A contraceptive pill for men passes a first phase of tests

Women have access to a wide range of oral contraceptive products, most of which use one or more hormones, since the 1960s. After years of research, a male contraceptive pill could also become a reality.

US researchers have announced that a hormonal contraceptive for men, named 11-Beta-MNTDC, has just passed a first clinical study .

This is the second time that such an oral contraceptive has achieved this goal, following a 2018 study , the results of which were released earlier this year. These two studies were made by the same team.

The new product, which was announced at the annual meeting of the American Society of Endocrinology, is also a derivative of this first molecule.

Its operation is similar to that of the contraceptive pill for women, so it represents a first step towards the marketing of a hormonal contraceptive for men.

Male fertility is mainly regulated by two hormones – abbreviated as LH and FSH. These hormones are generated in different areas of the body and migrate to the testes, where they activate the production of sperm and testosterone.

The new pill interferes with this process thanks to a modified form of testosterone, which lowers the levels of hormones regulating sperm production, but the hormonal changes have no adverse effects on the rest of the body.

It is a progesterone-like molecule that will block the production of LH and FSH, reducing the production of both sperm and testosterone.

To counteract the fall of this hormone, the pill will have a second effect similar to an androgen, simulating the effect of testosterone in the rest of the body, which counterbalances its decrease while fulfilling its role as a contraceptive.

No side effects during testing

For 28 days, 40 men aged 18 to 50 received different doses of the product to see what side effects there could be in humans.

Fourteen participants were given 200 milligrams of the product, 16 received 400 milligrams and 10 received a placebo. The researchers then monitored the participants’ state of health and hormone levels during the Phase 1 clinical trial, which was designed to assess the safety of the product.

The researchers did not observe any significant side effects during this period.

However, participants experienced more fatigue, some problems with acne, weight gain or headaches. Five participants also reported experiencing a decline in sex drive and two reported experiencing mild erectile dysfunction episodes.

The researchers did not give the drug to the subjects long enough to be able to notice a difference in their sperm count, which requires continuous use for 60 to 90 days.

The latter still noticed a decline in FSH and LH levels in all participants, except those who took the placebo. The effect was sufficient for longer use to reduce the number of sperm to levels that would be equivalent to effective contraception.

In addition, the effects were reversible once the participants stopped taking the product.

These early results should now lead to a longer study to see the real effect on sperm production. If successful, the researchers will then go on to experiment with sexually active couples, at which point they will be able to conclude whether this product is as effective as female contraceptive pills.

The researchers warn that it will take another decade of clinical studies and regulatory assessment before such pills are marketed.

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