Clinical studies of male oral contraceptives reach a safety endpoint or soon to be marketed
March 21, 2018 Source: Sina Pharmaceutical
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];All along, about contraception, many products on the market are designed for women, including various contraceptives, contraceptives, contraceptive rings, etc.; and men, in addition to condoms and vas deferens, it seems that there is really no convenient contraception product. With regard to condoms, women often hear male companions complaining that "between me and you, separated by 0.03 mm"; and the vas deferens are ligated, except for those who have given birth, not many men are willing to accept this method.
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Well, the good news is coming, a male contraceptive that takes only once a day is expected to land in the market in the near future. Recently, researchers from the University of Washington School of Medicine brought their latest research: a new formula of male contraceptives, taken once a day for 1 month, successfully passed the clinical safety test. The findings will be announced this Sunday at the 100th Annual Meeting of the American Endocrinology Society (ENDO 2018) in Chicago, USA.
The male contraceptive, called dimethandrolone undecanoate (DMAU), combines the activity of the androgen testosterone with another hormone progesterone. The usage is to take it once a day for one month. Currently, the DMAU is being jointly developed by the National Institutes of Health and the Eunice Kennedy Shriver National Institute for Child Health and Human Development.
Dr. Stephanie Page, a senior researcher at the University and a professor of medicine at the University of Washington, said the DMAU is an important step in developing a daily male contraceptive. According to the survey, men prefer to use daily contraceptives as a reversible contraceptive rather than a long-acting injection or topical gel.
There have been many obstacles to the development of male contraceptives. The reason is that the existing oral form of testosterone may cause inflammation of the liver; and once a day, the drug is quickly cleared from the body, so it is necessary to take the drug twice a day. However, the new formulation used by DMAU has successfully bypassed this problem by formulating a long-chain fatty acid, undecanoate, which effectively delays the release of the drug component and delays the elimination of testosterone. At the same time, DMAU has successfully avoided liver safety problems. In the new drug trial, participants had complete normal liver and kidney function after 28 days of continuous medication.
The published study, a total of 100 healthy men, aged 18-50 years, was conducted at the University of Washington Medical Center and the Harbor-UCLA Medical Center. In the study, the researchers tested three different doses of DMAU (100 mg, 200 mg, 400 mg) and two different intracapsular formulations (castor oil, powder). In each dose group, 5 subjects were randomized to receive placebo and 12-15 subjects received DMAU. Subjects were given oral placebo or DMAU once a day and taken at mealtime for 28 consecutive days.
Page emphasizes that DMAU must be taken at the same time as food. Finally, a total of 83 men completed the study, and blood samples were taken on the first and last days of the study for hormone and cholesterol testing.
The data showed that in the highest dose group (400 mg DMAU), testosterone and two other hormone levels in the subject showed "significant inhibition", which are necessary for male spermatogenesis. Page stated that this low level is consistent with the effective male contraceptive results observed in long-term studies. Despite the low levels of testosterone in the circulatory system, few subjects reported symptoms associated with testosterone deficiency or overdose. In all groups taking DMAU, body weight did increase, while high-density lipoprotein cholesterol (HDL-C, "good" cholesterol) levels were reduced, but both cases were very mild. All subjects passed a safety check, including indicators of liver and kidney function.
Page, these exciting results are unprecedented in the development of male contraceptives. Long-term research is currently underway to confirm whether DMAU can prevent sperm production once a day.
But the question is, if this male contraceptive is successfully listed, how many men will voluntarily take this drug that can lower testosterone levels? If you are a male, would you like to take this medicine for your loved one?
If still a little hesitant? Another good news is that researchers at Monash University in Australia are developing a new hormone-free, oral male contraceptive that blocks sperm transport during ejaculation without disrupting sperm production, development and maturation. It also does not affect sexual desire and the contraceptive effect is reversible. Currently, the study is actively progressing, researchers said, the first convenient, safe, effective, reversible, non-hormonal oral male contraceptives are expected to land in the next 5-10 years. (Sina Pharmaceutical Compilation/newborn)
Article reference source:
1, Dimethandrolone undecanoate shows promise as a male birth control pill
2, First hormone-free male contraceptive pill soon to be a reality
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