Letrozole for Treatment of Uterine Fibroids: A Randomized, Placebo-Controlled 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.
• 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)