Prescription of Letrozole for Uterine Myoma (NCT06143631) | Clinical Trial Compass
RecruitingPhase 4
Prescription of Letrozole for Uterine Myoma
United States140 participantsStarted 2024-07-24
Plain-language 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.
Who can participate
Age range21 Years – 53 Years
SexFEMALE
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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 regularly occurring menstrual periods of ≤ 14 days duration with a cycle of 21 to 38 days from the start of one menstrual period until the start of the next, by patient history for at least 3 months prior to screening
* 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…
What they're measuring
1
Uterine leiomyoma-related symptom severity over 12 weeks of treatment