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I read that there was a phase three clinical trial for Enclomiphene and the FDA didn't approve it, why is that?
I read that there was a phase three clinical trial for Enclomiphene and the FDA didn't approve it, why is that?
Alex avatar
Written by Alex
Updated over a week ago

The FDA has approved clomiphene citrate (Clomid) as a fertility drug. It has been used off-label for hormone optimization safely & effectively for decades, and enclomiphene as an isomer can be legally prescribed since it is a component of an FDA-approved drug.

A review paper concluded: “enclomiphene is a very promising drug for patients with secondary hypogonadism and who are concerned about the negative effects of exogenous testosterone. Despite the fact that there was clearly demonstrated efficacy without any substantial safety issues. The lack of clearly demonstrated symptomatic improvement in phase III studies prevented enclomiphene from obtaining FDA approval [due to the inherent]… difficulty of demonstrating a symptomatic benefit for secondary hypogonadism.” https://pubmed.ncbi.nlm.nih.gov/31063005/

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