SPECIAL REPORT Evidence for the Acceptability of an Injectable Hormonal Method for Men By Karin Ringheim he search for a safe, effective and re- relationships received weekly injections of the century.5 No studies have examined versible hormonal method of fertil- of 200 mg of testosterone enanthate. Those the important question of whether the Tity regulation for men has been un- who became azoospermic (65%) continued method will find acceptors, but the atti- derway for more than 20 years. Several with weekly injections for a period of 12 tudes and opinions of men who partici- publicly supported and international bio- months, during which the contraceptive pated in the clinical trials may provide medical research organizations, including efficacy of the method was assessed. Azoo- helpful insights. the World Health Organization (WHO), spermia was associated with near perfect This report presents information as the Population Council, the Contraceptive contraceptive efficacy (just 0.8 conceptions gleaned from focus group discussions and Research and Development Program, per 100 person years).2 questionnaires completed by men who vol- Family Health International and the Na- A second study investigated whether unteered for the trials. The shortcomings tional Institutes of Health, have conduct- this state of complete azoospermia was nec- of the present formulation and the plans to ed or supported research in this area in de- essary for contraceptive efficacy. Between address them are important to keep in mind veloped and developing countries. As a 1990 and 1994, 15 centers in nine countries when assessing the observations of the early result, a variety of hormonal compounds participated in a study in which men also clinical trial participants. Nonetheless, the and contraceptive delivery systems, in- received weekly injections of 200 mg of findings add to an extremely limited body cluding injections, pills, implants and testosterone enanthate, but the 12-month of evidence indicating that there may be a patches, are currently under investigation. contraceptive efficacy assessment stage niche among contraceptive users for a hor- Many factors, however, including lim- was initiated sooner—when men reached monal method for men. ited funding and a lack of commercial in- a state of oligozoospermia (less than three terest in male fertility regulation, have million sperm/ml). The vast majority (97%) Information Sources slowed progress. Pharmaceutical compa- of the 289 men who remained in the study Focus group discussions, which are struc- nies reportedly doubt that a market exists for six months achieved this level of sub- tured by a relatively strict set of guidelines for hormonal contraceptives for men and fertility, and their subsequent experience and procedures, are useful for gathering in- fear the potential for litigation.1 demonstrated that complete azoospermia formation about values and beliefs and for Nonetheless, clinical trials of a hormonal was unnecessary to achieve an acceptable gaining a better understanding of prefer- method, supported by WHO, have shown contraceptive efficacy.3 ences and motivation.6 Six of the oligo- encouraging results. Between 1986 and While testosterone enanthate has been zoospermia clinical trial centers were in- 1990, 10 centers in seven countries com- valuable in establishing the viability of a vited to conduct focus groups, and four pleted a clinical trial demonstrating the hormonal agent for male contraception, it centers agreed—Sydney, Bangkok, Singa- contraceptive efficacy of azoospermia (or has several drawbacks, including the need pore and Edinburgh. All men who had par- the absence of sperm) induced by testos- for frequent injections and for a relatively ticipated in the clinical trials—an average terone enanthate, a drug long used to treat long period (3–4 months, on average) to of 10–20 per center—were invited to attend. hypogonadal men. In that trial, 271 healthy achieve oligozoospermia; it also has a Because these focus groups were held at a fertile men aged 21–45 who were in stable pharmacokinetic profile that produces minimum of several months after the trial above-normal testosterone levels imme- ended, many of the original participants Karin Ringheim is a Senior University of Michigan In- diately following each injection. Thus, in were no longer near the center. The 23 men ternational Population Fellow in the Research Division of the Office of Population, United States Agency for In- future trials testosterone enanthate will be who did attend the discussions—approx- ternational Development (USAID), Washington, D.C. At combined with another hormone (such as imately 5–6 from each center—were those the time this report was written, she was a scientist with DMPA), to shorten the time needed to who were available and interested. the Task Force for Social Science Research on Repro- achieve a contraceptive effect, or a new for- The focus group discussion guide in- ductive Health, World Health Organization (WHO), Geneva. This article is based on a report to the Task Force mulation (such as testosterone buciclate, cluded as topics the participants’ contra- on Methods for the Regulation of Male Fertility of WHO’s which requires less frequent injections and ceptive histories, communication with Special Programme on Research, Development and Re- does not produce a physiological peak4) their partner, and decision-making pat- search Training in Human Reproduction. Analysis of the will be used. terns. A primary interest was to gain the data was supported by the Office of Population, USAID. The author would like to thank G. M. H. Waites and Researchers believe that with a full-scale perspective of these “experts” to help de- David Griffin of WHO, the leaders of the focus groups effort, a newly-formulated product could velop acceptability studies for future clin- and the men who participated in the clinical trials. be ready for introductory trials by the turn ical trials of methods for men. Content Volume 21, Number 2, June 1995 75 Acceptability of a Hormonal Method for Men analysis, the key to the full utilization of be constantly attending to contraceptive focus group transcripts, was hampered to Table 1. Percentage and number of respon- options, mindful of the need to be diligent, dents in a 1990–1994 multicountry study of a some extent by variations in moderators male injectable contraceptive, by responses and acutely aware of, and disappointed by, adhering to the discussion guide. to items on a follow-up questionnaire the limited range of choices. The contra- Questionnaires completed by partici- ceptive histories of focus group partici- pants 12 months after completion of the Item % No. pants revealed a wide experimentation oligozoospermia trial as part of the on- Main reason for participation with methods, and subsequent difficulties Needed a change in going follow-up examination are anoth- contraceptive method 36 55 or dissatisfactions with nearly all of them. er source of data. Thus far, 154 participants Partner or spouse encouraged me 23 35 The questionnaire respondents reported have responded—81 from China, 41 from Doctor encouraged me 23 36 having used an average of 2.4 methods each; Belief in male responsibility 6 9 Australia, 13 from the United Kingdom, Desire to try new things 5 8 the number is probably an underestimate, 13 from the United States, three from Sin- Interest/belief in male methods 3 4 since it is based on men’s recollection or gapore and three from Thailand. The Friend/relative encouraged me 3 4 knowledge of a partner’s use of methods. Interest in scientific research 1 2 questionnaires, which included multiple Money was important 1 1 The pill was the predominant method used choice items on what motivated the men All 100 154 by the partners of Australian, U.K. and U.S. to participate in the trials and on their con- How heard about study respondents, while the IUD was the meth- traceptive histories, also provided an op- Doctor 34 53 od most frequently used by the partners of portunity to write in comments, and a few Newspaper 23 35 the Chinese men. At the time of the study, Group dissemination* 15 23 of these remarks are quoted here. Friend 12 18 the contraceptive implant was virtually un- Television/radio 10 16 known by respondents outside of China, Motivation for Participation Spouse or partner 3 4 and only two questionnaire respondents Clinic/health professional 2 3 Sharing Responsibility Poster 1 2 said their partner had ever used an in- The investigators knew full well that a reg- All 100 154 jectable contraceptive. imen requiring weekly and often painful Methods used in past† Almost 80% of the men who respond- injections would be impractical and un- Condom 84 129 ed to a question on whether previous Pill 56 86 acceptable as a method of fertility regula- IUD 40 61 problems with a method had influenced tion. Therefore, an acceptability study of Diaphragm/cap/sponge 24 37 their participation in the study replied af- the method as it was delivered during the Rhythm 23 35 firmatively. While this finding reflects a Withdrawal 8 13 clinical trial would be premature. Bio- Implant 4 6 self-selection factor, it also points to the medical and social scientists were nonethe- Injection 1 2 need for advances in contraceptive de- less intrigued by what motivated men to velopment, including the refinement of ex- *Among the 81 Chinese participants only. †Multiple responses could join such a study. Were they representative be given. Note: The questionnaire was administered 12 months isting methods, such as the pill, that con- after completion of the latest trial in 1994; responses are still being of a societal fringe element? Were they sim- received, and the total number of respondents may increase. tinue to cause side effects. ply risk-takers? Or do-gooders? Men who completed the oligozoosper- Problems with the Pill mia follow-up questionnaire were asked wife or partner to join the study, that part- Nearly every focus group participant to identify the main reason they joined the ner frequently had a history of contracep- whose partner had used the pill men- study.