A new male contraceptive pill has passed the safety and tolerability tests with healthy men, who used it daily for a month, with compatible hormonal responses with effective contraception, according to researchers from two institutions that have tested the drug. The results of the Phase 1 study were presented last Sunday at ENDO 2019, the annual meeting of the American Endocrine Society, which is being held in New Orleans.
The experimental male oral contraceptive is called 11-beta-methyl-19-nortestosterone dodecylcarbonate, or 11-beta-MNTDC. It is a modified testosterone that has the combined actions of a male hormone (androgen) and a progesterone, explains the study's lead researcher, Christina Wang, associate director of the Institute of Clinical and Translational Science at the Biomedical Research Institute of Los Angeles (LA BioMed ), in Torrance (California). "Our results suggest that this pill, which combines two hormonal activities in one, will decrease sperm production while preserving libido," Wang says.
The study was conducted in 40 healthy men at LA BioMed and at the University of Washington in Seattle. Ten participants received a placebo pill randomly. The other 30 men took 11-beta-MNTDC in one of two doses: 14 men received 200 milligrams and 16 received a dose of 400 milligrams. The subjects took the drug or the placebo once a day with food for 28 days. The National Institute of Child Health and Human Development Eunice Kennedy Shriver, which is developing 11-beta-MNTDC and other male contraceptives, funded this study.
Among men who received 11-beta-MNTDC, the average level of circulating testosterone was reduced as low as if it were sterile by androgen deficiency, but participants did not experience any serious side effects. Just mild fatigue, acne or headache. Five men reported having a slight decrease in sexual desire, and two men described mild erectile dysfunction, but sexual activity did not decrease. In addition, no participant stopped taking the medication due to side effects, and all passed the safety tests.
Reversible effects after stopping the medication
The effects due to the low level of testosterone were minimal, according to the assistant researcher, Stephanie Page, professor of Medicine at the University of Washington School of Medicine, "because 11-beta-MNTDC mimics testosterone throughout the rest of the body , but it is not concentrated enough in the testicles to support the sperm production ". The levels of two hormones required for sperm production dropped considerably compared to placebo, the researchers found. The effects of the drug were reversible after stopping treatment, Wang notes.
Because the drug would take at least 60 to 90 days to affect sperm production, 28 days of treatment is too short an interval to observe optimal sperm suppression, Wang explains. He plans longer studies and, if the medication is effective, will pass new tests, also in sexually active couples. "Safe and reversible male hormonal contraception should be available in approximately 10 years," Wang predicts.
Wang points out that lMost men do not rule out using these male contraceptives. Quote a multinational survey of 9,000 men published in the magazine Human Reproduction In February 2005 he found that 55% of those who have stable relationships want to try new male hormonal contraceptive methods if they are reversible.
This experimental contraceptive, 11-Beta-MNTDC, is a "sister compound" of dimethanedrone undecanoate, or DMAU, the first potential male contraceptive pill that is undergoing testing by the same research team. Their results were published on February 1 of this year in The Journal of Clinical Endocrinology and Metabolism.
"The goal is to find the compound that has fewer side effects and is the most effective," Page says. "We are developing two oral medications in parallel in an attempt to move the field forward. [de la medicina anticonceptiva]"