Pilot of Letrozole for Uterine Myomas
Status: | Completed |
---|---|
Conditions: | Cervical Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 21 - Any |
Updated: | 2/14/2019 |
Start Date: | July 2015 |
End Date: | December 2017 |
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).
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).
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
We found this trial at
1
site
San Francisco, California 94143
Principal Investigator: Vanessa Jacoby, MD, MAS
Phone: 415-297-3114
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