A new male birth control pill has successfully passed initial safety and tolerability tests in humans
A team of scientists announced that a new male birth control pill has successfully passed initial safety and tolerability tests in humans.
The once-daily pill has been found to produce hormone responses consistent with effective contraception, said the study.
The study was published in The Journal of Clinical Endocrinology and Metabolism.
Although various methods of female contraception including oral pills have been available for over seven decades, male contraception has remained limited to the use of condoms.
Other methods like withdrawal have high failure rates. On the other hand vasectomy is complicated as it involves surgical management and there are varying degrees of reluctance the world over about the procedure.
The development of an effective male contraceptive pill has failed so far as men metabolise and clear out the hormones quickly
Till date, hormonal male contraceptive methods in clinical trials have primarily used testosterone (T) gels, injections, or implants, with or without a progestin. The addition of a progestin to T increases the proportion of men who suppress their sperm concentration to less than 1 million/mL , a level consistent with more than 97% contraceptive efficacy.
The development of an effective male contraceptive pill has failed so far as men metabolise and clear out the hormones quickly.
The new drug, called dimethandrolone undecanoate, or DMAU, includes a long-chain fatty acid which slows down the clearance, allowing just one dose to be taken each day.
The study included 100 healthy men (18 to 50 years old) in good general health with normal reproductive function and 83 completed the study. They were randomly divided into five groups with 15 in each group receiving three doses of DMAU – 100, 200 and 400 mg (in either 70% castor oil/30% benzyl benzoate or powder capsule) and 5 in each group receiving placebo or dummy pill.
Results showed that daily oral administration of DMAU for 28 days in healthy men is well tolerated. Doses of 200 mg or more suppress serum T, LH, and FSH, properties consistent with an effective male contraceptive without significant changes in sexual function or signs of liver toxicity.
Side effects were mild, such as headaches, acne, lower sex drive or tiredness but six of the eight subjects who reported decreased libido received the 400-mg dose.
No significant change in sexual activity, erection, or mood was noted during psychological assessment. The trial also observed an average weight gain of less than 5% from baseline weight (depending on the dose) and a drop in serum HDL-Cholesterol concentrations of approximately 6 to 15 mg/dL.
“Our results suggest that this pill, which combines two hormonal activities in one, will decrease sperm production while preserving libido,” said co-senior investigator Prof Christina Wang.
