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# Testicular Toxicity Draft Guidance
- URL: https://www.fdaweb.com/testicular-toxicity-draft-guidance/
- Published: 2018-10-24T12:00:00.000Z
- Updated: 2026-09-15T00:40:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142666

FDA has issued a draft guidance, *Testicular Toxicity: Evaluation During Drug Development*, to assist sponsors who are developing drug products that may have potential adverse effects on the testes, referred to by FDA as testicular toxicity, based on findings in non-clinical studies. The [document](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM455102.pdf?ref=fdaweb.com) discusses: 

- non-clinical findings that suggest risk of clinical testicular toxicity, and further non-clinical assessments that may be necessary to evaluate the extent of the risk;
- clinical monitoring that can be employed when the drug products are initially administered to men; and
- the design of a clinical trial that has as its primary purpose the evaluation of drug-related testicular toxicity.

The guidance provides general considerations for when clinical trials to assess the risk of testicular toxicity may be needed, but does not cover all possible scenarios that would prompt such a trial. It also does not discuss regulatory actions that the agency might consider based on the trial results.