Organon And Schering AG To Continue Research In Male Fertility Control Separately

Organon and Schering AG have announced that their research collaboration into a male hormonal contraceptive will conclude at the end of the phase II clinical trial.

Both companies described the collaboration as constructive, but came to the conclusion that the administration route investigated in the trial, which combined an annual implant with three-monthly injections, would unlikely result in a product that would be acceptable for widespread everyday use. Both companies remain committed to research in male contraception and will build on the knowledge gained from the collaboration to seek improvements in how such a contraceptive can be better administered.

The collaboration was announced in November 2002. The phase II trial which started in January 2004, was designed to test the reliability and acceptability of two hormones in combination which were known to have a suppressive effect on sperm production.

Commenting on the collaboration, David Nicholson, executive vice president, Global Research and Development, Organon, said: "The phase II trial was important as it showed that a progestogen combined with testosterone can work as a male contraceptive. Our next step is to find a way to make it easy to use and acceptable to the population.

Phil Smits, senior vice president, Global Business Unit Gynecology and Andrology, Schering, added: "For both Organon and Schering - as well as our clinical and scientific colleagues worldwide - this has been a long and demanding research program. However, we accept the challenge of developing what we have learned so far into a convenient contraceptive method for men. Male fertility control remains an important research area for Schering."

The trial medication and modes of administration were based on results from earlier studies showing that sperm production could be suppressed to contraceptive levels by the progestogen etonogestrel given as a subcutaneous implant, which was developed by Organon. While, at the same time, the resulting testosterone deficiency could be minimized with an injection of long-acting testosterone undecanoate, developed by Schering. Data from the trials will be jointly published upon final analysis.