Current and Future Options for Male Contraception
January 30, 2023 7 minutes read
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 is a summary of the existing male contraceptive options and an overview of future ones. Note the term “male contraception” is used throughout to refer to methods to be used by men and any others who produce sperm.
THREE CURRENT METHODS
There are three available male contraceptives: vasectomy, condoms, and withdrawal. Vasectomy involves cutting each vas deferens and tying or sealing them to prevent sperm from entering the ejaculate. In the United States, urologists perform most vasectomies in an outpatient setting with the no-scalpel approach under local anesthesia.1 In this method, the surgeon 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 cheaper. Despite its many benefits, vasectomy rates in the United States are low. An estimated 18.1% of reproductive-age women used female permanent contraception in 2017-2019; in contrast, only 5.6% relied on their partner’s vasectomy.3 A study of insurance claims data from 2007-2015 revealed vasectomy rates peak at the end of the calendar year (presumably because people reach their insurance deductible or take time off work) and during March (presumably because of promotions encouraging people to schedule their recovery to coincide with watching the “March Madness” basketball tournament).1 This study also revealed the frequency of undergoing vasectomy decreased during the study period.
A complicated set of values and beliefs could contribute to men’s unwillingness to use vasectomy. For example, some men mistakenly believe vasectomy will negatively affect their sexual performance or sensation.4 Also, some believe that while “tubes can be untied,” vasectomy can never be reversed.5 Vasectomy sometimes can be reversed. A systematic review revealed 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 and safe. 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 people might be more proficient in using condoms. A couple’s likelihood of pregnancy when using condoms can vary according to how well they use them. 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 the condom feels or its effects on the erection or the sexual act.
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 can be difficult. For example, some people who withdraw might not think of this when asked to report on their methods, or they might be reluctant to admit they use such an ineffective method. Also, 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. For example, some combine withdrawal with condom use to improve their overall protection against pregnancy. Or they might withdraw because they are using another method only inconsistently. Although withdrawal alone is ineffective, combined with other methods, it could add another layer of protection.
FUTURE METHODS
New options under development for male contraception include drugs. Nonhormonal drugs are under investigation; however, these generally are in the early, preclinical stage. Hormonal methods for male contraception typically consists of testosterone and a progestin or drugs that function in similar ways. The progestin interferes with sperm production while testosterone is included to alleviate 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 applied to the skin.
Several promising agents are in development. A gel containing Nestorone and testosterone is undergoing testing in a multisite efficacy trial that includes about 420 couples.7 The timeline for a male contraception drug likely will be long. 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 show a strong long-term safety record because men do not personally face health risks from pregnancy. It is not clear how the FDA 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 can avoid pregnancy-related health risks.
A nondrug method, Vasalgel, consists of a polymer that after injection into the vas deferens acts as a barrier that stops the passage of sperm while still allowing ejaculation.7 Vasalgel is based on reversible inhibition of sperm under guidance (RISUG), that was tested in Phase III clinical trials in India in 2000, which was promising. However, when the World Health Organization completed a site visit, they questioned the researchers’ adherence to international standards. In 2010, a U.S. foundation bought intellectual property rights to RISUG, which they used to develop Vasalgel. A primary advantage to Vasalgel is the polymer is thought to easily flush 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 likely will be lengthy.
Thermal male contraception (TMC) takes advantage of the fact 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 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 enhance 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 speeding penile blood flow, thereby intensifying erection hardness.9 In a randomized, controlled trial, men and women reported more pleasure with the erectogenic condom vs. the standard control. 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 pregnancy, which has improved their opportunities to pursue educational and career options. Less 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.
3. Daniels K, Abma JC. Current contraceptive status among women aged 15-49: United States, 2017-2019. NCHS Data Brief 2020;Oct:1-8.
4. White K, Martínez Órdenes M, Turok DK, et al. Vasectomy knowledge and interest among U.S. men who do not intend to have more children. Am J Mens Health 2022;16:15579883221098574.
5. Shih G, Dubé K, Sheinbein M, et al. He’s a real man: A qualitative study of the social context of couples’ vasectomy decisions among a racially diverse population. Am J Mens Health 2013;7:206-213.
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.
The following is a summary of the existing male contraceptive options and an overview of future ones.
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