Current and Future Options for Male Contraception

By Maria F. Gallo, PhD

Professor and Associate Dean of Research, College of Public Health, Division of Epidemiology, The Ohio State University, Columbus

Following the landmark Dobbs v. Jackson Women’s Health Organization decision that ended the constitutional right to abortion in the United States, the importance of contraception has grown. The following summarizes the existing male contraceptive options and reviews the status of future ones. Note that the term “male contraception” is used throughout to refer to methods to be used by men and any other people who produce sperm.

Three Current Methods

Currently, three methods of male contraception are available: vasectomy, condoms, and withdrawal. Vasectomy involves cutting each vas deferens and then tying or sealing them to prevent sperm from entering into the ejaculate. In the United States, most vasectomies are performed with the no-scalpel approach under local anesthesia by urologists in an outpatient setting.¹ The no-scalpel method uses a sharp-pointed, forceps-like instrument to puncture the skin. Vasectomy is highly effective and safe. The failure rate with typical use is defined as the percentage of women experiencing an unintended pregnancy during the first year of relying on their partner’s vasectomy. The failure rate with typical use is 0.15%, and most failures occur in the first three months after the procedure.² Compared to tubal ligation, vasectomy is quicker, less invasive, and less expensive to perform.

Despite its many benefits, the use of vasectomy in the United States is low. An estimated 18.1% of reproductive-age women used female permanent contraception for contraception in 2017-2019; in contrast, only 5.6% relied on their partner’s vasectomy.³ A large study of insurance claims data from 2007-2015 found that vasectomy rates peak at the end of the calendar year (presumably because of people reaching their insurance deductible or having time off work) and during March (presumably as the result of promotions encouraging people to schedule their recovery to coincide with watching the “March Madness” basketball tournament).¹ This study also found that the frequency of undergoing vasectomy decreased during the study period (2007-2015).

A complicated set of values and beliefs could contribute to men’s unwillingness to use vasectomy. For example, some men mistakenly believe that vasectomy will negatively affect their sexual performance or sensation.⁴ Also, some believe that while “tubes can be untied” with tubal ligation, vasectomy can never be reversed.⁵ Vasectomy, though, sometimes can be reversed. A systematic review by Namekawa et al reported mean patency (defined as return of sperm to the ejaculate) and pregnancy rates of 87% and 49%, respectively, following vasectomy reversals.⁶ Estimates of reversal effectiveness vary widely in individual studies, in part because successful reversal appears to be dependent on numerous factors, such as patient age and time since vasectomy. Because reversibility cannot be guaranteed for individuals, and because of the costs and burdens associated with both vasectomy and its reversal, providers typically counsel people to consider vasectomy to be a permanent method.

Male condoms are inexpensive, safe methods of contraception. About 8.4% of reproductive-age women in the United States report using condoms with their partner.³ The failure rate with perfect use is 2% but increases to 13% with typical use.² Today’s failure rate with typical use is lower than the previous estimate of 18%, suggesting that people might have become more proficient in using condoms. An individual couple’s likelihood of pregnancy when using condoms can vary according to how well they use condoms. Pregnancies among condom users often derive from people not using condoms correctly and consistently for the entire sex act because they do not like the way that the condom feels or its effects on the erection or the sexual act.

The third available method, withdrawal, is less effective than many other contraceptive methods. The failure rate with perfect use is 4% but is 20% with typical use.² Measuring the prevalence of withdrawal use can be difficult. For example, some people who use withdrawal might not think of this when asked to report on their methods used, or they might be reluctant to admit that they use such an ineffective method. Also, the use of withdrawal can vary by the act: some condom users selectively substitute withdrawal in place of using a condom based on their perception of their partner’s likelihood of having a sexually transmitted infection. Withdrawal often is combined with another method or methods. For example, some people combine withdrawal with condom use to improve their overall protection against pregnancy from the sexual act. Or they might use withdrawal because they are using another method only inconsistently. Although withdrawal alone has low effectiveness for protecting against pregnancy, combined with other methods, it could add another layer of protection.

Future Methods

New options under development for male contraception include drugs and other methods. Nonhormonal drugs are being studied; however, these generally still are in the early, preclinical stage. Hormonal methods for male contraception typically consist of testosterone and a progestin or drugs that function in similar ways. The progestin interferes with the production of sperm while the testosterone is included to reduce side effects. The goal is to reduce sperm counts to below the level that is thought to be needed to be fertile. Different delivery methods are possible, such as an oral pill, an injection, or a gel to be applied to the skin.

Several promising agents are being developed and tested. The one furthest along in testing is a gel containing nestorone and testosterone, which currently is being tested in a multisite contraceptive efficacy trial of about 420 couples.⁷ The timeline for approval of a drug for male contraception is likely to be long for several reasons. First, regulatory approval for a new hormonal method for women typically has required at least 20,000 cycles from at least a year of use to assess safety and effectiveness. Also, a male method will need to have a strong long-term safety record because men do not personally face health risks from pregnancy. It is not clear how the U.S. Food and Drug Administration will weigh the risk-to-benefit ratio under this new scenario in which the risks of the drug are borne by an individual whose partner then has the benefits of avoiding pregnancy-related health risks.

A nondrug method, Vasalgel, consists of a polymer that, after being injected into the vas deferens, acts as a barrier that stops the passage of sperm while still allowing ejaculation to pass through.⁷ Vasalgel is based on a method, reversible inhibition of sperm under guidance (RISUG), that was tested in Phase III clinical trials in India in 2000, which had promising findings. However, when the World Health Organization completed a site visit, they questioned the researchers’ adherence to international standards. In 2010, a foundation in the United States bought intellectual property rights to RISUG, which they used to develop Vasalgel. A primary advantage to Vasalgel is that the polymer is thought to be able to be easily flushed out with a solution of sodium bicarbonate to restore fertility. While pre-clinical trials have been conducted in rabbits and monkeys, the timeline for completing the required clinical trials in humans is likely to be lengthy.

Another non-drug method is thermal male contraception (TMC). TMC takes advantage of the fact that heat can kill sperm and interfere with sperm production. Testicular temperature is usually 2°C to 5°C lower than a person’s overall body temperature. Raising testicular temperature by about 2°C for several months could be enough to cause temporary infertility. One approach currently under testing involves wearing specially designed compression underwear that raises the testicles into a position near the root of the penis and then holds them in place. Initial testing was conducted among 51 couples who used TMC for 15-24 hours daily for 536 cycles without using any other contraceptive method.⁸ No pregnancies were detected. The acceptability of consistently wearing the underwear is likely to differ across people.

New condoms have been designed to increase sexual pleasure by modifying the size, shape, or feel of the device or by making the condom out of new materials. A novel condom containing an erectogenic compound was designed to increase sexual pleasure by increasing the penile blood flow and thereby increase erection hardness.⁹ In a randomized controlled trial, both men and women reported increased pleasure with the erectogenic condom compared to the standard control condom. However, whether the new condom will make it to market in the United States is unknown.

Conclusion

About 45% of pregnancies in the United States are unintended. Access to contraception and abortion has allowed people to delay or avoid having offspring, which has improved their opportunities to pursue educational and career options. Reduced access to abortion following the Dobbs case is putting this reproductive autonomy into jeopardy. Although contraception cannot prevent all unintended pregnancies or prevent all pregnancies that need abortion care, consistent use of effective contraception helps reduce both. At this time, people might be more open to learning about and pursuing their contraceptive options, and male contraception should be part of this discussion.

REFERENCES

1. Ostrowski KA, Holt SK, Haynes B, et al. Evaluation of vasectomy trends in the United States. Urology 2018;118:76-79.
2. Trussell J, Aiken ARA, Micks E, et al. Efficacy, safety, and personal considerations. In: Hatcher RA, Nelson AL, Trussell J, et al, eds. Contraceptive Technology. 21st ed. Ayer Company Publishers, Inc.; 2018.
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6. Namekawa T, Imamoto T, Kato M, et al. Vasovasostomy and vasoepididymostomy: Review of the procedures, outcomes, and predictors of patency and pregnancy over the last decade. Reprod Med Biol 2018;17:343-355.
7. Long JE, Lee MS, Blithe DL. Update on novel hormonal and nonhormonal male contraceptive development. J Clin Endocrinol Metab 2021;106:e2381-e2392.
8. Joubert S, Tcherdukian J, Mieusset R, Perrin J. Thermal male contraception: A study of users’ motivation, experience, and satisfaction. Andrology 2022;10:1500-1510.
9. Gallo MF, Nguyen NC, Luff A, et al. Effects of a novel erectogenic condom on men and women’s sexual pleasure: Randomized controlled trial. J Sex Res 2022;59:1133-1139.