Re-Analyzing Phase III Bremelanotide Trials for "Hypoactive Sexual Desire Disorder" in Women
Spielmans GI. Journal of Sex Research 2021;58:1085-1105.
What it found
Using FDA application data, the author found benefits similar to those published, but reported that most outcomes listed in the trial protocols were not reported, that the odds of dropping out due to side effects were much higher on bremelanotide (odds ratio about 12), and that participants on placebo were more likely to complete the trial and enter the extension. The author concluded the drug is generally not useful.
Limitations
A single-author re-analysis. The original trial authors published a rebuttal. Its conclusions are a judgement about clinical meaning, not new trial data.
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