This month we had the pleasure of being invited invited to the first meeting of the International Consortium for Male Contraception (ICMC), held in Paris. This was an invitation to researchers and players in the field of male contraception.
Presenters spoke on a number of topics regarding research techniques, social impact, and prospective male methods. But it always came back to this: pharmaceutical companies, governments, and philanthropists were failing. Research is expensive and there needs to be funds in order for progress to happen. Key, however, is that there is no lack of will among scientists. Despite funding obstacles, scientists are working on a number of targets for male contraceptives—albeit at a substantially slower pace than they otherwise could.
You can find summaries of all the presentations here: ICMC Presentations. Dr. David Sokal, our Chair, spoke about reversible vasectomy research, Vasalgel, and two novel oral agents. Some details about the research presented is not included due to confidentiality.
What’s interesting is that researchers are working to initiate a multi-center trial of a combination testosterone / progestin gel which is expected to begin in 2017. If successful, this study would be followed by a Phase 3 study for regulatory approval. It’s excellent if they can succeed, but male hormonal methods have intrinsic limitations that might limit their market appeal, according to pharmaceutical industry folks that we have talked to. Two major limitations are that:
- The hormonal methods require 4 to 5 months before sperm production is sufficiently suppressed to prevent pregnancy, and sperm count monitoring is needed to confirm success.
- About 10% of men are non-responders. To date, there is no way to identify non-responders in advance.
Such limitations might not deter married men from using a male hormonal method, but single men are less likely to be interested.
In addition, serious adverse events related to mood changes led to the halting of a major trial in 2011. Researchers expect that such adverse events can be avoided in the future with different hormonal regimens, and we hope that they are correct, but such adverse events might be a serious obstacle for regulatory approval and market success.
We could be wrong, but we would feel much better if other approaches for developing male contraceptives were getting as much attention and funding as male hormonal methods – even though there are more unknowns for non-hormonal methods, because they are at earlier stages of research. And that’s another issue that the conference raised. Unknowns remain a fear for pharmaceutical companies and other high-capacity institutions.
Eliminating some of the unknowns is a place where we can play a role. We’re already collaborating on a paper looking at the impact of new male contraceptives. To complement this, we’ll be tackling another project to gather new data on acceptability in a younger population of men, i.e. men who are likely to be using contraceptives 10 years from now and who have new attitudes toward gender and family. What side effects are acceptable? How long a wait for effectiveness would be acceptable? What method of delivery is preferred?
These are the types of questions we can try to answer empirically. And updating the answers to those questions should give those with the ability to invest in male contraception the confidence they need to move forward.
Finally, the conference, led by Dr. Serfaty, brought with it another takeaway. Please see below, the Paris Manifesto:
The Paris Manifesto: It’s Time for New Male Contraceptives
Declaration of the International Consortium for Male Contraception (ICMC) on May 4, 2016
at the First ICMC Congress in Paris, at the French National Academy of Medicine
- In 2016, unmet family planning needs remain a global issue. The 2012 London Summit on Family Planning called for innovative solutions for increasing contraceptive access for 120 million women by 2020. Equally important is the development of reliable, reversible and affordable male contraceptives which can be used by millions of sexually active men to allow men to participate in family planning and enhance reproductive health of the couple. Our goal is to help bring to market at least one reliable, reversible and affordable male contraceptive by 2026. While male contraception will not replace female contraception it will improve options to meet couple needs.
- At present male contraception is limited to withdrawal, abstinence, condom use and vas occlusion. However, research has shown that both men and their female partners are willing to use novel methods, including hormonal contraception, provided it is effective, reversible and well tolerated.
- The approaches to male contraception offered by hormonal methods, based on androgens alone or in combination with progestins, are closest to reaching the market. Clinical trials have demonstrated their effectiveness and acceptability by both partners. Researchers targeting differentiation of germ cells, maturation of sperm, or factors inhibiting sperm motility and function, have identified promising targets for non-hormonal male contraception, and clinical data may become available for some of them during the current decade. Developing methods with additional health benefits may increase acceptability and possibly lead to increased use and improved compliance. Also, several novel mechanical approaches to vas occlusion are being developed, one of which might eventually result in a reversible vasectomy.
- The pharmaceutical industry has deserted the field of research in male contraception, partly because of unclear registration requirements and partly because of a perceived lack of acceptability and profitability. Only government, academic and philanthropic nonprofit research organizations are continuing research in this area.
- The authors of the Paris Manifesto urge the pharmaceutical industry and health agencies to become actively involved in the development of male contraceptives. We urge them to join advocacy groups and other stakeholders, as was the case in the development of the first contraceptive pill for women. We appeal to women’s health groups and male health advocates to demand from industry and politicians an active involvement in male contraception. History of the female pill shows that public advocacy led to scientific discovery and success.
- The Paris Manifesto follows the Weimar Manifesto signed by several of the current authors on June 29, 1997 at a Summit Meeting on Male Contraception in Germany. Since then new technologies have made it possible to consider a range of new approaches to male contraception. Now is the time for the pharmaceutical industry, philanthropists and other stakeholders to increase their support for the development of novel methods for men as a high priority on the research agenda for global health, ecologic improvements and economic prosperity.
Signed by: David Serfaty, Founder and Coordinator of the ICMC, Paris, France; Regine Sitruk-Ware, Population Council; USA; Eberhard Nieschlag, University of Münster, Germany; and approved by the Faculty Panel:
Richard A. Anderson, MRC Centre for Reproductive Health, University of Edinburgh, UK; Hermann M. Behre, Martin-Luther-University, Halle, Germany; Philippe Bouchard, University Pierre et Marie Curie, Paris, France; William J. Bremner, University of Washington, Seattle, WA, USA; Kristina Gemzell Danielsson, Karolinska Institutet, Stockholm, Sweden; Martin M. Matzuk, USA; Maria-Cristina Meriggiola, Department of Obstetrics and Gynecology, University of Bologna, Bologna, Italy; Stephanie T Page, University of Washington, Seattle, WA, USA; Nicholas L. Simmons, Baylor College of Medicine, TX, USA; David C. Sokal, Male Contraception Initiative, USA; Ronald Swerdloff, Harbor-UCLA Medical Center Los Angeles, USA; John Townsend, Population Council, USA; Christina Wang, Harbor-UCLA Medical Center Los Angeles, USA; Frederick Wu, University of Manchester, UK