The experimental hormone-free male contraceptives passed the initial safety test in humans.
The trial included 16 people and was solely intended to test whether the drug had reached an appropriate level in the body and whether it caused serious side effects such as heart rate, hormonal function, inflammation, mood and sexual function changes.
No significant side effects were observed across the doses tested. As a result, we will tee pills that will be tested in large-scale trials examining both safety and efficacy.
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The results of the early safety trials published in the Journal Communications Medicine on Tuesday (July 22) are described by Dr. Stephanie Page, an endocrinologist at the University of Washington School of Medicine who is not involved in the study, told Scientific American. “We really need more reversible birth control methods for men,” she added.
At the moment, the only options for male birth control are condoms and vascular resection. The latter can be reversed, but the actual success rate of the inversion procedure differs significantly in the way that a person may then become pregnant with the child. If approved, the new pill will be the first drug in its class.
“Safe and effective male tablets offer more options for couples for contraception,” said Ganda Georg, professor at the University of Minnesota Pharmacy University where the drug molecule was developed, in a statement released earlier this year after a promising preclinical trial of the pill. Columbia University was also involved in the development of the drug, along with Company Your Choice Therapeutics, which oversees the examinations.
Related: Why are there no birth control pills for men yet?
“It would allow for a more equitable sharing of responsibility for family planning and provide reproductive autonomy for men,” Georg said.
How male birth control pills work
An experimental drug called YCT-529 is designed to suspend sperm production by interrupting certain signals in the body.
Specifically, this drug works by blocking proteins called “retinoic acid receptor alpha.” It is known to play an important role in sperm formation and maturation. In the testes, receptors are usually activated by insertion of a “key” (vitamin A metabolite), but this key stops this key from clicking. It prevents a chain reaction that ends with sperm being produced.
To find a compound with this effect, scientists had to closely examine the structure of the receptor when it bound to the key, and tested dozens of molecules to see if they could block interactions.
In a preclinical trial using male laboratory mice, the drug “induced a severe effect” on sperm production. It caused reversible infertility within 4 weeks of use, and treated men showed 99% effectiveness in preventing pregnancy in conjugated female mice. When the drug was removed, the fertility of male mice recovered within about 4-6 weeks.
Further testing of non-human primates returned similar results, with a dramatic decrease in sperm count within two weeks of starting the drug and a full recovery within 10-15 weeks of stopping the drug. These preclinical tests set the stages of recent clinical trials for people.
The trial included 16 men between the ages of 32 and 59, all of whom had previously undergone vascular resection. This was done from abundant care when experimental drugs have a lasting effect on fertility on Nadja Mannowetz, co-founder and chief science officer of Youchoice Therapeutics.
Participants were divided into groups receiving either placebo pills or low or high doses of medication. Most participants only took tablets after the fasting period, but the subset was administered after a large meal to determine whether the level of the drug’s disease was at an intrabody level.
Over all doses and conditions tested, drug levels in the body reached decent levels, but Mannowets expects the final dose to be closest to 180 milligrams, if approved, to the closest dose to the highest tested dose.
Both animal studies and human trial results suggest that approved drugs are likely to be taken once a day, but further studies will confirm their administration. Additionally, although this small trial did not have any significant side effects, future trials with larger study cohorts should monitor these effects.
“The positive results of this first clinical trial laid the foundation for the second trial receiving YCT-529 for 28 and 90 days, studying the safety and changes in sperm parameters,” the study author wrote in the paper. The trial is already underway, and we see a man who has been undergoing vascular resection again or has made a firm decision that he is not a father’s child.
This article is for informational purposes only and is not intended to provide medical advice.
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