> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Guide on Hypogonadotropic Hypogonadism Drugs
- URL: https://www.fdaweb.com/guide-on-hypogonadotropic-hypogonadism-drugs/
- Published: 2018-05-18T12:00:00.000Z
- Updated: 2026-09-15T00:06:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141474

FDA has posted a [guidance](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM590887.pdf?ref=fdaweb.com) on “Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hypogonadism Attributed to Nonstructural Disorders.” The document provides recommendations for establishing clinical effectiveness for such drugs that do not cause structural disorders of the hypothalamus or pituitary gland. The drugs should both increase serum testosterone concentrations and improve how patients feel, function, or survive, according to the agency. The guidance includes advice FDA received at a 12/2014 advisory committee meeting on the appropriate indicated population for testosterone therapy, and a 12/2016 advisory committee meeting on hypogonadotropic hypogonadism.