Comparing Oral Letrozole and Placebo for Treatment of Uterine Fibroids Symptoms and Size in Adult Premenopausal Women

What this Trial Is About

Researchers are evaluating the effects of letrozole compared to a placebo in adult premenopausal women who have uterine fibroids leiomyomas. The study aims to understand how letrozole influences symptoms related to fibroids, quality of life, and changes in the size of fibroids and the uterus over a 12-week treatment period. This Phase 4, randomized, double-blind, placebo-controlled trial is designed to provide detailed information about symptom severity and physical changes in patients with leiomyomas. Participants are randomly assigned to one of two groups one receiving oral letrozole 2.5 mg daily for 12 weeks, and the other receiving a placebo capsule for 12 weeks followed by letrozole 2.5 mg daily for 12 weeks. The study uses a parallel-group design with triple masking to ensure unbiased results. The treatment period lasts 12 weeks, during which participants take the assigned capsules daily. During the study, participants undergo assessments of their fibroid-related symptom severity and quality of life using standardized measures. Researchers also monitor changes in total fibroid volume and uterine size via imaging, as well as symptoms like heavy menstrual bleeding, pelvic pain, sexual function, and urogenital distress. Blood tests measure cholesterol and estradiol levels, and hot flash frequency is tracked. The study lasts approximately 12 weeks of treatment with ongoing safety monitoring and outcome evaluations.

Prescription of Letrozole for Uterine Myoma