Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

San Francisco, California 94158


Purpose:

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).


Criteria:

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


NCT ID:

NCT02470741


Primary Contact:

Principal Investigator
Vanessa Jacoby, MD
University of California, San Francisco


Backup Contact:

N/A


Location Contact:

San Francisco, California 94158
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 24, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.