Torrance, CA—Yesterday, LA BioMed announced the launch of two new Phase 2 male contraceptive studies. A preliminary study of the male contraceptive pill showed that the oral contraceptive appears to be safe and effective when taken daily. Current methods of male contraception are extremely limited and consist of vasectomy, condoms, withdrawal and fertility awareness, the latter two of which are unreliable at best.
“The demand for safe, non-invasive forms of male contraception cannot be ignored,” said LA BioMed President and CEO, Dr. David Meyer. “We are pleased with the progress toward a new male-directed contraceptive method.”
The Male Contraceptive Clinical Trial Center at LA BioMed, supported by National Institutes of Health (NIH) and National Institute of Child Health and Human Development (NICHD), is led by Drs. Ronald Swerdloff and Christina Wang. LA BioMed is teamed with a similar center at The University of Washington. According to clinicaltrials.gov, “This is a Phase IIa multicenter, double-blind, placebo-controlled study in healthy men to evaluate the spermatogenesis suppression after oral administration of Dimethandrolone Undecanoate (DMAU) alone or with Levonorgestrel (LNG) for 12 weeks versus placebo alone.”
Results from the initial study of the pill revealed that the experimental male oral contraceptive produced hormone responses that are consistent with effective male contraception seen in other longer-term studies. At the highest dose of DMAU tested, subjects showed marked suppression of testosterone levels and the two hormones required for sperm production, without showing change in mood or sexual function at the optimal dose.
“Single doses of DMAU up to 800 mg were well tolerated, safe and were not associated with any serious adverse events. Bioavailability of DMAU was markedly enhanced, nearly 80‐fold, when DMAU was administered with a high‐fat meal compared to administration while fasting. In this fed state, serum DMAU and DMA showed dose‐incremental pharmacokinetics,” according to the research from the first trial, published in Andrology. “DMA levels in the serum remained detectable 24 h after oral administration of 400 and 800 mg of DMAU with food suggesting that this formulation might be compatible with a daily dosing regimen.”
The second new male contraceptive trial at LA BioMed, supported by NICHD and the Population Council, will examine a gel contraception with testosterone and Nestorone. The gel, when applied to the skin, works to suppress the production of sperm and lower sperm counts in the ejaculate. The gel reduces the production of sperm without impacting men’s testosterone levels or ability to produce sperm at a later date.
Researchers at LA BioMed will oversee five of the nine centers worldwide conducting research on gel contraception for men. The 2b phase of this study will last 24 months and study approximately 420 couples. The endpoint will be contraception efficacy in the female partner.
“Public health researchers estimate that more than 40 percent of unplanned pregnancies would be avoided with better male contraception on the market,” said Dr. Christina Wang, LA BioMed lead researcher. Wang considers this research to be of paramount importance. “We are proud to lead national and international research on two innovative male birth control options that will have a significant impact on family planning options for the couple.”