CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 105 enrolled
Drug / intervention
Testosterone Cypionatedrug
Likely dose
Testosterone Cypionate 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01378299
NCT01378299Phase 1Completed

CYP19A1 Gene and Pharmacogenetics of Response

VA Office of Research and Development·interventional·Posted Jun 22, 2011·Updated Mar 5, 2019

In Brief

A Phase 1 clinical trial evaluating Testosterone Cypionate for Hypogonadism. Completed, enrolled 105 participants across 2 sites.

Detailed Summary

Testosterone (T) replacement prevents bone loss and relieves symptoms associated with androgen deficiency in male patients with hypogonadism, but at the expense of an increase in prostate-related adverse events and in the hematocrit values above the normal which may lead to bad circulatory outcomes. Most of the effects of T on the male skeleton are mediated by its conversion to estradiol (E2) by the enzyme aromatase. Genetic variations in the aromatase (CYP19A1) gene result in enzymes with variable activity and variable levels of E2 and T. This project is designed to determine if genetic variations in the CYP19A1 gene will result in differences in the skeletal response and incidence of side effects from T treatment in patients with low T. A large number of male Veterans are on T. Results from this project will help identify patients who would benefit from the therapy from those at risk for side effects, and would definitely have an impact in the future care of these patients and male patients in general once genetic profiling becomes part of the standard of care.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypogonadism
CountriesUnited States

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 22, 2011
Enrollment StartOct 1, 2011
Primary CompletionNov 7, 2016
Study CompletionNov 7, 2017
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 15.0 years ago

Interventions

Testosterone Cypionatedrug

Testosterone cypionate was administered at 200 mg by intramuscular injection every 2 weeks. DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for testosterone cypionate is androst-4-en-3-one,17-(3-cyclopentyl-1oxopropoxy)-, (178)-. Its molecular formula is CvH400a, and the molecular weight of 412.61.