“Our goal — as well as everyone’s goal in This specific field — is usually to develop a method for men in which has minimal side effects, as well as the holy grail might be to develop something in which also carries a health benefit for men,” Page said.
There are many birth control options for women, including hormone-based pills, injections as well as intrauterine devices. However, the menu of options is usually much smaller for men.
“The only options currently available for men are vasectomy, condoms as well as coitus interruptus,” Page said. “Forty percent of pregnancies worldwide are unplanned, so there’s clearly an unmet need for novel contraceptives, as well as men have very few options.”
Lowering testosterone levels
The completely new study relied on 83 men between the ages of 18 as well as 50 who were randomly assigned to either a control group or one of three treatment groups. Each treatment group received a different dosage of the drug: 100, 0 or 400 milligrams.
The group given 400 milligrams also saw a significant reduction in LH as well as FSH, two hormones in which help regulate testosterone as well as sperm production by the testes.
yet due to the study’s little sample size, more research is usually needed to evaluate the potential side effects of the drug within the general population, Cohen said.
“Nine participants had decreased libido, which is usually not little,” he said. “When you put in which on a large, multimillion-person basis, you have a huge portion of men running around with very low libido.”
Tricking the body
Finding a male birth control pill has been a medical goal since at least the 1950s, when scientists first began developing hormonal birth control options. Though “the pill” eventually gained popularity among women, hormonal birth control options for men never actually took off, according to Page.
“People have been working on male hormonal contraception for 40 to 50 years,” she said. “There are ways of delivering male contraceptives with long-acting implants as well as injections, yet men are interested in having an oral pill available, as well as the work we presented here is usually a step forward.”
The substance used within the study, DMAU, has properties similar to both androgens, such as testosterone, as well as progestins, such as progesterone. Consequently, the idea can “trick” the body into thinking in which testosterone levels are adequate, inhibiting the hormonal pathways in which ultimately lead to the production of sperm, according to Cohen.
The drug’s androgen-like properties are also supposed to prevent side effects typically associated with low testosterone levels, Page said.
“If you simply took the men’s testosterone down to these low levels, they might absolutely have side effects. They might have hot flashes just like women do when they go through menopause, as well as they might have marked modifications in sexual desire as well as function,” she said.
“The very important point here is usually in which despite having those low levels of testosterone, the steroid in which is usually given in This specific prototyped male pill provides the androgen activity within the man in all the different parts of their body,” Page added.
Successes as well as limitations
Due to these side effects, 20 out of 320 participants dropped out of in which study.
yet the newest drug, DMAU, showed a marked reduction in many of these unwanted effects. the idea also did not appear to damage the liver, a known consequence of testosterone use, according to Page.
“We looked at markers of liver inflammation very closely as well as didn’t see anything concerning, producing sure in which’s very important,” she said.
yet the short study period of only 28 days makes the idea difficult to know whether liver damage could have occurred with long-term use of the drug, Cohen cautioned.
The study also did not measure sperm count, one of the study’s main limitations.
yet according to Page, the research team succeeded in achieving its primary objective: identifying an effective as well as potentially safe dose of DMAU.
“The original study was actually designed to find a dose to move forward with, as well as we were able to accomplish in which as well as demonstrate in which there were no acute safety concerns.”
the idea also opened the door for future research in which is usually already within the works, she said.
“The important next step is usually to show in which This specific does in fact suppress the production of sperm, as well as in which requires at least a three-month study, which we’re going to be undertaking starting next month,” Page added.
“After in which, we’ll need longer-term studies to look in detail about fine-tuning any potential side effects as well as ultimately doing a study in couples in which actually demonstrates in which the idea works in a real-world use.”