Jalees Rehman investigates research into hormonal contraceptives for men:
One of the largest male contraceptive efficacy trials ever conducted was sponsored by the World Health Organisation (WHO) and CONRAD, the US-based reproductive health research organisation. Called Phase II TU/NET-EN, this landmark multicentre study was designed to answer key questions about the long-term safety and efficacy of male hormonal contraception, and enrolled more than 200 couples between 2008 and 2010. The contraceptive used was a long-acting formulation of testosterone (testosterone undecanoate, or TU) combined with a long-acting progestin (norethisterone enanthate or NET-EN), administered via injections every two months. The trial included an initial treatment phase to suppress sperm production, and a subsequent ‘efficacy phase’ that required couples to rely exclusively on this form of birth control for one year. However, in April 2011, the trial was terminated prematurely when the advisory board noticed a higher than expected rate of depression, mood changes and increased sexual desire in the study volunteers. By the trial’s end, only 110 couples had completed the one-year efficacy phase; their efficacy results should be released in the near future. …
The discontinuation of the WHO/CONRAD trial was a major setback in bringing male contraceptives to the market. It also raised difficult ethical questions about how to evaluate side effects in male contraceptive trials.
Since all medications are bound to exhibit some side effects, what side effects should be sufficient to halt a trial? Female contraceptives have been associated with breakthrough bleeding, mood changes, increased risk of blood-clot formation, as well as other side effects. Why should we set a different bar for male contraceptives?
The twist here is that female contraceptives prevent unintended pregnancies in the person actually taking the contraceptive. Since a pregnancy can cause some women significant health problems, the risk of contraceptive side effects can be offset by the benefit of avoiding an unintended pregnancy. However, men do not directly experience any of the health risks of pregnancy — their female partners do. Thus it becomes more difficult, ethically, to justify the side effects of hormonal contraceptives in men.
Previous Dish on the male pill here.
(Photo by Flickr user AndreaLaurel)
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