Two Phase III Clinical Trials on Corifollitropin Alfa Reach Randomization Target

Organon, the human healthcare business unit of Dutch drug company Akzo Nobel, announced that two of the three Phase III clinical trials with corifollitropin alfa, a long-acting fertility hormone, reached their randomization target.

Corifollitropin alfa (Org 36286) is a new recombinant fertility hormone. It is the first of a new class of gonadotropins. Due to its long half-life, a single injection may replace the first seven injections with conventional gonadotropins during a fertility treatment cycle, according to Organon.

The objective of the ENGAGE trial, which the company said is the largest double-blind fertility trial ever performed, is to demonstrate clinical efficacy and safety of corifollitropin alfa 150 micrograms in a double-blind comparison with Organon’s Puregon, one of the most commonly used preparations to treat infertile patients, the company said.

The recruitment goal of the ENGAGE trial was to include a total of 1,400 patients from 34 fertility clinics in Europe, the U.S. and Canada. The study reached its randomization target June 10, the company said.

A second trial, the ENSURE trial, is an efficacy and safety trial with corifollitropin alfa 100 micrograms designed specifically for women who weigh less than 133 lbs. This double-blind study in 19 clinical trial centers in Europe and Asia met its recruitment goal of 330 patients, all of whom have been randomized, the company said.

A third Phase III trial, the TRUST trial, will focus on the safety of repeated treatments with corifollitropin alfa, and is expected to complete recruitment by mid-August, the company said.