A generally cautious and informative piece, but this story didn’t quite measure up on several key benchmarks, including the explanation of benefits and harms, and the evidence quality evaluation. Importantly, the story should have asked why nearly half of the study participants weren’t included the final data analysis, instead of pretending that they were never part of the study to begin with.
As the story suggests, many men would like alternatives for taking control of their fertility. Current options have important drawbacks, such as not always being available in the heat of the moment (e.g. condoms) or being invasive and potentially irreversible (e.g. vasectomy).
It’s probably too early to know what this treatment would cost were it commercially available, so we’ll rate this not applicable.
Like many early stage drug studies, the study looked for surrogate markers (sperm count and motility) rather than ability to fertilize. The distinction is not subtle. The true test of the combination gel will be in the rates of unintended pregnancies. The story explains what percentage of men in each group had undetectable levels of sperm or levels that were below a cutoff level defined by the investigators. However, to be of value to readers, the story would need to give some sense as to how this result would affect pregnancy rates. Although the story says that the treatment would have the effect of “lowering, but not eliminating, unwanted pregnancies,” this isn’t really specific enough. People want to know that a contraceptive will be close to 100% effective, or else it’s not worth taking. The story should have asked someone — either a study researcher or the independent source — whether the effects seen in the study are likely to be consistent with that standard.
The story also missed an opportunity to explain what is new and potentially better about the hormone gel tested in this study compared with similar treatments delivered by injection or implant. The benefit is that the gel could potentially be applied by men at home as opposed to needing a health professional to administer it in the office.
The story mentions acne as one of the problems seen with men taking the hormone gel, adding that we “just don’t know” what the long-term side effects might be.
While this comes close to meeting the standard, there are actually quite a few other known risks (some quite serious) associated with the administration of testosterone, which is one of the two hormones contained in the test gel. As the Mayo Clinic website explains, testosterone therapy may:
The story should have mentioned some of these risks.
The overall tone of the piece was cautious and there were some caveats about the evidence:
However, there was an important misstatement of fact in the piece which will affect readers’ interpretation of the findings. The story states that the study “involved 56 men who were assigned to receive one of three types of gels.” In fact, according to an Endocrine Society press release, there were originally 99 men assigned to treatment with the gel, but only fifty-six men completed at least 20 weeks of treatment and adhered to the study protocol. That 43% of the subjects either dropped out of the study or didn’t adhere to the protocol raises important questions about the viability of this approach to contraception. Unfortunately, the story didn’t explore these questions.
Providing alternative contraception options for men is an important issue, as the story suggests.
We’re going to take a hard line on this criterion. The comments from the one independent source appear to be confined to potential for men using a contraceptive and not to the study or the results and their implications. So, while there is an independent source, the comments were not relevant to the study per se. SInce surrogate measures were sought as an outcome measure, the comments of an independent expert related to the study results would have been informative.
The story mentions condoms and vasectomy as the other contraception options for men. It would have been nice to see some data on how effective these are at preventing unwanted pregnancy and a comparison with the gel tested here.
The story states: “The combination contraceptive needs to undergo further testing before it is commercially available.”
The story mentions previous research involving this combination of hormones for contraception.
The story wasn’t based on a press release. Rather, we wonder if it was based primarily on a 335 word abstract published on the Endocrine Society’s website.