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Recruiting
NCT06143631
Prescription of Letrozole for Uterine Myoma
Conditions: Leiomyoma, Uterine, Leiomyoma, Fibroid, Fibroid Uterus
Sex: Female
Ages: 21 Years – 53 Years
Healthy volunteers: Yes
Phase: PHASE4
Enrollment: 140
Sponsor: University of California, San Francisco
Location: University of California, Los Angeles Los Angeles California
Summary
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
Inclusion Criteria:
* 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
* Have at least moderate leiomyomata symptom burden, with UFS-QOL SSS score of 30 or higher at baseline
* Has had a menstrual period in the past 3 months (90 days)
* Agree to use a non-hormonal or barrier method of contraception with any sexual activity with a non-sterile male partner during the study period (i.e., use of copper IUD is consistent with eligibility)
Exclusion Criteria:
* 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 \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
* Leiomyomata treated by surgery, radiologic procedure in the last 12 weeks; or plans to undergo any of the above in the next 24 weeks
* Leiomyomata treated by GRNH agonist or antagonist in the last 12 weeks (if injected) or in the last 4 weeks (if oral); or plans to use the above in the next 24 weeks
* Currently pregnant or lactating, pregnant or lactating in the past 12 weeks, or planning to become pregnant in the next 24 weeks
* Screening serum hemoglobin \
Source: ClinicalTrials.gov (NCT06143631). StuddyBuddy aggregates publicly available trial information.