A novel male contraceptive gel combining two hormones, segesterone acetate (named Nestorone) and testosterone, suppresses sperm manufacturing sooner than related experimental hormone-based strategies for male contraception, in keeping with a brand new research.
Outcomes from an ongoing multicenter section 2b medical trial can be introduced Sunday at ENDO 2024, the Endocrine Society’s annual assembly in Boston.
The event of a secure, extremely efficient and reliably reversible contraceptive methodology for males is an unmet want. Whereas research have proven that some hormonal brokers could also be efficient for male contraception, the gradual onset of spermatogenic suppression is a limitation.”
Diana Blithe, Ph.D., senior researcher, chief of the Contraceptive Growth Program on the Nationwide Institutes of Well being (NIH) in Bethesda, Md.
NIH’s Eunice Kennedy Shriver Nationwide Institute of Little one Well being and Human Growth is funding the research, which included 222 males who accomplished not less than 3 weeks of every day remedy with the contraceptive gel. The gel contained 8 milligrams (mg) of segesterone acetate and 74 mg of testosterone. Segesterone acetate is an ingredient of the Annovera vaginal contraception ring. Males utilized the gel as soon as every day to every shoulder blade.
Early within the research, the researchers measured for suppression of sperm manufacturing by acquiring sperm rely exams at 4-week intervals. The edge deemed efficient for contraception was 1 million or fewer sperm per milliliter of semen, Blithe famous.
Most research individuals (86%) reached this sperm rely by week 15, the researchers reported. Amongst these males, sperm manufacturing was suppressed at a median, or midpoint, time of lower than 8 weeks of segesterone-testosterone remedy. Blithe mentioned prior research of male hormonal contraceptives given by injections confirmed a median time between 9 and 15 weeks for sperm output to grow to be suppressed.
“A extra fast time to suppression could enhance the attractiveness and acceptability of this drug to potential customers,” Blithe mentioned.
Testosterone remedy alone decreases sperm manufacturing, with a median time of 15 weeks however the addition of segesterone acetate speeds the time and lowers the dose of testosterone wanted to suppress sperm manufacturing over testosterone alone, she mentioned. Within the every day segesterone-testosterone gel routine, blood ranges of testosterone are stored within the physiologic vary to take care of regular sexual operate and different androgen-dependent actions.
The sperm suppression stage of the worldwide section 2b trial of segesterone-testosterone gel is full. The research continues to check the contraceptive’s effectiveness, security, acceptability and reversibility of contraception after remedy stops.