US Study Confirms Safety And Efficacy Of Male Birth Control Gel

Recent advances in male contraception have yielded promising results, particularly with a gel-based contraceptive currently in clinical testing. This novel technique, supported by the NIH's Eunice Kennedy Shriver National Institute of Child Health and Human Development, is a key step towards giving males dependable and reversible birth control options.

Study Overview

The level 2 trial, conducted by scientists collaborating with the National Institutes of Health and Dr. Diana Blithe, involved 222 males. All men applied 5 milliliters of the hormone gel to their shoulders each day. An incredible 86% of the participants achieved sperm suppression, with effective contraception typically in less than eight weeks—more rapid onset than other methods using hormones.

The gel contains testosterone and Nestorone, a modified hormone once used in female contraceptives. This partnership allows faster sperm suppression using a lower dose of testosterone to solve the equitable slow onset that was witnessed in previous male contraceptive research. Testosterone alone can suppress sperm production in a median period of 15 weeks, but lowering the dose needed while accelerating the process is done effectively by the addition of progesterone acetate. This dual-action approach maintains blood testosterone levels within the physiological range, preserving normal sexual function and other androgen-dependent activities.

However, further trials are necessary to thoroughly examine the long-term effectiveness, safety, acceptability, and reversibility of this contraceptive method. The current findings, while promising, represent an initial step towards a viable male birth control option.

Challenges in Male Contraceptive Development

Despite the progress, there are significant hurdles to overcome before this contraceptive can be widely available. "We've been pushing for hormonal male contraceptives for 50 years, but there isn't enough money available to really drive something through a very large phase 3 trial," Daniel Johnston, chief of the National Institute of Child Health and Human Development's Contraception Research Branch, told NBC News.

However, if one male birth control medicine is approved by the US Food and Drug Administration, pharmaceutical companies may invest more resources in similar drugs, Johnston added.

"We've been chasing this for a long time," Johnston explained. "I hope we're entering new territory."

Impact on Contraceptive Choices

According to gynaecologist Dr. Brian Nguyen, one of the investigators on the gel clinical trials, surveys show that males are willing to utilise contraception. "By and large, they always say they'd be interested," said Nguyen, an associate professor of obstetrics and gynaecology at USC.

According to a 2023 study published in the journal Contraception, three-quarters of just over 2,000 male respondents intend to test new contraception. Heather Vahdat, executive director of the Male Contraceptive Initiative, says interest in male birth control has increased since the Supreme Court reversed Roe v. Wade in June 2022.

According to a recent study from the University of Pittsburgh School of Public Health, the number of young women and men opting for permanent birth control procedures such as vasectomy and tubal ligation has increased significantly since the court's decision. A similar study, performed in part by the Male Contraceptive Initiative, found that before the abortion ruling, 78% of men in the United States were interested in exploring new birth control techniques. Later, it rose to 82%.

"The demand has always been there, but there's a greater intensity now," Vahdat stated. "We get emails daily from people asking where they can sign up for clinical trials."

Unlike a vasectomy, the new contraceptive methods are intended to be reversible, allowing men to restore their ability to have children if desired.

Additional Research on Male Contraceptives

At the same Boston meeting, YourChoice Therapeutics unveiled a non-hormonal pill, YCT-529, which acts on a vitamin A receptor key to male fertility. Initial trials in the UK showed it to be safe and without side effects, prompting plans for more extensive studies.

World's 1st Male Contraceptive Clinical Trial

The Indian Council of Medical Research (ICMR) has recently achieved a significant milestone in the world of reproductive health by completing clinical trials for the world's first injectable male contraceptive. This groundbreaking development not only demonstrates its safety but also its high efficacy without any serious side effects. 

The findings of this phase-III clinical trial, involving 303 candidates aged 25-40 years, have been published in the international open-access Andrology journal, marking a historic moment in the field of contraception.

The phase-III clinical trials were open-labeled and non-randomized, and conducted at five different centers - New Delhi, Udhampur, Ludhiana, Jaipur, and Kharagpur. This massive undertaking was coordinated by the ICMR, New Delhi, and made possible with gracious permission from the Drugs Controller General India (DCGI) and the approval of the institutional ethical committees of the respective centres. This collaboration underlines the significance and trust vested in this pioneering research.

A New Chapter in Contraceptive Development

As part of this groundbreaking study, 303 healthy, sexually active and married men, and their healthy, sexually active wives, who had come to the family planning clinic and department of urology or surgery for vasectomy or No Scalpel Vasectomy (NSV), were identified. These courageous men were administered with 60 mg of Reversible Inhibition of Sperm under Guidance (RISUG).

The overall efficacy of RISUG in achieving azoospermia stood at an impressive 97.3 percent. Moreover, in terms of pregnancy prevention, the efficacy soared to 99.02 percent, all while remaining devoid of serious side effects.

This achievement marks a watershed moment in the history of contraceptive development. RISUG stands out as the most effective contraceptive method, surpassing both male and female alternatives. It is poised to become a vital component of mass contraception programs due to its unparalleled effectiveness.

Addressing the Global Need

With the world's population on the rise, there is an urgent need to develop modern methods of male contraception for effective population control. While vasectomy has proven to be an effective method, it does come with some limitations. The ideal male contraceptive approach should be minimally invasive, have a one-time injection, provide long-term effectiveness, and offer the option of reversal.

The RISUG Approach

RISUG embodies these qualities, offering a novel male contraceptive approach that addresses the shortcomings of current methods. It has the potential to become a widely used, injectable, and reversible male contraceptive method. Notably, this approach features localized injection and poses no detectable interaction with other parts of the body, distinguishing it from hormonal injectable contraceptives.

The successful completion of clinical trials for the world's first injectable male contraceptive marks a momentous stride in the realm of contraception. With its exceptional effectiveness and potential for mass use, RISUG promises a brighter and more convenient future for male contraception.

As the world faces population challenges, this revolutionary innovation offers hope for a balanced and controlled tomorrow.