Pilot of Letrozole for Uterine Myomas

Completed · Phase 4 · Has a placebo group

Conditions studied: Leiomyoma, Uterine Fibroids

In brief

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).

Key facts

Study ID

NCT02470741

Run by

University of California, San Francisco

People needed

12

Starts

2015-07-01

Expected to finish

2017-12-01

Last updated by the study team

2019-11-15

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• ≥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

You may not qualify if…

• 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

Where it is running

• University of California, San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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