October 27, 2016

expert reaction to study evaluating the safety and efficacy of a potential contraceptive injection for men

The safety and effectiveness of a male contraceptive injection are assessed in a paper published in the Journal of Clinical Endocrinology & Metabolism with the authors reporting reasonable effectiveness but a relatively high frequency of mild to moderate mood disorders.

Prof. Allan Young, Professor in Mood Disorders, Institute of Psychiatry, Psychology & Neuroscience (IoPPN), King’s College London, said:

“This is an interesting and important study which adds to the body of data about hormonal effects on mood, although the findings will need to be replicated. The adverse effects on mood of an Injectable Combination Hormonal Contraceptive reminds us that men, as well as women, may be subject to effects of reproductive hormones on mood. Mood disorders are serious neuropsychiatric conditions and should be carefully considered when reviewing the risk/benefit ratio of any treatment in this area.”

Prof. Allan Pacey, Professor of Andrology, University of Sheffield, said:

“There is certainly an unmet need for an effective reversible contraceptive for men, along the lines of the hormonal contraceptive for women. However, none of the preparations that have been developed and tested to date have managed to become a commercial reality for one reason or another.

“In this latest study, the authors used a combination of hormones (progesterone and testosterone) to try and take the science forward. Using long-acting injectable forms of these hormones they were able to suppress the production of sperm to a remarkable degree. As such, this contraceptive was extremely effective and therefore certainly has promise.

“However, the fact that so many side effects were observed in the men who were taking part in the trial is of concern. For a male contraceptive to be accepted by men (or women) then it has to be well tolerated and not cause further problems. For me, this is the major concern of this study. But, it is noteworthy that 75% of the men who took part in the trial would be willing to use this method of contraception again. So perhaps the side-effects weren’t all that bad after all.”

Prof. Chris Barratt, Professor of Reproductive Medicine, University of Dundee, said:

“This is high quality research from a very experienced group of investigators, and as there has been no progress in male contraceptives for 40 plus years this is a very significant and welcome development. Additionally, the fact that the study reports relatively low side effects and good ease of use are real world developments. The study involved a reasonable number of patients so the results are likely to be robust.”

Prof. Pierre Bouloux, Professor of Endocrinology, the Royal Free Hospital & member of the Society for Endocrinology, said:

“This is not the first paper of its kind describing the efficacy of combined progestagen therapy with add-back testosterone on reducing spermatozoa concentration to a level likely to be contraceptive. This type of approach is unlikely to be applicable outside the clinical research setting because of the metabolic side effect profile associated with this combination. A sounder approach may be the use of super active gonadotropin-releasing hormone (GnRH) analogues with add-back testosterone.”

‘Efficacy and Safety of an Injectable Combination Hormonal Contraceptive for Men’ by Behre et al. published in Journal of Clinical Endocrinology & Metabolism on Thursday 27th October. 

Declared interests

Prof. Allan Young: No conflicts of interest

Prof. Allan Pacey: “Chairman of the advisory committee of the UK National External Quality Assurance Schemes in Andrology, Editor in Chief of Human Fertility and Trustee of the Progress Educational Trust (all unpaid). Also, recent work for the World Health Organisation, British Broadcasting Corporation, Purple Orchid Pharma (paid consultancy with all monies going to University of Sheffield). Co-applicant on a research grant from the Medical Research Council (ref: MR/M010473/1).”

Prof. Chris Barratt: “I have no conflict of interest- I am a University of Dundee employee and hold MRC grant funding.”

Prof. Pierre Bouloux: None received.