Pilot of Letrozole for Uterine Myomas
- Registration Number
- NCT02470741
- Lead Sponsor
- University of California, San Francisco
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 12
- ≥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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo and Letrozole Placebo Intermittent oral letrozole 2.5mg/day for 2 months and an identical placebo capsule for 4 months Placebo and Letrozole Letrozole Intermittent oral letrozole 2.5mg/day for 2 months and an identical placebo capsule for 4 months Letrozole Letrozole Oral letrozole 2.5mg/day
- Primary Outcome Measures
Name Time Method Changes in Fibroid-related Symptoms After Treatment With Letrozole 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of California, San Francisco
🇺🇸San Francisco, California, United States