New Horizons in Male Contraception: Clinical, Cultural and Technological Innovation Aspects

Study question Among health professionals involved in contraceptive prescribing, what are the knowledge, professional attitudes and training on male contraceptive methods? Summary answer The health professionals involved in prescribing contraception are not sufficiently trained in male contraception and almost all of them want more. What is known already The most recent large-scale studies show that 70% of couple contraception is provided by women and that the majority of men and women would be willing to adopt male contraception as couple contraception. The medicalization of contraception places the medical profession at the forefront of the acceptability of and information regarding a contraceptive method. However, only one study have evaluated health professionals’ knowledge of the various methods of male contraception (MC), including male hormonal contraception (MHC) and male thermal contraception (MTC). Study design, size, duration Between April 2020 and June 2020, we carried out a descriptive prospective multicentre study in a medical population of 2243 prescribers of couple contraception in France. Participants/materials, setting, methods The participants were obstetrician-gynaecologists, medical gynaecologists, general practitioners or midwives. They completed a three-part numerical questionnaire, including i) sociodemographic characteristics and personal experiences with contraception, ii) knowledge and professional attitudes about male contraception and iii) training on male contraception. Main results and the role of chance The overall participation rate was 19% (340/2243). Condoms and withdrawal were known by 98% and 89% of the population, respectively. Vasectomy was known by 75% of the population and significantly better known by obstetrician-gynaecologists than by medical gynaecologists and general practitioners (p = 0.026). Male hormonal contraception (MHC) and male thermal contraception (MTC) were known by 10% and 23% of the population, respectively, and were significantly better known by medical gynaecologists and general practitioners than by other specialties (p < 0.001). More than half (55%) of the population never or infrequently offered MC during a couple’s contraceptive request consultation. Female practitioners offered MC significantly more often than male practitioners (48% vs. 26%; p = 0.033). Only 14% of the population had ever participated in training on MC, 96% wished to be better trained on MC, and 86% expressed a willingness to participate in such a training. Limitations, reasons for caution The population was mainly representative of medical health practitioners of southeastern France. There was an over-representation of women in all medical specialties, except for midwives. Wider implications of the findings: Our study shows that health professionals involved in contraception have limited knowledge about MC and are eager to have more information about it. To advance the acceptability and dissemination of such contraceptive methods, it seems imperative to provide health professionals with an adapted training program on male contraception. Trial registration number 2020–01–23–03

Most existing studies on men's willingness to use novel hormonal male contraceptives (HMCs) rely on survey data and focus on the hypothetical use of HMCs. The aim of this in-depth, qualitative study was to elicit the perspectives of HMC clinical trial participants - men who have actually used an HMC - to describe their motivations for using HMCs. In 2017-18 we conducted 30 in-depth, semi-structured interviews with a sample of men who participated in early-stage HMC clinical trials in Los Angeles or Seattle to explore their experiences with and motivations for trialing a HMC. Using thematic analysis, we analyzed deidentified transcripts using deductive and inductive codes, summarizing key themes using a socioecological framework. Participants averaged 35 years old (range: 22-52) and were ethnically and sociodemographically diverse. Men's motivations for using an HMC centered on societal-level factors (i.e., concerns regarding 'overpopulation' and responsible childbearing), partnership factors (concerns regarding entrapment; desire to share in contraceptive responsibility), and individual-level factors (i.e., contraceptive options that maximized pleasure and intimacy; beliefs in men's contraceptive and bodily autonomy). This study provides the first U.S.-based, in-depth qualitative insights from men who have used HMCs. Men's motivations for participating in HMC clinical trials and wanting to use novel male contraceptives are both numerous and multi-faceted, supporting prevailing survey data on men's willingness to use them once on the market. These data offer insights on how male contraceptives could be marketed to the general public. Men's motivations vary with respect to participation in hormonal male clinical trials and desire to use HMCs when they become available. All of these motivations - from the broader, societal level, to the individual and partnership level - are critical to assessing the demand for and subsequent marketing of HMCs.

<b>Background: </b>Male<b> </b>contraceptive options are limited to condoms or vasectomy and have lacked significant developments for about a century, suggesting the value of exploring male hormonal contraceptives (MHC). In October 2018, a transdermal gel method entered Phase 2 clinical trials, indicating MHC may soon be available. However, eventual uptake of potentially contentious innovations, like MHC, requires informed marketing and promotional strategy. Consumer behavior research methodologies can aid in determining consumer perspectives, providing a framework for effective marketing to encourage MHC adoption upon market introduction. <b>Methods: <i>Phases 1 &amp; 2.</i> </b>Focus groups (n=29) and individual, in-depth interviews (n=20) among college-aged men and women aged 18-26 years were conducted using a semi-structured approach. Techniques from expanded grounded theory were used, allowing for a constant comparative approach to data contextualization and theme identification. Ads were created based on focus group results and tested in the interviews. Content analysis served as the data analysis strategy, allowing for a constant comparative approach to data contextualization and theme identification. <b><i>Phase 3.</i></b> College-aged men and women (n=1,997) aged 18-26 years participated in a web-based survey. Multiple linear regression was used to examine significant predictors of attitudes toward, interest in, and intention to use or encourage use of MHC. A conjoint analysis procedure was also used to assess the relative importance of attributes on ad effectiveness and preference. <b>Results: <i>Phase 1.</i> </b>Three primary themes emerged from focus group discussions: 1) openness to MHC; 2) resistance to MHC; and 3) MHC gel innovation characteristics. Men and women were generally interested in the idea of an MHC method. Hesitance about MHC surrounded the social acceptance of a novel contraceptive product, resistance to changing current contraceptive routines, and fear of health consequences. Participants shared insights about promotional strategies which fell within the diffusion of innovations (DOI) characteristics of relative advantage, complexity, compatibility, and observability. <b><i>Phase 2.</i></b> In-depth interviews offered insight into perceptions of message development for MHC. Four themes emerged: 1) humor, 2) information, 3) relatability, and 4) credibility. Message testing in interviews yielded an understanding of elements participants responded most strongly to, including: 1) ad sentiment, 2) trustworthiness, and 3) visual appeal. <b><i>Phase 3.</i></b> Regression analyses revealed being sexually active (p=0.001) and having prior knowledge of potential MHC methods (p=0.031) aligned with positive MHC attitudes, interest, and intention. Conservative political views (p=0.002) and being satisfied with current male birth control offerings (p=0.000) were associated with negative MHC attitudes. Conjoint analysis identified informational messages as most important (56.62%). Informational (p=0.000) and aspirational messages (p=0.003) paired with relatable characters were the most highly preferred ads.<b> </b><b>Conclusions: </b>Findings revealed college-aged men and women express a general interest in the idea of MHC, with hesitance stemming from social acceptance of a novel contraceptive product, resistance to changing current contraceptive routines, and fear of potential side effects and long-term health consequences. Promotional strategy for MHC, or similar novel health products, must focus on stratifying consumers based on their readiness to accept a potential innovation and use tactics like aspirational marketing, social norms marketing, and informational marketing to confirm benefits and address concerns. Qualitative formative research also illuminated salient concepts for MHC advertising. Message testing revealed informational ads with elements of credibility may be most useful for promoting MHC, along with ad concepts audiences feel they can relate to or trust, and practical messaging or imagery meant to increase agency in use. The quantitative survey further supported these findings among a broader, university audience, indicating informational messages or aspirational messages paired with trustworthy, relatable characters are the most effective ad attributes to incorporate into marketing strategy when promoting a novel contraceptive product, like MHC.<b></b>

Development of a transdermal gel for reversible male contraception.

Some women are unable to use currently available female contraceptives due to health conditions or side effects, leaving some couples without effective contraceptive options. In addition, many men wish to take active responsibility for family planning. Thus, there is a great need for male contraceptives to prevent unintended pregnancy, of which 80–90 million occur annually. At present, effective male contraceptive options are condoms and vasectomy, which are not ideal for all men. Therefore, efforts are under way to develop novel male contraceptives. This paper will briefly review the advantages and disadvantages of condoms and vasectomies and then discuss the research directed toward the development of novel methods of male contraception.

Despite the variety of available female contraceptive methods, many pregnancies (&#126;50%) are still undesired. Many men (&#62;60%) want to participate equally with their partner in family planning; however, male contraceptive methods (MCMs) account for only 14% of those used worldwide and no pharmaceutical MCM is available so far. The only two MCMs currently available are condoms, which despite protecting against sexually transmitted diseases have high failure rates (&#126;19%), and vasectomy, which though very efficient (99%) is poorly reversible (&#60;50%). Among MCMs under investigation, male hormonal contraceptives (MHCs) are those that have come closest to commercialization. The action of MHCs relies on the disruption of spermatogenesis that exogenous androgen administration evokes by suppressing the hypophyseal-gonadal axis. Various regimens of androgens as monotherapy or in combination with progestins have been tested in clinical trials achieving a Pearl Index &#60;1.0 (equal to that of the female oral contraceptive pill); however, concerns regarding the variable response rates observed (non-responders: 5-20%), the impracticality of parenteral administration and long-term prostate-associated or cardiovascular morbidity have deflected the interest of the pharmaceutical industry from further research. Non-hormonal contraception methods may be, at least theoretically, more specific by selectively disrupting spermatogenesis and sperm transport or fertilizing ability. Nevertheless, only a few have been tested in clinical trials (Reversible Inhibition of Sperm Under Guidance, RISUG, and Intra Vas Plugs); most of them are still in pre-clinical development or have been abandoned due to toxicity (gossypol). Consequently, until a reliable, safe and practical MCM is developed, women will continue to bear most of the contraception burden.

The present study aims to determine the Turkish men’s knowledge level on family planning and contraceptive methods, contraception preferences, and their attitudes towards male contraceptive pills, which is not one of the contraceptive methods used in our country, among 18+-year-old men, who applied to family health center polyclinic. In this prospective study, a questionnaire consisting of 19 questions was conducted to 527 men over the age of 18. It was observed that 86.3% of the participants (53.8% of men, 32.8% of women and 13.4% of both genders) used contraceptive methods. The most commonly used contraceptive methods among men are as follows; condoms (57.8%), coitus interruptus (40.4%) and other methods (1.8%). Among the reasons for not wanting to use; the rate of side effects was 53.7%, the ease and success rate of other methods was 16.2%, the difficulty of use was 13.6%, and the rate of other reasons was 16.5%. There was a statistically significant relationship between educational status, use of the contraceptive method, and status of knowing that there is a male contraceptive pill (p=0.0001, p=0.0001). Male contraceptive pills can be an important option in family planning if Turkish men, who are concerned about the side effects of the contraceptive pill, are provided with the necessary information, and also have easy access to male contraceptive pills.

Obwohl effektive Verhütungsmethoden in Deutschland und anderen Industrienationen verfügbar sind, ist die Schwangerschaftsrate bei Teenagern weiterhin hoch. Ursächlich hierfür sind neben anderen Gründen insbesondere die Anwendung ineffektiver Methoden bzw. die fehlende Anwendung auch nur irgendeiner Verhütungsmethode. Existierende männliche Kontrazeptionsmethoden weisen entweder eine unbefriedigende Effektivität (Kondom, Koitus interruptus) auf oder sind nur bedingt reversibel (Vasektomie), was einer weiteren Verbreitung im Wege steht. Von den experimentellen Verhütungsmethoden beim Mann erscheint die hormonelle Kontrazeption zurzeit am weitesten entwickelt. Androgene sind elementarer Bestandteil der hormonellen Kontrazeptiva, da sie über eine Suppression der Gonadotropine zu einer Suppression der Spermatogenese führen und gleichzeitig den durch die Gonadotopinsuppression bedingten Androgenmangel ausgleichen. Wenn auch die Wirksamkeit einer hormonellen Methode bei Männern in klinischen Studien gezeigt werden konnte, so scheiterte die weitere Entwicklung zunächst an dem unpraktikablen Applikationsintervall bzw. an der mangelnden Effektivität der selbst anwendbaren Ansätze. Neuere effektive Ansätze in Phase II Studien konzentrieren sich daher auf die Verwendung von Androgen-Implantaten bzw. langwirksamen Testosterondepotinjektionen in Kombination mit den Gestagenen-Depots Medroxyprogesteron Azetat, Norethisteron, Desogestrel oder Etonogestrel, die zusätzlich zu den Androgenen die Gonadotropine supprimieren. Ob die hormonelle Kontrazeption beim Mann auch eine Alternative für Jugendliche darstellt bleibt nach der Markteinführung abzuwarten. Bedenken ergeben sich insbesondere hinsicht lich der Knochenreifung, da Androgene in den verwendeten Dosen einen vorzeitigen Schluss der Epiphysenfugen bewirken könnten.

BackgroundSince the release of the combined oral contraceptive pill in 1960, women have shouldered the burden of contraception and family planning. Over 60 years later, this is still the case as the only practical, effective contraceptive options available to men are condoms and vasectomy. However, there are now a variety of promising hormonal and non-hormonal male contraceptive options being studied. The purpose of this narrative review is to provide clinicians and laypeople with focused, up-to-date descriptions of novel strategies and targets for male contraception. We include a cautiously optimistic discussion of benefits and potential drawbacks, highlighting several methods in preclinical and clinical stages of development.ResultsAs of June 2023, two hormonal male contraceptive methods are undergoing phase II clinical trials for safety and efficacy. A large-scale, international phase IIb trial investigating efficacy of transdermal segesterone acetate (Nestorone) plus testosterone gel has enrolled over 460 couples with completion estimated for late 2024. A second hormonal method, dimethandrolone undecanoate, is in two clinical trials focusing on safety, pharmacodynamics, suppression of spermatogenesis and hormones; the first of these two is estimated for completion in December 2024. There are also several non-hormonal methods with strong potential in preclinical stages of development.ConclusionsThere exist several hurdles to novel male contraception. Therapeutic development takes decades of time, meticulous work, and financial investment, but with so many strong candidates it is our hope that there will soon be several safe, effective, and reversible contraceptive options available to male patients.

Canadian Contraception Consensus (Part 2 of 4).

Canadian Contraception Consensus (Part 1 of 4).

It is time for new male contraceptives!

During the second half of the 20th century, progress in developing novel, practical contraceptive methods for men has lagged significantly behind developments for women. Despite the lack of reliable, reversible methods, men throughout the world continue to be strongly involved in family planning but a greater involvement will require more attractive and reliable contraceptive options for men. The closest to fruition are hormonal methods the features of which are reviewed. Landmark WHO contraceptive efficacy studies have established that hormonally-induced azoospermia provides highly effective and reversible contraception for at least 12 months with minimal short-term side effects. Even among the small subgroup of men who remain oligozoospermic during hormonal suppression, good contraceptive efficacy is achieved. The present goals are to develop improved second generation hormonal regimens which provide more uniform azoospermia to obviate the need for monitoring of sperm output and to develop long-acting depot testosterone formulations used alone or with additional gonadotrophin suppressive agents such as progestins or GnRH antagonists. Significant obstacles to progress are the flight of industry from contraceptive R&D dur to the financial deterrent posed by the product liability crisis as well as the low priority accorded male reproductive health. Together those will determine whether the range of contraceptive options available to our children in the 21st century will improve, or whether the historically recent unbalanced increase in reliance on women for family planning will continue.

Design of an international male contraceptive efficacy trial using a self-administered daily transdermal gel containing testosterone and segesterone acetate (Nestorone)

Two male contraceptive methods that inhibit spermatogenesis currently exist: thermal male contraception and hormonal male contraception.Only five studies have been conducted on the acceptability of these methods among men; among women, only the hypothetical acceptability of such a male contraceptive approach as the sole contraception method used by a couple has been evaluated. To evaluate the motivation, experience, and satisfaction of female partners in couples using hormonal male contraception or thermal male contraception as the sole contraception. In this cross-sectional study, 123maleusers of hormonal male contraception or thermal male contraception as the couple's sole contraception method were asked to invite their female partner to participate in an anonymous online survey. The questionnaire included 95 questions exploring population characteristics, contraceptive and pregnancy history, motivations for choosing hormonal male contraception or thermal male contraception, the experience of the women in the successive phase of use, relationships with theirpartner, and satisfaction with the contraception method. The response rate among participating women was 69% (59/86). The two main reasons for choosing male contraceptive were the desire to sharethecontraception role in the couple (65%) and the desire of the man to take charge of the contraception (61%). The sexual satisfaction score increased significantly between the contraceptive methods used before hormonal male contraception or thermal male contraception and the phase of contraceptive use (p<0.01). The overall satisfaction level with thermal male contraception or hormonal male contraception was rated at 3.7±0.6 out of 4. Women mostly recommended hormonal male contraception or thermal male contraception because of the share of contraceptive responsibility and mental load (n=23/54, 43%). This population of women seemed to have struggled to find a contraceptive method that suited them, but most took advantage of thermal male contraception or hormonal male contraception and trusted their male partner to take charge of contraception use. The positive evaluation from women in partnerships using thermal male contraception and hormonal male contraception should encourage the development of these methods.