Despite years of research and trials, contraceptives for men have been a far-reality. The recent study by the Indian Medical Research Council (ICMR) published in the journal Andrology in October 2023 showed that the world’s first injectable male-contraceptive drug, RISUG (Reversible Inhibition of Sperm Under Guidance) was seen 99.9% effective in preventing pregnancy as shown in the phase-III clinical trials. However, experts say that it is too soon to comment on side effects as the drug was tested on a selected group of individuals.
This study looked at the safety and efficacy of RISUG, an alternative to surgical vasectomy for male sterilization. The study was conducted on 303 healthy, sexually active and married male subjects (aged 25-40 years) and their healthy and sexually active wives. Data was collected (before and after the injection) based on vital organ and scrotum ultrasounds, chest X-rays, blood, sperm, urine examinations, and other measurements.
At 21 days post-injection, 77.2% and 13.5% subjected achieved azoospermia and oligozoospermia with non-motile sperms, respectively. Afterwards the percentage of the subjects achieving azoospermia increased to 97.2% at 6th month post-injection and reached to the highest level of 97.3% after 1-year post-injection, according to the study.
The efficacy of RISUG was based on two factors: protection against pregnancy, and viability of sperm. RISUG showed effective results in both factors.
Stereotypic approach towards male contraceptives
Contraception methods for men have been in use for many years, but the burden of family planning has always been placed on the female population. Dr Shashidhar B, an andrologist at Manipal Hospitals, Bangalore explains that for a long time, there has only been one male contraceptive method available, which is vasectomy.
“However, unlike tubectomy, which is a safe method for females, vasectomy was not accepted by the male population due to its stereotyped approach towards male contraceptives,” he said. In some cultures, vasectomy was seen to affect the masculinity of the men, but with this new research there will be a change, the expert added.
Is ICMR’s male contraceptive safe?
While women have many options for long-term and reversible contraceptives (contraception method that doesn’t have to be used or applied more than once a cycle or a month), men have been restricted to single-use contraceptives such as condoms or those that are difficult to reverse, such as vasectomies, which can lead to harmful effects on blood parameters, clotting problems, and even affect heart health, says Dr Shashidhar.
“Other problems associated with male contraceptives include hormonal issues and higher failure rates. Using condoms can sometimes lead to allergies, as well as other side-effects such as acne in men,” he added.
However, the clinical evaluation of RISUG revealed no serious side-effects, such as pyrexia (an increase in body temperature above normal), local inflammation at injection and reproductive system, and urinary system infection.
There was no sign of urethritis (inflammation of the urethra), vasculitis (inflammation of seminal vesicles), cystitis (inflammation of the bladder), prostatitis (painful condition that involves inflammation of the prostrate), epididymitis (tube at the back of the testicles become swollen), orchitis (an inflammation of one or both testicles) and dysuria (painful urination) was reported post RISUG injection, according to the study.
A step forward in male contraceptives
According to experts, RISUG may be considered one of the top contraceptive options for the male population. ICMR’s RISUG male contraceptive is a step forward in the field of male contraceptives, but its long-term effects can only be evaluated once people start using it, Dr T Manohar, chief urologist, Apollo Hospitals, Bangalore said.
Meanwhile, there are still several studies to be conducted, including a clinical reversibility study, post-marketing surveillance, and obtaining a license to manufacture RISUG at a Good Manufacturing Practice (GMP) facility.
Takeaways
- The Indian Council of Medical Research (ICMR) recently made a breakthrough in the field of birth control with the completion of the clinical trials of the world’s first injectable male contraceptive drug, RISUG.
- The efficacy of the drug was determined by two factors- one was the protection against pregnancy and the other was the viability of the sperms.
- Experts, however, say that RISUG is one of the top alternatives for birth control methods. But its long-terms effects can only be assessed once it’s administered to individuals.
