Leuprolide

Does Leuprolide work?

Yes, in large controlled trials.

Leuprolide has four decades of controlled trials behind its prostate cancer, endometriosis, and precocious puberty indications, summarized in the adult and pediatric labels. The cited 2012 study is a randomized phase 3 trial in 84 children with precocious puberty comparing two strengths of the three-month depot, which is also the largest trial cited. The citations are thin on the original randomized prostate cancer trials, but the approvals and the labels rest on them. ¹²³

A 2012 phase 3 trial randomized 84 children with central precocious puberty at 22 US centres. They got one of two strengths of a three-month leuprolide depot, open-label, for six months. Peak stimulated LH is the marker that shows the pubertal signal is switched off. It was suppressed from month 2 through month 6 in 78.4% of children on the lower strength. On the higher strength it was 95.2%. Sex-hormone suppression, growth rate, pubertal progression and adverse events were similar at both strengths. ¹

In prostate cancer, the labeled trials show testosterone falling to castrate levels in nearly all men within a few weeks. It stays there for the depot interval. That level is the surrogate measure on which the various depot forms were approved. ²

Read the full Leuprolide page

Reference information only, not medical advice. Drawn from the Leuprolide article, fact-checked against the cited sources. No dosing anywhere on this site.