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Research resourcesPartnerships offer promise indeveloping systemic methodsof male fertility regulationArticle by Kirsten M Vogelsong (pictured), Henry L Gabelnick and Eberhard NieschlagIn response to the Programme of Action approved by 179countries at the International Conference on Population andDevelopment (ICPD) held in Cairo in 1994, an increasingemphasis is being placed on free reproductive choice, genderequity and greater male participation in sexual and reproductivehealth and family planning programmes worldwide. Onemeans by which to promote partnerships with men in familyplanning is through increasing options by the development ofsafe, effective and acceptable methods of contraception formen to use.Men around the world, in a variety of countries and settings,are aware of the existence and use of methods of familyplanning; many support their sexual partners in using thefamily planning methods of their choice. On a global level, ofthe more than one billion married women of reproductive age,approximately 60% are using any method of family planning.Most of these women report using methods that theythemselves initiate, with fewer couples relying on the use ofcondoms (about 5%) or vasectomy (about 3.5%) to planwhether and when to have children. However, these numberspresent a limited view of male participation in contraceptivebehaviour, since traditional methods like rhythm andwithdrawal (each relied upon by approximately 3% of marriedwomen of reproductive age) also require the male partner’scooperation. Significant country and regional differences in therates of use of these methods do exist, with vasectomy,condoms and withdrawal all used by a higher proportion ofcouples in more developed regions of the world 1 .At least 120 million couples around the world do not use anymethod of family planning, despite a desire to avoid apregnancy. This unmet need for family planning is especiallyapparent in the developing world and is probably symptomaticof a variety of shortcomings in the available health care systems(lack of knowledge about contraception, lack of services ortrained medical personnel, limited supplies) as well as thelimitations of the methods themselves including real orperceived health effects, and personal and cultural objections tothe use of existing contraceptive technologies.In early 2007, the All Party Parliamentary Group onPopulation, Development and Reproductive Health of theUnited Kingdom launched its report Return of the PopulationGrowth Factor – Its Impact Upon the Millennium DevelopmentGoals. The evidence gathered and reported by this groupdemonstrates that it is essential to address and meet theincreasing needs for family planning worldwide, in order toachieve these international goals. The recommendationsinclude promotion of gender equality and sustained provision ofcontraceptive commodities 2 .The World Bank, too, has recently presented updatedevidence linking population and development and has againcommitted to working with government, country and UnitedNations partners to address family planning issues at thehighest levels of country policy-setting 3 .Traditionally, women have assumed the responsibility forfamily planning. However, many women do not have access tothe most effective methods, find their side-effects intolerable, orwould simply prefer to share this role with a partner. For theirpart, a significant proportion of men report a willingness to usea method to regulate their own fertility in repeated surveys invarious countries and settings, with the most recent researchconducted in Europe, the USA, Latin America and Indonesia 4and the UK, China and South Africa 5 . The Programme ofAction from the ICPD calls for increased research to developmale methods, in order to better meet individuals’ needs andrights in reproductive health 6 .For more than three decades, the public sector has beenworking in collaboration with major pharmaceuticalcompanies, small independently-owned companies, not-forprofitorganizations and academic scientists on a researchagenda geared towards the development of safe, effective andacceptable methods to regulate male fertility. Since familyplanning programmes that offer a wider variety of methods aremore successful in meeting the contraceptive needs of couples,making a method available for men to use could address theneeds of a significant number of couples who are not using anymethod, or who are unsatisfied with the methods available.Successfully regulating male fertility can be achieved byexploiting one or more of several aspects of male reproduction,as long as sperm are prevented from reaching an egg in awoman’s reproductive tract. Following the resurgence incondom promotion associated with the public healthemergency of the HIV/AIDS pandemic, improved condomshave been developed, using innovative designs and alternativematerials, with the goal of increasing acceptability and,therefore, use 7,8 .In addition, researchers and small companies have128 ✜ Global Forum Update on Research for Health Volume 4
Research resourcesinvestigated the vas deferens as a site of male contraception,particularly to develop alternative approaches to malesterilization 9 . The goal of this line of research is to makeavailable, effective methods associated with less tissue trauma,faster recovery, and fewer side-effects with, in some cases,improved probability of reversal. The VasClip ® was approved formarketing in the USA in 2002, but is not widely available inthat country and not available at all outside of the USA.Research on vasectomy techniques has provided informationon the most successful surgical approaches 10 and studies onother physical or chemical devices to block the vas are ongoing.To date, no method is more effective, safer or more acceptablethan the no-scalpel vasectomy technique, developed in Chinain 1974 and introduced outside of China in the mid-1980s.A novel approach to male contraception is through hormonalmanipulation of the process of sperm production. Datacollected over the last 20 years have demonstrated the proof ofthe concept of using steroid hormones to disrupt spermproduction in men. Exogenous androgens were initially used tosuppress the hypothalamic engine of spermatogenesis 11,12 .Long-acting androgens offer a viable method of male fertilityregulation in Chinese populations 13 ; a regimen of monthlyinjections of testosterone undecanoate is currently beingevaluated in a Phase III safety and efficacy trial in 10 centresin China, supported by the World Health Organization, theChinese Government and the drug manufacturer. Combinedprogestin and androgen regimens have been investigated asbeing more effective, and possibly safer, for a global audience 14and may very well offer the best opportunity for a marketablemale contraceptive product in the medium-term future 15 .The World Health Organization, in partnership with the USAbasedCONRAD program, is currently working to initiate aninternational, multicentre Phase II clinical trial of the safety andcontraceptive efficacy of one such combined hormonalregimen. In small preliminary studies, injections of theprogestin norethisterone enanthate, when given together withinjections of the long-acting androgen testosteroneundecanoate (both provided by Schering AG, now BayerSchering Pharma), produced profound decreases in spermoutput in men with no serious side effects 16,17,18 . The plannedstudy will enroll 400 couples in eight countries to test theefficacy of the regimen when administered every eight weeks;we expect the pregnancy rate to be no greater than the failurerate of combined oral contraceptives. Because each of thecompounds is widely marketed, we do not anticipate anyserious risks or side-effects. If enrolment can begin before theend of 2007, as planned, final study results should beavailable in 2011. Keeping in mind the service delivery aspectof product development, if the results of the planned study arepromising, the study sponsors are interested to develop acombined, single injection for delivering the steroid hormonesand will test a novel formulation in a follow-on clinical trial, iffunds can be raised.Only a handful of pharmaceutical companies have beenactively engaged in contraceptive research and development;even fewer have supported research on methods to regulate malefertility. In 1997, investigators researching hormonal regimens ofcontraception for men urged the pharmaceutical industry tobecome actively involved in this exciting and promising field ofwork 19 . Around this time, the large European companies Organon(Oss, the Netherlands) and Schering AG (Berlin, Germany)initiated clinical research on hormonally-based methods offertility regulation for men and, in 2002, the two companieslaunched a collaborative initiative to conduct a clinical trial toexplore the safety and efficacy of a combined hormonal methodof male contraception. Each company also planned to pursueindependent avenues of research related to male fertilityregulation, as did Wyeth (Madison, New Jersey, USA).Schering’s not-for-profit arm, the Ernst Schering Foundation,in collaboration with the Rockefeller Foundation, had alreadymade substantial investments in basic science research relatedto regulation of the male reproductive system, in particularpost-testicular activity. The AMPPA (application of molecularpharmacology for post-testicular activity) network, establishedin 1997, proved so successful in identifying new targetssuitable for drug discovery in male contraception that theproject was renewed in 2002, with CONRAD replacing theRockefeller Foundation as funding partner for the AMPPA-II(application of molecular pharmacology for post-meioticactivity) network. AMPPA-II supported work in identifying novelepididymal and testicular targets that could be exploited in thedevelopment of male contraceptives; several approaches wereselected for continued support to evaluate target validation.The significant corporate commitment to research anddevelopment of a method for male use in contraception was asignal of confidence in the potential market for such a product.In a collaborative process, pharmaceutical companies,investigators and donors have proposed recommendations forregulatory review and approval of a potential method of malefertility regulation 20 .Despite their combined efforts and achievements, however,the collaboration between Schering and Organon came to aclose following completion of the clinical trial in 2006, and allthe large companies and their subsidiaries have phased outtheir programmes of research and development on male fertilityregulation, for various reasons. Both Schering and Organonwere bought by larger pharmaceutical companies that realignedtheir respective research portfolios. Even the AMPPA-IInetwork has been terminated, due to lack of funding and thechange in corporate ownership at Schering. This puzzlingtransformation of research priorities in the private sector hasmade the efforts of the public sector and research institutionsparamount in the search for new methods of family planning tomeet couples’ needs.The United States National Institute of Child Health andHuman Development, part of the National Institutes of Health,has established a Cooperative Research Program on MaleFertility Regulation, which supports basic, applied and clinicalresearch. The Institute funds research on topics that arerelevant to both short-term and long-term productdevelopment. This research initiative may very well lead to thedevelopment of a non-hormonal method of male fertilityregulation, with targeted action and few side-effects, which willbe an essential component of the range of methods required tomeet the contraceptive needs of the next generation of youngpeople entering their reproductive years.Global Forum Update on Research for Health Volume 4 ✜ 129
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