Evidence for the acceptability of an injectable hormonal method for men

Ringheim, Karin

The search for a safe, effective and reversible hormonal method of fertility regulation for men has been under way for more than 20 years. Several publicly supported and international biomedical research organizations, including the World Health Organization (WHO), The Population Council, the Contraceptive Research and Development Program, Family Health International and the National Institutes of Health, have conducted or supported research in this area in developed and developing countries. As a result, a variety of hormonal compounds and contraceptive delivery systems, including injections, pills, implants and patches, are currently under investigation.

Many factors, however, including limited funding and a lack of commercial interest in male fertility regulation, have slowed progress. Pharmaceutical companies reportedly doubt that a market exists for hormonal contraceptives for men and fear the potential for litigation.(1)

Nonetheless, clinical trials of a hormonal method, supported by WHO, have shown encouraging results. Between 1986 and 1990, 10 centers in seven countries (Australia, China, Finland, France, Sweden, the United Kingdom and the United States) completed a clinical trial demonstrating the contraceptive efficacy of azoospermia (or the absence of sperm) induced by testosterone enanthate, a drug long used to treat hypogonadal men. In that trial, 271 healthy fertile men aged 21-45 who were in stable relationships received weekly injections of 200 mg of testosterone enanthate. Those who became azoospermic (65%) continued with weekly injections for a period of 12 months, during which the contraceptive efficacy of the method was assessed. Azoospermia was associated with near-perfect contraceptive efficacy (just 0.8 conceptions per 100 person-years).(2)

A second study investigated whether this state of complete azoospermia was necessary for contraceptive efficacy. Between 1990 and 1994, 15 centers in nine countries (Australia, China, France, Hungary, Singapore, Sweden, Thailand, the United Kingdom and the United States) participated in a study in which men received weekly injections of 200 mg of testosterone enanthate, but the 12-month contraceptive efficacy assessment stage was initiated sooner--when men reached a state of oligozoospermia (less than three million sperm/ml). The vast majority (97%) of the 289 men who remained in the study for six months achieved this level of subfertility, and their subsequent experience demonstrated that complete azoospermia was unnecessary to achieve an acceptable level of contraceptive efficacy.(3)

While testosterone enanthate has been valuable in establishing the viability of a hormonal agent for male contraception, it has several drawbacks, including the need for frequent injections and for a relatively long period (3-4 months, on average) to achieve oligozoospermia; it also has a pharmacokinetic profile that produces above-normal testosterone levels immediately following each injection. Thus, in future trials, testosterone enanthate will be combined with another hormone (such as DMPA) to shorten the time needed to achieve a contraceptive effect, or a new formulation (such as testosterone buciclate, which requires less frequent injections and does not produce a physiological peak(4)) will be used instead.

Researchers believe that with a full-scale effort, a newly formulated product could be ready for introductory trials by the turn of the century.(5) No studies have examined the important question of whether the method will find acceptors, but the attitudes and opinions of men who participated in the clinical trials may provide helpful insights.

This report presents information gleaned from focus group discussions and questionnaires completed by men who volunteered for the trials. The shortcomings of the present formulation and the plans to address them are important factors to keep in mind when assessing the observations of the early clinical trial participants. Nonetheless, the findings add to an extremely limited body of evidence indicating that there may be a niche among contraceptive users for a hormonal method for men.

Information Sources

Focus group discussions, which are structured by a relatively strict set of guidelines and procedures, are useful for gathering information about values and beliefs and for gaining a better understanding of preferences and motivation.(6) Six of the oligozoospermia clinical trial centers were invited to conduct focus groups, and centers in four countries agreed--Australia, Singapore, Thailand and the United Kingdom. All men who had participated in the clinical trials--an average of 10-20 per center--were invited to attend. Because these focus groups were held a minimum of several months after the trial ended, many of the original participants were no longer near the center. The 23 men who did attend the discussions--approximately 5-6 from each center--were those who were available and interested.

The focus group discussion guide included as topics the participants' contraceptive histories, communication with their partner and decision-making patterns. A primary interest was to gain the perspective of these "experts" to help develop acceptability studies for future clinical trials of methods for men. Content analysis, the key to the full utilization of focus group transcripts, was hampered to some extent by variations in the extent to which moderators adhered to the discussion guide.

Questionnaires completed by participants 12 months after completion of the oligozoospermia trial as part of the ongoing follow-up examination are another source of data. Thus far, 154 participants have responded--81 from China, 41 from Australia, 13 from the United Kingdom, 13 from the United States, three from Singapore and three from Thailand. The questionnaires, which included multiple-choice items on what motivated the men to participate in the trials and on their contraceptive histories, also provided an opportunity to write comments in, and a few of these remarks are quoted here.

Motivation for Participation

Sharing Responsibility

The investigators knew full well that a regimen requiring weekly and often painful injections would be impractical and unacceptable as a method of fertility regulation. Therefore, an acceptability study of the method as it was delivered during the clinical trial would be premature. Biomedical and social scientists were nonetheless intrigued by what motivated men to join such a study. Were they representative of a societal hinge element? Were they simply risk-takers? Or do-gooders?

Men who completed the oligozoospermia follow-up questionnaire were asked to identify the main reason they joined the study. As Table 1 shows, (Table 1 omitted) 36% reported that they needed a change in their contraceptive method and 23% said that their spouse or partner had encouraged their participation. About 9% were interested specifically in men's responsibility in contraceptive practice or believed in the importance of developing a male method. A few were motivated by a desire to try new things. One questionnaire respondent expressed a view that many seemed to share: "[I am] always looking for contraception that is suitable for both of us."

Participants learned about the study through a variety of personal and media contacts, as the table shows. (Table omitted) More than one-third of the men (34%) reported that they had heard about the study through their doctor, including nearly one-half of the participants from China. (More than one-quarter of Chinese participants learned about the study through "group dissemination.") Most other participants heard about it through the newspaper, television or radio, or from a friend.

When men were encouraged by their wife or partner to join the study, that partner frequently had a history of contraceptive problems. In fact, the overwhelming majority of questionnaire respondents indicated that "doing a good thing for my partner" by using a male method was a "very important" motivational factor for them. All but two of the 154 respondents indicated that this motivating factor was at least "somewhat important."

The men's motivation for participating in the trial was explored in more depth in the focus groups. Because many men mentioned their contraceptive history as a couple, their motivation and contraceptive experience merged as themes in the discussions:

"My wife had been taking the pill for nine years. I felt that she was helpless, so why shouldn't it be my turn?"

"When she takes the pill and it does something to her, I don't feel good."

These findings suggest that there may be a reservoir of men who are motivated less by a desire to control their own fertility than by a genuine desire to ease the contraceptive burden that has been largely shouldered by their partners.

The men and their partners appeared to be constantly attending to contraceptive options, mindful of the need to be diligent, and acutely aware of, and disappointed by, the limited range of choices. The contraceptive histories of focus group participants revealed a wide experimentation with methods, and subsequent difficulties or dissatisfactions with nearly all of them.

The questionnaire respondents reported having used an average of 2.4 methods each; the number is probably an underestimate, since it is based on men's recollection or knowledge of a partner's use of methods. The pill was the predominant method used by the partners of Australian, U. K. and U.S. respondents, while the IUD was the method most frequently used by the partners of the Chinese men. At the time of the study, the contraceptive implant was virtually unknown by respondents outside of China, and only two questionnaire respondents said their partner had ever used an injectable contraceptive.

Almost 80% of the men who responded to a question on whether previous problems with a method had influenced their participation in the study replied affirmatively. While this finding reflects a self-selection factor, it also points to the need for advances in contraceptive development, including the refinement of existing methods, such as the pill, that continue to cause side effects.

Problems with the Pill

Nearly every focus group participant whose partner had used the pill mentioned that she had had one or more of the following side effects--nausea, weight gain, depression, acne, liver spots, mood swings, painful periods, diminished libido, headaches, cramping and "feeling unwell" in general.

As a result, discussants often mentioned that they were anxious to relieve their wives of the need to take the pill:

"My wife taking estrogen was like the shrew that couldn't be tamed. She would wake up depressed...and after a period of time I said, 'Honey, it's the pill, stop taking it, I don't care, I'1l use condoms, or other forms of birth control, I'11 go on the program that my friend is on, but you stop taking the pill right now...'"

"I thought that I should be shouldering my share of the responsibility for contraception because she was having problems with the pill."

One Thai participant appeared to be aware that other couples shared this problem: "Sometimes when women take the pill, they have side effects...and when they complain we get tired of it."

Participating in the clinical trial afforded several discussants the opportunity to observe a change in their partners once they were off the pill. Several men perceived that their partner's libido improved:

"My wife didn't like having sex when she was on the pill. When I was on the 'male pill,' I liked having sex more and she felt comfortable."

"This program has had a lot to do with spontaneity in sex, for me anyway, and for her as well. It really had a big impact. With the pill she was never in the mood anyway, so..."

Other participants were more concerned with the perceived health impact of long-term pill use: "My wife had been on the pill for about 12 years and she was a smoker, in her early 30s, and she was concerned."

"It's not good to take a lot of pills. You get thin and it's no good for the body."

There were also concerns, particularly among Thai men, that their wives forget to take the pill:

"She forgets to take it often. Sometimes she tells me to remind her, but I forget."

Such forgetfulness can lead to mistrust and to fear of pregnancy. For this reason and several others, a number of Thai discussants mentioned that they preferred to take the responsibility for contraception and welcomed the opportunity to have a reversible, effective method that they could control. For a few of these men, freeing their wives from a burden was secondary to preferring to take the initiative themselves:

"The man should do the controlling because women have a lot of problems. If they take the pill, they have problems, then they have to get injections, and they also have side effects. Men don't seem to have as many problems."

"I thought it would be more convenient if we men get the injections. Women sometimes don't have the time while we can spare some time."

Non-Asian men were motivated mainly by their partner's problems, but some also enjoyed a sense of being in control:

"I felt quite neat then because, not only was I furthering the cause of masculine development, but I liked the idea of being in control of my own fertility."

"As far as I was concerned, I was happy, I had control of my own sexuality, my wife was feeling better and easier to deal with. It was a small sacrifice to make, really."

Problems with Other Methods

The men were also very critical of the condom, which was clearly not a method they expected to use in a stable relationship: "Neither of us liked condoms. We tried withdrawal and that's why we have a three-year-old."

As one Scottish participant described the difficulties of negotiating condom use, "Some forms of contraception can also cause relationship problems. You don't like wearing condoms and the wife is insisting--I mean, that can create problems. Whereas this was perfect. Both partners were quite happy with it."

One discussant perhaps overstated the disadvantages of the condom: "Most women are allergic to the condom. They don't like it--it's itchy. There are many problems with the condom."

Australian participants were usually more explicit: "The idea of having sex is that you get to put your bit inside her bit, so you don't want to wrap it up in a bit of rubber...sensuality is really important."

Although focus group participants generally knew of a number of methods they had not tried, some remarks indicated they perceived the lack of alternatives to be greater than it actually is: "The generally consensus with my friends is everybody hates the condom and it seems like the almost automatic alternative is that they'll have to go back to the pill." This participant have ruled out such well-known methods as the diaphragm and the IUD. Both of these methods had negative reputations among respondents that were generally not related to actual experience: Only about 24% of the questionnaire respondents had used a barrier method other than the condom.

Some of the participants expressed the belief that an untried but highly effective contraceptive method was preferable to one that was already known and tried: "We want to have the most effective birth control method. Most of us who came were already using other methods and we came because we thought this was a better way."

And in some cases, side effects interfered with cultural practices, as in the case of a Muslim discussant from Singapore who noted problems with the contraceptive implant: "My wife has gone through many problems with contraceptives. Norplant gave her the most problems. I don't think every woman can take it safely, since it causes hormonal changes. It interferes with our religious practice also. Muslim women cannot perform usual religious rites during menstruation. Sometimes it is difficult to tell whether the bleeding is menstrual or due to Norplant."

A substantial number of discussants mentioned vasectomy as a possibility in the future. Most of the men who did so were young and were concerned about the irreversibility of this decision:

"You see people that have had vasectomies, and they go through the hassle of reversal because relationships break up, and they form a new relationship where there is a desire to have a child."

"I think I have become more open to the option of vasectomy after this trial, seeing that it didn't really change my lifestyle."

Spousal Communication

The men who volunteered to participate in the clinical trials might see themselves as being in more egalitarian, less patriarchal relationships than others. How did the participants, and their partners, decide is on such matters as contraception and participation in the trials? How frequently did they discuss sensitive issues and how comfortable were they in doing so?

The Australians went into considerably more depth in their discussions of gender expectations and decision-making than did the other groups. These discussions revealed a group of reflective men who were struggling with changing gender roles; this change in roles and expectations may further the demand for male methods of fertility regulation. There was a streak of idealism in their comments, as well as a recognition that privilege has its price:

"My wife and I are both independent of each other. It's part of the new way. We are both breadwinners, we both do the work and share everything equally. She tells me what to do and I do my own thing..."

"To a certain extent all those norms, morals and values are raised into prominence because we are precisely in that period of change, so people are forced to think about: Do men have to do things a certain way? What's a typical male?"

Asian men appeared less troubled by gender issues and less questioning of their dominant role than the non-Asian participants:

"I feel that for men who are sole breadwinners, when in the home they should respect their wives. However once outside, I think men should make the final decision."

The Thai men were also more forthcoming about extramarital affairs, and given the sexual freedom of men in Thai society, were more likely to be openly nonmonogamous (participants in the other focus groups did not raise the issue):

Moderator: "When you have other women, do you feel guilty?" Participant: "Only for a short moment." (Laughter).

"Women can lose their honor because if they go running around and people find them and they talk, the gossip soon spreads to the family. For men, it's not a shameful thing, but instead it's an experience in life."

What bearing do these attitudes have on men's use of contraception? Men in different societies may be motivated to use a male method for different reasons. For example, while many participants in the study felt that a method for men was a matter of simple justice, there were cultural differences in the reasoning behind this. Thai participants were more concerned than others about their right to control fertility and with the consequences of not doing so: "If she says she wants to have another child, I might say I don't want her to suffer or have to carry the baby for many months and so on. But in actual fact it's because I don't want to have any. I think it should be the husband" [who makes the decision].

Most of the Thai participants also had completed their families and were concerned about the economic consequences of an unwanted pregnancy: "I have two and that's enough for me. I'm trying not to have any more because we have a fixed amount of income. If we have more, that will be hard on us."

The non-Asian focus group participants were more likely to express guilt about not having taken contraceptive responsibility earlier in their lives: "In years gone past I never gave contraception a second thought. I always had the onus on the woman to provide any contraception, and I thought that was a downer and maybe I should start taking responsibility." These men typically saw their partners as an integral part of the study, whether or not they had made the decision to participate together:

"A joint decision, but I was probably more pro than my wife. She is a bit old-fashioned, as if, you never go into surgery, never try volunteering..."

"It was totally a two-way thing with my partner. We actually read about it when she was having a checkup. We decided to try it. She was involved in it all the way through."

"My wife was so involved she was the one who gave the injections."

As shown in the table, (table omitted) about one-quarter (23%) of respondents to the questionnaire indicated that their spouse's encouragement was the most important reason for joining the study. Several respondents admitted that they had felt pressured by their partners to participate in the clinical trial:

"For me, yes, because my wife experienced a lot of problems when using female contraceptives. As a result, she stopped using it and therefore the responsibility of taking contraception lies with me."

"My wife wanted me to come. At first I was afraid, I wouldn't come. She wanted me to try it so she wouldn't have to take the pill."

The way the participants perceived this pressure was related to their perception of men's gender roles. As one discussant remarked: "What more pressure is there than a woman wanting you to be a man?"

Side Effects

Despite most participants' enthusiasm for the method, a considerable portion of the discussion among focus group participants at each center concerned side effects. In the original 1986-1990 study, 11 men (4%) dropped out because of the pain or frequency of the injections.(7) Although the focus groups revealed a wide variation in the level of discomfort, for some men, the shots were clearly unpleasant:

"I could live without weekly injections. They were fairly uncomfortable....On one or two occasions my arm was dead for two or three days."

"Before the pain is gone from the last injection, you have to get another. This injection doesn't go fast. The fluid is kind of thick so they have to push it slowly."

"Let's face it--you have to be a bit of a loony to get one stuck in your buttock every week."

But most men adapted to the regime and some even surprised themselves in the process:

"I was the sort of person who shied away from needles, ran away from needles, fainted, the lot; then after a couple of weeks it didn't bother me."

"Believe it or not I'm actually adept at giving it to myself in the bum...it's amazing what you'll actually do when you have to."

In addition to the discomfort of injections, the participants were required to provide periodic blood samples and semen specimens every two to four weeks: "I don't think the needles were as bad as the idea of hanging around outside collection rooms waiting for one to become vacant...People know why you are standing there with your little white paper bag."

Moreover, most, but not all, discussants experienced one or more side effects, such as acne, weight gain, increased muscle mass and a small reduction in testicle size:

"I've never been a person with pimples, but I started to get a few across my back, quite monstrous ones. A very painful process to get rid of them."

"I found, too, that I started sweating a lot around the neck. I would wake up and my pillow was wet. I've never had that before. That's the only change I found. I felt better, I think that might be more psychological than anything, because my friends used to say 'have you been in for your man drug?' Perhaps I feel more manly."

"I used to teach sex education and teaching kids testicular self examination, you get to know your balls fairly well, so yes, they became more spongy--a change in consistency as well as volume, but not shriveling up to the size of cashews."

"I actually did enjoy having the eight extra kilos of muscle. It was nice to have extra bulk to bench press, but the pimples were my main problem." (This amount of weight gain was unusual, as participants experienced an average weight gain of less than 4%.(8))

Increased irritability was potentially the most serious side effect mentioned by a few participants; however, ascertaining the true frequency of this type of side effect and establishing its relationship to testosterone injections is problematic, since most participants did not keep diaries and periodic assessments of mood were rare:

"During the study there was only one major episode and it was a doozy. It might have happened anyway. You don't know if it was the testosterone."

"I think if you are in touch with your emotional makeup, it's not hard to see changes. To me it did make a difference, it did aggravate it, but it wasn't insurmountable. I just found that I wasn't prepared for it. It took me a couple of months before I asked myself--what changed? It was the lack of preparation. I had to start taking more physical exercise, taking walks and I had to start counting from one to 10 before I picked up something and threw it."

One participant found that he had less tolerance for stressful situations at work: "It was easy at home. I'm a bartender. With customers [I felt] more confrontational." Furthermore, partners of participants were not interviewed: "I think part of the question you're asking is whether my wife was aware of it [changes in mood] and she never volunteered that she was."

Most focus group participants said they experienced a welcome side effect--a moderate increase in libido (of about 10-20%) during the trial. Even though the diaries kept by trial participants from the United Kingdom revealed no increase in the frequency of sexual intercourse, discussants said they fantasized about sex more frequently and experienced more intense pleasure during intercourse:

"My sex drive certainly changed. It increased and pleasure increased. It was a bonus."

"It definitely increased my sex drive... no question about it. It's tapered off considerably since then. I would say probably in a month, something like that, I started noticing the difference."

One discussant noted that his increased sex drive was not always welcomed by his partner: "She only asked me why it's getting too often." The possibility that freedom from the fear of pregnancy may have also played a role in increased libido cannot be ruled out: "We were less inhibited. When there was no chance of my wife getting pregnant, we could just take that out of our minds and be as natural with each other as possible."

The above quotes suggest that obtaining the partner's perspective on changes in mood and libido is essential to establishing the acceptability of the method. An improved androgen presently under study is expected to reduce, if not eliminate, changes in mood and libido. Addressing these potential side effects is crucial, since many participants entered the trial precisely because their partners were experiencing severe side effects.

The Method's Future

A key question is how well a hormonal method for men would be accepted by the general public. Were these men atypical and thus unlikely to be numerous in the general population? Did they distinguish themselves from others or feel that they were just average citizens? The participants were divided about whether they were "typical" in any sense, with Asian men more likely than non-Asians to feel that they were similar to others. For example, Thai and Singapore men made the following statements:

"I see myself as any other man on the street."

"I think we are more or less the same."

"We shouldn't be a lot different."

Yet in response to the same question on whether they felt different from the typical man, non-Asians offered the following remarks:

"I figure that the people who are doing this program are a different kind of guy anyway, we're not SNAGS [sensitive new-age guys]...I don't think we are typical of white Australian middle class society."

"In general I would say that most men that I'm close to are SNAGS...it would be hard for me to have a friend that is a male chauvinist...I just don't get along with them very well."

"We all know that at this stage of time, it's not socially acceptable for male contraception. We are doing this because we are different."

Did the participants believe that other men would use such a method when it becomes available?

"It depends on how well educated they are. It would take 10 or 20 years really for it to be accepted...it would take a whole social consciousness."

"Well, I think if the injection is really effective, all men will get it because they don't have to worry about getting women pregnant and so on."

"The important thing is the promotion. If the rural people learn about it, if there's good dissemination, they would join."

Of the men who filled out the questionnaire, the majority (65%) indicated they would recommend participation in the clinical trial to others, even with its difficult weekly injection regimen. A much more substantial majority (82%) indicated they would prefer a three-month injectable version of the male hormone, if it were available, to their current method.

Most focus group discussants were also enthusiastic about the method and were disappointed when their friends and colleagues were less so:

"You still get people who would say 'What are you doing that for, can't your wife take the pill or something?' It seems like the abnormal rather than the normal, the idea that the bloke, apart from condoms, would actually take any part of sexual responsibility for contraception, particularly not one which involved needles."

"A lot of guys said it sounded like a really good idea but wouldn't actually commit themselves."

"I told a lot of males about it because...I felt quite proud about the fact that I was on it. I thought it was a great thing to do. Probably out of the maybe 50 guys I told, [another member of the focus group] was the only one who considered it...I thought a lot more people would have said 'that sounds great."

Thai men said they had been envied: "Many of my friends want to come." But they also reported being teased by their colleagues since, as is also true for vasectomy, there was a common misperception that impotence could result. Other Thai men thought that although friends might want to try the method, their wives' negative attitude would present an obstacle: "The men want to come but the women don't want them to. They're afraid they will not have children."

However, U.K. discussants mentioned that women often seemed more receptive to the idea than men:

"Response from other people ranged from disbelief because they didn't know it existed to the women saying to their husbands 'Why don't you get on that?' They all thought it was a good idea."

"Females seem to like it."

"...which is interesting because when you get a program on the tele[vision] and they ask women on the street, they always say they wouldn't trust a man on the pill, but when you really ask them properly, in a stable relationship, they obviously do."

"We found there was more interest in the study amongst our female friends, in fact, quite a few probably would have been interested in [having their partner participate] if they had known about it."

At least among the non-Asian focus group participants, there was an acknowledgment that: "Stable relationships are where it's going to work."

Discussion and Conclusions

The data from these focus group discussions and the post study questionnaire demonstrate the valuable contribution that clinical trial participants can make toward identifying issues that might influence how the general public would accept a new contraceptive method. One such issue is changing gender expectations, which is likely to increase support for a reversible, noncoitus-dependent method for men.

The previous contraceptive problems experienced by many of the clinical trial participants or their partners may not be representative of those experienced by the population at large. The severity of their difficulties may be what distinguishes the participants from other couples, and thus what led them to join the study. The extent of dissatisfaction with current methods needs further exploration, as the issue has myriad implications, including method continuation rates, compliance with a method's protocol and, ultimately, the prospects for new methods.

The frequency of injection was the most common deterrent to the acceptability of the method for the clinical trial participants. Although injections are associated with good health in some Asian cultures, clearly, they were viewed less positively by the Australian, U.K. and U.S. participants. While another mode of delivery might be preferable to some, most participants agreed that a less frequent injection regime would also be acceptable (and some admitted that they were as likely as their wives, if not more so, to forget to take a pill).

Most participants viewed the effects of weight gain and increased muscle mass as advantageous, and were not alarmed by the slight reduction in testicle size. The most significant number of complaints was for acne. There is clearly a need for further exploration of the range and severity of side effects experienced by men using a hormonal method. By the same token, it should not be forgotten that many women continue to use the pill and other methods despite their experience of side effects. Several participants noted that they had had fewer problems with side effects from the male hormone injections than their partners had had with the pill.

The increases in irritability and libido that this particular hormonal regimen can potentially cause will be addressed in future clinical trials by altering the preparation used so that normal hormonal levels will be maintained, rather than temporarily exceeded. Researchers are currently developing methodologies, such as assessing reactions to hypothetical provocation, to identify whether the new formulations of the hormone have successfully dealt with these concerns.

Social and biomedical scientists may view participants' support for a hormonal method for men as particularly encouraging, whether these men are representative of the general population or not. Men from the several countries studied found an injectable to be a more convenient, hassle-free method compared with what they were currently using. The method also offered an answer to their belief in a right to control their own fertility and a solution to the dilemma of sharing contraceptive responsibility with their partners. One participant expressed a view shared by others: "I think it is a very worthwhile investigation. It's not only unfair to make contraception a female responsibility, but it only addresses half of the people involved."

Depending in part on the availability of research funding, a modified or combined version of the product these participants tested could be ready for more wide-scale introductory trials by the year 2000. The present lack of reversible nonbarrier alternatives for men, as well as the problems that the participants' partners had with female methods, counter the assertion that there are already sufficient contraceptive options. For these reasons--the absence of equity and the dissatisfaction with existing female methods--the development of methods to regulate male fertility appears justified and desirable.

References

1. G.M.H. Waites, "Male Fertility Regulation: The Challenges for the Year 2000," British Medical Bulletin, 49:210-221, 1993.

2. World Health Organization (WHO) Task Force on Methods for the Regulation of Male Fertility, "Contraceptive Efficacy of Testosterone-Induced Azoospermia in Normal Men," Lancet, II:955-959, 1990.

3. WHO, Annual Technical Report, Special Programme of Research, Development and Research Training in Human Reproduction, Geneva, 1992; and WHO Task Force on Methods for the Regulation of Male Fertility, "Rates of Testosterone-Induced Suppression to Severe Oligozoospermia or Azoospermia in Multinational Clinical Studies," Fertility and Sterility, forthcoming, 1995.

4. S.A. Matlin, "Prospects for Pharmacological Male Contraception," Drug, 48:851-863, 1994.

5. G.M.H. Waites, 1993, op. cit. (see reference 1).

6. M.E. Khan and L. Manderson, "Focus Groups in Tropical Disease Research," Health Policy and Planning, 7:1-11, 1992; and J. Knodel et al., "Fertility Transition in Thailand: A Qualitative Analysis," Population and Development Review, 10:297-328, 1984.

7. WHO Task Force on Methods for the Regulation of Male Fertility, 1990, op. cit. (see reference 2).

8. WHO Task Force on Methods for the Regulation of Male Fertility, 1995, op. cit. (see reference 3).

Karin Ringheim is a Senior University of Michigan International Population Fellow in the Research Division of the Office of Population, United States Agency for International Development (USAID), Washington, D. C. At the time this report was written, she was a scientist with the Task Force for Social Science Research on Reproductive Health, World Health Organization (WHO), Geneva. This article is based on a report to the Task Force on Methods for the Regulation of Male Fertility of WHO's Special Programme on Research, Development and Research Training in Human Reproduction. Analysis of the data was supported by the Office of Population, USAID. The author would like to thank G.M.H. Waites and David Griffin of WHO, the leaders of the focus groups and the men who participated in the clinical trails.

Copyright The Alan Guttmacher Institute May 1995
Provided by ProQuest Information and Learning Company. All rights Reserved