Pilot of Letrozole for Uterine Myomas

Summary

PLUM evaluates the drug letrozole as a treatment for uterine fibroids. This study is a randomized, blinded, placebo-controlled trial of oral letrozole among premenopausal women with symptomatic uterine fibroids. Participants will be randomly assigned in a 1:1 ratio to either oral letrozole 2.5mg/day for 6 months (Group A) or intermittent dosing with letrozole 2.5mg/day and an identical placebo capsule (Group B).

Timeline

Start

2015-07

Primary completion

2017-12

Completion

2017-12

Outcome

Missed primary endpoint

registry analysis (superiority test); Letrozole vs Placebo and Letrozole; p = 0.24; Mean Difference (Net) -11.85 (95% CI -32.92 to 9.23) NCT02470741 ↗

Drugs

Indications