Male contraceptive

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Male contraceptives, also known as male birth control, are methods of preventing pregnancy that are used by males or people who produce sperm.[1] The main forms of male contraceptives available today are condoms, vasectomy, and withdrawal, and these methods combined make up less than one-third of global contraceptive use.[2][3][4][5]

New forms of male contraception are in clinical and preclinical stages of research and development, but as of 2024, none have reached regulatory approval for widespread use.[6][7][8][9] These new methods include topical creams, daily pills, injections, long-acting implants, and external devices, and these products have both hormonal and non-hormonal mechanisms of action.[6][10][11][12][13][14][15] Although this article will use the term "male" for clarity, these contraceptives are best described as "sperm-targeting", since they would be effective in any person that produces sperm, regardless of that person's gender identity. Some of these new contraceptives could even be unisex, or usable by any person, because they deactivate mature sperm either in sperm-producing bodies before ejaculation or in egg-producing bodies after sperm arrives.[16][17]

Surveys indicate that around half of men in countries across the world are interested in using a variety of novel contraceptive methods,[18][19][20][21] and men in clinical trials for male contraceptives have reported high levels of satisfaction with the products.[12][22] Women worldwide have also shown a high level of interest in new male contraceptives, and though both male and female partners could use their own contraceptives simultaneously, women in long-term relationships have indicated a high degree of trust in their male partner's ability to successfully manage contraceptive use.[18][23][24]

Modelling studies suggest that even partial adoption of new male contraceptives would significantly reduce unintended pregnancy rates around the globe,[25] which remain at nearly 50%, even in developed countries where women have access to modern contraceptives.[26][27][28] Unintended pregnancies are associated with negative socioeconomic, educational, and health outcomes for women, men, and the resulting children (especially in historically marginalized communities),[27][29][30][31][32][33][34] and 60% of unintended pregnancies end in abortions,[35][36] many of which are unsafe and can lead to women's harm or death.[37][38][39][40] Therefore, the development of new male contraceptives has the potential to improve racial, economic, and gender equality across the world, advance reproductive justice and reproductive autonomy for all people, and save lives.

Currently available methods[edit]

Vasectomy[edit]

Diagram of an open vasectomy

Vasectomy is surgical procedure for permanent male sterilization usually performed in a physician's office in an outpatient procedure.[41] During the procedure, the vasa deferentia of a patient are severed, and then tied or sealed to prevent sperm from being released during ejaculation.[42] Vasectomy is an effective procedure, with less than 0.15% of partners becoming pregnant within the first 12 months after the procedure.[43] Vasectomy is also a widely reliable and safe method of contraception, and complications are both rare and minor.[44][45] Vasectomies can be reversed, though rates of successful reversal decline as the time since vasectomy increases, and the procedure is technically diffficult and often costly.[42][46][41]

Condoms[edit]

A rolled-up condom

A condom is a barrier device made of latex or thin plastic film that is rolled onto an erect penis before intercourse and retains ejaculated semen, thereby preventing pregnancy.[47] Condoms are less effective at preventing pregnancy than vasectomy or modern methods of female contraception, with a real-world failure rate of 13%.[43] However, condoms have the advantage of providing protection against some sexually transmitted infections such as HIV/AIDS.[48][49] Condoms may be combined with other forms of contraception (such as spermicide) for greater protection.[50]

Withdrawal[edit]

The withdrawal method, also known as coitus interruptus or pulling out, is a behavior that involves halting penile-vaginal intercourse to remove the penis out and away from the vagina prior to ejaculation.[51][52] Withdrawal is considered a less-effective contraceptive method, with typical-use failure rates around 20%.[41][43] However, it requires no equipment or medical procedures.[51]

Contraceptive Failure Rate[43][note 1]
Method Typical use Perfect use
Vasectomy 0.15% 0.10%
Condoms 13% 2%
Withdrawal 20% 4%

Research into new methods[edit]

Researchers are currently working to generate novel male contraceptives with diverse mechanisms of action and possible delivery methods, including long-acting reversible contraceptives (LARCs), daily transdermal gels, daily and on-demand oral pills, monthly injectables, and implants.[53][54][55] Efforts to develop male contraceptives have been ongoing for many decades, but progress has been slowed by a lack of funding and industry involvement. As of 2024, most funding for male contraceptive research is derived from government or philanthropic sources.[56][57][58][59]

Novel male contraceptives could work by blocking various steps of the sperm development process, blocking sperm release, or interfering with any of the sperm functions necessary to reach and fertilize an egg in the female reproductive tract.[60] Advantages and disadvantages of each of these approaches will be discussed below, along with relevant examples of products in development.

Methods that block or interfere with sperm production[edit]

These methods work by preventing the testes from producing sperm, or interfering with sperm production in a way that leads to the production of nonfunctional sperm.[61] This approach can be accomplished by either hormonal or nonhormonal small-molecule drugs, or potentially by thermal methods. The effectiveness of contraceptives in this group can be easily assessed microscopically, by measuring sperm count or abnormalities in sperm shape, but because spermatogenesis takes approximately 70 days to complete,[62] these methods are likely to require approximately three months of use before they become effective, and approaches that halt sperm production at an early stage of the process may result in reduced testicular size.[63][64]

Hormonal male contraceptives[edit]

Hormonal contraceptives for men work similarly to hormonal female methods, using steroids to interrupt the hypothalamic-pituitary-gonadal axis and thereby block sperm production. Administering external androgens and progestogens suppresses secretion of the gonadotropins LH and FSH, which impairs testosterone production and sperm generation in the testes, leading to reduced sperm counts in ejaculates within 4–12 weeks of use.[65] However, since the contraceptives contain testosterone or related androgens, the levels of androgens in the blood remain relatively constant, thereby limiting side effects and maintaining masculine secondary sex characteristics like muscle mass and hair growth.[65]

Multiple methods of male hormonal contraception have been tested in clinical trials, and although one trial was halted early, leading to a large amount of press attention,[66][67][68][69][70] most hormonal male contraceptives have been found to be effective, reversible, and well-tolerated.[71][72][73][74][75][76]

In clinical trials[edit]

As of 2024, the following hormonal male contraceptive products are in clinical trials:

  • NES/T (Nesterone/Testosterone gel) is a transdermal gel that users apply to the upper arms and shoulders once daily.[77][78] Developed as a collaboration between the NICHD and Population Council, NES/T is in a phase II clinical trial,[79] where it is being evaluated for safety and efficacy, with healthy couples relying on it as their only means of birth control.[10][80][81][82]
  • DMAU (Dimethandrolone undecanoate) is a steroid-based contraceptive molecule with both androgenic and progestational activities, which allows it to be used as a single agent. DMAU has been tested in clinical trials in both oral[83][22] and injectable forms.[11]
  • 11β-MNTDC is another dual-function molecule (progestogenic androgen) in clinical development as an oral contraceptive for men.[12]

Some anabolic steroids may exhibit suppressive effects on spermatogenesis, but none are being investigated for use as a male contraceptive.[84]

Non-hormonal male contraceptives[edit]

Non-hormonal contraceptives for men are a diverse group of molecules that act by inhibiting any of the many proteins involved in sperm production, release, or function. Because sperm cells are highly specialized, they express many proteins that are rare in the rest of the human body.[85][86][87] This suggests the possibility that non-hormonal contraceptives that specifically block these sperm proteins could have fewer side effects than hormonal contraceptives, since sex steroid receptors are found in tissues throughout the body.[88] Non-hormonal contraceptives can work by blocking spermatogenesis, sperm release, or mature sperm function, resulting in products with a wide variety of usage patterns, from slow onset to on-demand usage.[89] Contraceptives targeting mature sperm functions could even be taken by both sperm-producing and egg producing people.[17][16] Challenges of non-hormonal contraceptive development include bioavailability and delivery past the blood-testis barrier.[90]

In clinical trials[edit]

As of 2024, the following non-hormonal male contraceptive product is in clinical trials:

  • YCT529, a retinoic acid receptor antagonist, began a Phase 1 clinical trial in 2023[91] organized by the US startup YourChoice Pharmaceuticals.[92][93][94] It has been known since the late 1950s that blocking the retinoic acid/Vitamin A signalling pathway inhibits spermatogenesis in rodents and humans, and various attempts have been made to develop male contraceptives that use this approach.[95][96][97] Development success of these earlier molecules has been limited by off-target effects.[98]
In preclinical development[edit]

As of 2024, the following non-hormonal male contraceptive products are in preclinical development:

Thermal male contraception[edit]

Prolonged testicular heating has been shown to reduce sperm counts,[110][111][112] but no modern clinical trials have demonstrated the safety, contraceptive effectiveness, or reversibility of this approach. Various devices are in early preclinical stages of development, and some approaches are being used by men through self-experimentation.[14][113] The mechanism by which heating disrupts spermatogenesis is still not fully understood,[114] and there are concerns that prolonged heating could increase the risk of testicular cancer (since natural cryptorchidism carries a high risk of testicular cancer[115]) or that heating could damage sperm DNA, resulting in harm to potential offspring.[116]

Methods that block sperm release[edit]

These approaches work by either physically or pharmaceutically preventing the emission of sperm during ejaculation, and are likely to be effective on-demand.

Vas-occlusive contraception[edit]

Vas-occlusive contraception provides a contraceptive effect through physical blockage of the vas deferens, the duct connecting the epididymis to the urethra. While a vasectomy excises, or removes, a piece of each vas deferens and occludes the remaining open ends of the duct, vas-occlusive methods aim to block the duct while leaving it intact. Vas-occlusive methods generally aim to create long-acting reversible options, through a second procedure that removes the blockage.[117] However, full reversibility remains questionable, since animal and human studies have shown sperm abnormalities, incomplete recovery of sperm parameters, and the development of fertility-impairing antibodies against one's own sperm after blockage removal.[98][118][119][120][121][122]

In clinical trials[edit]

As of 2024, the following vas-occlusive male contraceptive product is in clinical trials:

  • ADAM is a hydrogel-based male contraceptive implant in early clinical development[123] by Contraline, Inc.[124] The implant is administered to a user in a procedure similar to a no-scalpel vasectomy, and is proposed to provide protection from pregnancy for approximately two years, after which the hydrogel degrades, thereby restoring fertility.[125]
In preclinical development[edit]

As of 2024, the following vas-occlusive male contraceptive products are in preclinical development:

  • RISUG is an injectable male contraceptive implant that has been in development in India since the 1970s,[126][127] which is proposed to be reversed through a second injection that dissolves the polymer, though reversibility has not yet been demonstrated in humans.[128] Plan A, formerly known as Vasalgel, is an adaptation of the polymer used in RISUG in development in the United States.[129][130][131][132][133][134][135]
  • Other methods for vas occlusion have been proposed, though these methods are largely in very early development.[136][137][138][139]

Barrier methods[edit]

Research into new, more acceptable designs of condoms is ongoing.[140][141]

Methods that block functions of mature sperm[edit]

These approaches work by blocking functions that mature sperm need in order to reach and fertilize an egg in the female reproductive tract, such as motility, capacitation, semen liquification, or fertilization. Drugs or devices that target mature sperm are likely to be effective on-demand (taken just before intercourse), and could even be delivered either in sperm-producing or egg-producing bodies, leading to unisex contraceptives.[17][16]

In preclinical development[edit]

As of 2024, the following non-hormonal male contraceptive approaches are in preclinical or early development:

Acceptability[edit]

Although some people question whether men would be interested in managing their own contraceptives[164] or whether women would trust their male partners to do so successfully,[165] studies consistently show that men around the world have significant levels of interest in novel forms of male contraception[18][23][166][19][167][168] and that women in committed relationships would generally trust their male partners to manage the contraceptive burden in the relationship.[23] Additionally, males participating in various contraceptive clinical trials have reported high satisfaction with the products they were using.[81][12][22]

Among men[edit]

Studies on potential uptake indicate that in most countries, more than half of men surveyed would be willing to use a new method of male contraception.[18][20][166][169][170][171] Interestingly, some of the highest rates were reported in low-income countries like Nigeria and Bangladesh where 76% of men surveyed indicated that they would be willing to use a new method within the first 12 months that it is available.[18] This is particularly compelling, since it has been estimated that a mere 10% uptake of new male contraceptive methods could avert nearly 40% of unintended pregnancies in Nigeria.[25] Across the world, many young and middle-aged men especially want the ability to control their own fertility, and are not well-served by existing family planning programs.[172]

Although a phase II trial for an injectable male contraceptive was halted in 2011 by an independent data safety monitoring board due likely to rare adverse effects experienced by some participants,[173][67] leading many popular articles to suggest men could not tolerate side effects similar to those that many women endure on hormonal birth control,[174][175] in reality more than 80% of the study's male participants stated at the end of the trial that they were satisfied with the contraceptive injection, and would be willing to use the method if it were available.[176] Subsequent hormonal male contraceptive clinical trials have progressed successfully, showing high levels of efficacy and acceptability among the participants.[12][22][81][177]

Among women[edit]

It is sometimes assumed that women won’t trust men to take contraceptives, since women would bear the consequences of a male partner's missed dose or misuse.[165] Of course, male contraceptive options would not have to replace female contraceptives, and in casual sexual encounters both partners may prefer to independently control their own contraceptive methods. On the other hand, some long-term couples might want only one partner to bear the contraceptive burden. Indeed, there is evidence that a large proportion of women in relationships in many countries around the world would trust their partners to take a potential male method,[24][18] and many women want more male partner involvement in their own reproductive health services.[178] Further, current contraceptive use data show that more than a quarter of women worldwide already rely on male-controlled methods for contraception (such as condoms and vasectomy),[179] and this figure could grow as more male contraceptive methods become available.

Potential benefits[edit]

On unintended pregnancy rates[edit]

Despite the fact that modern female pharmaceutical contraception has been on the market since the 1960s,[180] 40-50% of pregnancies are still unintended worldwide, leading to an approximate total of 121 million unintended pregnancies annually.[181][182][183] Importantly, most studies on unintended pregnancies only measure the female partner's intentions about the pregnancy, and so pregnancies that were unintended by male or sperm-producing partners are understudied and may be under-reported.[184] Unintended pregnancies have been shown to be linked with a wide variety of negative outcomes on mental and physical health, as well as educational and socioeconomic attainment in both parents and the children born of unintended pregnancies.[27][29][30][32][33][34]

Surprisingly, although the rate of unintended pregnancies (per 1000 women of childbearing age) is higher in developing countries,[182][185][186] the percentage of pregnancies that are unintended is actually higher in developed countries, since a lower proportion of women in developed countries are intending to conceive at any given time.[182] Research indicates that unmet need for modern contraception is the cause of 84% of unintended pregnancies in developing countries.[187] In the United States, which has a higher unintended pregnancy rate than many other developed nations,[188] one important reason that women cite for nonuse of contraceptives is concerns about the side effects of existing products.[189] Taken together, these statistics suggests that the current suite of contraceptives is insufficient to meet the fertility planning needs of people across the world, and therefore the introduction of new male contraceptives is likely to decrease the stubbornly high global rates of unintended pregnancy.[25] Indeed, modeling shows that approximately 5% of unintended pregnancies in the USA and 30-38% of unintended pregnancies in Nigeria could be prevented with male contraception uptake of only 10% in those countries,[25] which is a very low estimate of male uptake, according to newer acceptability research in these countries.[18] In absolute terms, this modelling suggests that novel male contraceptives could avert roughly 200,000 unintended pregnancies per year in both the USA and Nigeria.[25]

For men[edit]

Fathers with unintended births report lower proportions of happiness than in fathers with intentional births[190] and unintended fatherhood for men in their early 30's is associated with a significant increase in depressive symptoms.[191] In addition, men in insecure financial situations are more likely to report a recent unintended pregnancy,[184] and supporting and raising a child brings significant costs that can exacerbate financial insecurity.[192][193] More broadly, access to effective and reliable contraception would advance men's ability to "maintain personal bodily autonomy, have children, not have children, and parent the children we have in safe and sustainable communities" in accordance with the principles of Reproductive Justice.[194]

For women and gender equity[edit]

Family planning has been found to be associated with overall well-being and is one of the most efficient tools for women's empowerment.[195][196][197] Positive outcomes of effective birth control include improvements in women's health, self-agency, education, labor force participation, financial stability, as well as decreases in pregnancy-related deaths,[198][199][200] and these positive social and health impacts may be further realized by the addition of novel male and unisex methods.[25][18] New male contraceptive options would not come at the expense of women’s reproductive autonomy, since women would still be able to take advantage of all of the contraceptive methods available to them, choose to have both partners use their own contraceptive methods at the same time, or rely solely on their male partners’ form of contraception.

Interventions encouraging male engagement in couples' reproductive health and decisionmaking have shown positive outcomes related to promoting more equitable gender norms in the context of family planning,[201] and increased joint decision making in couples. It is reasonable to assume from these data that increasing male involvement as contraceptive users will further improve gender equity.[202]

For transgender, nonbinary, and intersex people[edit]

While this article has used the term "male" contraception for clarity, these contraceptives are most accurately described as "sperm-targeting" contraceptives, since they would work effectively in any body that produces sperm, regardless of that person's gender identity or external genitalia.[17] Importantly, contraceptives that block functions of mature sperm could be delivered in a unisex manner, incapacitating sperm before ejaculation in sperm-producing people, or after sperm arrives in the body of egg-producing people.[16][17]

Transgender, nonbinary, and intersex people are underserved by current contraceptive options. For example, many trans men can become pregnant (both intentionally and unintentionally),[203] but may prefer not to use estrogen- or progestin-containing hormonal birth control (both because of the social classification of these hormones as "female sex hormones" and because of a fear they will interfere with masculinizing hormone therapy, although the American College of Obstetricians and Gynecologists states that these hormonal contraceptives have little effect on masculinization.)[204][205][206] Trans women who have not had gender-affirming genital surgery may have similar unmet contraceptive needs as those of cisgender men, since gender-affirming hormonal therapy is not effective contraception.[206] Nonbinary and intersex people may be less likely to use current methods of birth control, since they are popularly categorized by the labels "male" and "female", which may not match an individual's gender identity or may invoke feelings of gender dysphoria.[205] This dynamic may contribute to the higher rates of unintended pregnancies seen in the LGBTQ+ community as compared to heterosexual peers,[207][208][209] which could in theory be ameliorated by the introduction of unisex contraceptives.

For child welfare[edit]

Novel male contraceptive options are predicted to reduce the incidence unintended pregnancies,[25][18] and being the product of an intended rather than unintended pregnancy has been shown to correlate with improved health and wellbeing outcomes in children.[31][199][210][211] Additionally, reduced family size correlates with improved educational outcomes,[212] and children born after the introduction of family planning programs in the USA experienced a reduction in poverty rates, both in childhood and adulthood.[213]

For racial and socioeconomic equality[edit]

Unintended pregnancies rates increase as income decreases, both between countries[36] and between socioeconomic and racial groups within a given country.[188][214]  Women of color, especially Black women, in the United States and other developed countries have dramatically higher rates of death during and after birth and worse maternal health outcomes, due in part to systemic discrimination.[215][199]  Since unintended pregnancies can have negative effects on an individual's physical and mental health, educational attainment, and economic prospects, these higher unintended pregnancy rates likely contribute to the persistent socioeconomic gaps within and between societies.[27][29][30][31][32][33][34]   It’s therefore possible that the introduction of new male contraceptives would not only mitigate gender inequities, as discussed above, but racial and income inequities as well, by providing more ways for individuals to avoid unintended pregnancies.[25]

For national economies[edit]

In addition to the personal financial savings of avoiding unintended pregnancy mentioned above, on a societal level, contraceptives are a public health intervention with a high return on investment: for every dollar the United States government spends on family planning programs, it saves $7.09, for a total of over $13 billion per year.[216] Unintended pregnancies in the United States are estimated to cause $4.5 billion in direct medical costs.[34][32] New male contraceptives are likely to prevent some unintended pregnancies[25] and therefore reduce these costs.

On abortion rates[edit]

61% of unintended pregnancies end in abortion,[35] whereas only 20% of all pregnancies end in abortion.[217] Interestingly, unintended pregnancy rates are higher in countries where abortion is illegal than those where abortion is legal, yet the incidence of abortion is similar between these groups of countries.[35][218] Illegal abortions are more likely to be unsafe, and there are an estimated 25 million unsafe abortions globally each year, leading to 50,000 - 70,000 yearly deaths and 5 million people with long-term health consequences.[37][38][39][40] Importantly, increases in the prevalence and uptake of modern contraceptives have been shown to decrease unintended pregnancy and abortion rates when fertility rates are constant.[219][220][221] This suggests that the introduction of new forms of male contraception could prevent a significant number of abortions, save lives, and avoid unnecessary suffering.

History[edit]

A variety of plant extracts have been used throughout history in attempts to prevent pregnancy, though most were used by women, and the efficacy and safety of these methods is questionable.[222][223][224] Condoms have been in documented use since at least the 16th century.[225]

Past research efforts[edit]

Many researchers have attempted to develop male contraceptive products over the last hundred years. A selection of these efforts (that are no longer in development as of 2024) are listed below.

  • Hormonal
  • Non-Hormonal
    • Gossypol, an extract of cotton, has been studied as a male contraceptive pill. It decreased sperm production, but this effect was permanent in 20% of people.[227][228]
    • Miglustat (Zavesca or NB-DNJ) is a drug approved for treatment of several rare lipid storage disorder diseases. In mice, it provided effective and fully reversible contraception. But it seems this effect was only true for several genetically related strains of laboratory mice. Miglustat showed no contraceptive effect in other mammals.[229]
    • Silodosin, an α1-adrenoceptor antagonist with high uroselectivity, approved by the FDA to treat Benign Prostatic Hyperplasia (BPH), has been shown to block the release of sperm during ejaculation when taken in at 5 times the dose used for treatment of BPH.[230][231]
    • Gamendazole, a derivative of lonidamine, shows semi-reversible infertility in rats. The mechanism of action is thought to be disruption of Sertoli cell function, resulting in decreased levels of inhibin B.[232]
    • Adjudin, a non-toxic analog of lonidamine has been shown to cause reversible infertility in rats.[233] The drug disrupts the junctions between nurse cells (Sertoli cells) in the testes and forming spermatids. Sperm are released prematurely and do not mature properly. Challenges were encountered relating to Adjudin's bioavailability and ability to cross the blood-testis barrier.[234]
    • Contraceptive immunization with sperm antigens has been found to be partially effective and reversible in male primates.[235]
  • Vas-Occlusive
    • The intra-vas device (IVD) was a rod-shaped device intended to be inserted into the lumen of the vas deferens via a small incision.[13][236]
    • The “Shug” was a noninjectable device consisting of 2 silicone plugs with nylon tails to help anchor the plug to the vas deferens, and was inserted via the no-scalpel scrotal puncture method.[237]
    • Injectable medical polyurethane was used as a vas-occlusive contraceptive for several hundred thousand men in China in the 1980s.[238][121]
  • Extracts of Natural Products
    • Researchers in 2010 fed extracts from the papaya seeds to monkeys. Subsequently, the monkeys had no sperm in their ejaculate, with no apparent ill effects on the testes or other organs.[239]

notes[edit]

  1. ^ The percentage of users of each method who will experience an unintended pregnancy in the first year of use of the method.

References[edit]

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