Pilot of Letrozole for Uterine Myomas

Study Overview
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Brief Summary
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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).

Official Title
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Pilot of Letrozole for Uterine Myomas

Conditions
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Leiomyoma, Uterine Fibroids

Intervention / Treatment
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* Drug: Letrozole
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Letrozole<br>Oral letrozole 2.5mg/day | Drug: Letrozole<br> <br> * Other names: Femara;|
| Placebo Comparator: Placebo and Letrozole<br>Intermittent oral letrozole 2.5mg/day for 2 months and an identical placebo capsule for 4 months | Drug: Letrozole<br> <br> * Other names: Femara;Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Fibroid-related Symptoms After Treatment With Letrozole | 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. | Baseline to 2 Months |