
  • Female

Study 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

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 uterinebleeding, 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 allfibroids are less than 4cm (40 mm) each

  5. Fibroids that are ≤7cm in maximum diameter, on screening imaging, if ≤4 fibroids intotal number(fibroid is defined as any mass with radiographic characteristics offibroid >2cm)

  6. Up to date in Pap smear screening and surveillance

  7. Endometrial biopsy (required if age>45 years with irregular bleeding) does notindicate premalignant or malignant cells

  8. Agree to use non-hormonal barrier method of contraception during study period if atrisk 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

Exclusion Criteria:

  1. Fibroids treated by surgery, radiologic procedure, or GnRH agonist or antagonist inthe last 3 months

  2. Any submucosal fibroid ≥2cm that is >50% in uterine cavity (FIGO Type 0 or Type 1fibroids) amenable to hysteroscopic resection

  3. Use of exogenous estrogen and/or progestin in the last month. (for 3 month long-actingdepoprovera 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 inthe 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 orgastrointestinal system

  11. Does not have primary care provider or gynecologist

Study Design

Total Participants: 12
Study Start date:
July 01, 2015
Estimated Completion Date:
December 31, 2017

Connect with a study center

  • University of California, San Francisco

    San Francisco, California 94158
    United States

    Site Not Available

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