A Bioequivalence Study of Testosterone Cypionate in Hypogonadal Males

Status Completed

Clinical Trial Summary

This is an open-label, 2-treatment, 2-period, single dose (200 mg, IM) cross-over study, 2-part design to evaluate the bioequivalence (BE) of a reformulated presentation (test) of testosterone cypionate solution for injection relative to the currently approved marked formulation (reference). In the first part of the study (Part 1), an estimate of the exposure variability will be evaluated for both test and reference. This will help guide sample size in Part 2. Part 2 will be powered to assess the BE of both test and reference formulations.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Hypogonadism

Clinical Trial Details

NCT number	NCT03792477
Study type	Interventional
Source	Pfizer
Contact
Status	Completed
Phase	Phase 1
Start date	January 19, 2019
Completion date	April 2, 2020

View Details

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