The Endocrine Society published a report in March regarding the testing status of oral contraceptives for men. The results were positive, and the testing will progress to the next two stages.
“The first phase of the testing strictly dealt with toxicity and safety,” explained Dr. Edward Cherullo, a urologist and faculty member at Rush University in Chicago. “That’s always the first step of any new medication, to test for toxicity at the level needed for the medicine to perform as planned. Those tests went well, so phases two and three can begin soon.”
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. Testing is being conducted at the Los Angeles Biomed Research Institute in Torrance, California.
The study involved 40 healthy men at LA BioMed and the University of Washington in Seattle. Ten participants randomly received a placebo capsule, and the other 30 received 11-beta-MNTDC at one of two doses; 14 men received 200 milligrams, and 16 got 400 milligrams. Subjects took the drug or placebo once daily with food for 28 days.
“The pill lowers the ability to create sperm,” Cherullo said. “During testing, the pill did not decrease the men’s libido or result in erectile dysfunction issues. Basically, it acts like a temporary vasectomy in pill form. Once you’re off the pill, the body begins to create live sperm, and the male becomes fertile again in 90 to 100 days.”
Levels of two hormones required for sperm production dropped greatly compared to placebo, the researchers found. The drug effects were reversible after stopping treatment, according to the publication. Plans are now in place to conduct longer studies, and if the drug is effective, it will move to larger studies and testing in sexually active couples.
Cherullo has a special interest in the progress of male contraceptives. “I see quite a few male patients who want more control over their own role in reproduction,” he said. “I get asked about reversible vasectomies, and if there are any other options besides condoms. So there is a lot of interest from men in being part of the whole process.”
Most urologists, Cherullo included, shy away from reversing a vasectomy. “There are issues that include a higher risk of infection, bleeding, and not really reversing the sterility,” he said. “That’s why we counsel men to be sure they understand it’s usually a permanent procedure.”
The Endocrine Society also believes that the majority of men are open to using this type of male birth control. Its publication cited a multinational survey of 9,000 men published in the journal Human Reproduction in February 2005 that found that 55% of men in stable relationships want to try new, hormonal male contraceptive methods if they are reversible.
This experimental contraceptive, 11-Beta-MNTDC, is a “sister compound” to dimethandrolone undecanoate, or DMAU, the first potential male birth control pill to undergo testing by the same research team. Their results were published Feb. 1 in The Journal of Clinical Endocrinology and Metabolism.
The goal is to find the compound that has the fewest side effects and works best, according to the publication. The researchers are currently developing two oral drugs in parallel in an attempt to move the contraceptive medicine field forward.