Prescription of Letrozole for Uterine Myoma
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age21-53
SponsorUniversity of California, San Francisco
About this trial
The PLUM Study is a randomized, double-blinded, 2-arm, parallel-group, placebo-controlled trial is designed to compare the efficacy of letrozole versus placebo on leiomyoma-related symptoms and quality of life as well as leiomyoma and uterine size.
Eligibility criteria
Qualifiers
At least 21 and less than 54 years of age (to focus on an adult, premenopausal population)
Female sex, based on sex identified on their birth certificate (no other gender requirements)
Have uterine leiomyomata that have been visualized on pelvic imaging (i.e., ultrasound or MRI) in the last 24 months
Report symptoms associated with leiomyomata such as heavy uterine bleeding, pelvic pressure or discomfort, urinary or bowel abnormalities, or dyspareunia for the past 3 months
Disqualifiers
Screening pelvic imaging indicating any leiomyomata ≥10 cm in maximum diameter, or uterine size ≥16 cm in length (equivalent to 16 weeks gestation)-note that candidates who exclusively have prior clinical pelvic imaging 12-24 months ago will be excluded if imaging includes leiomyomata ≥9 cm in maximum diameter, or uterine size ≥15 cm in length, presuming leiomyoma growth of ≥1 cm per year
Screening pelvic imaging indicating only one, sole leiomyoma <2 cm in maximum diameter
Any submucosal leiomyoma that is >50% within uterine cavity (FIGO Type 0 or Type 1 leiomyomata)
Visit to the emergency room or hospitalization for leiomyoma symptoms in the last 12 weeks
Trial design
Treatments tested in this trial
- Letrozole 2.5mg
- Placebo
Treatment groups
140 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of California, San Francisco
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov