Letrozole for Treatment of Uterine Fibroids: A Randomized, Placebo-Controlled Trial
University of California, San Francisco
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
- Age range
- 21–53 years
- Sex
- Female
- Healthy volunteers
- Yes
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 a…
Interventions
- DrugLetrozole 2.5mg
Oral letrozole 2.5mg/day
- OtherPlacebo
Placebo capsule
Locations (5)
- University of California, Los AngelesLos Angeles, California
- University of California, San FranciscoSan Francisco, California
- Mayo ClinicRochester, Minnesota
- University of Mississippi Medical CenterJackson, Mississippi
- Duke UniversityDurham, North Carolina