CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 81 enrolled
Drug / intervention
Testosterone Cypionate 200 Mg/ML +1 moredrug
Likely dose
Testosterone Cypionate 200 Mg/MLfrom 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/NCT04439799
NCT04439799Phase 4Completed
CompareCT.gov

A Comparison of Side Effects in Hypogonadal Men Treated With Natesto Versus Testosterone Injections: A Phase IV, Prospective, Randomized, Non-Blinded, Multi-Institutional Study

University of Miami·interventional·Posted Jun 19, 2020·Updated Dec 13, 2023

In Brief

A Phase 4 clinical trial evaluating Testosterone Cypionate 200 Mg/ML and Intranasal Testosterone for Hypogonadism, Male. Completed, enrolled 81 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate changes in vascular parameters and the prevalence of side effects in subjects receiving 1 cc (200mg) every 2 weeks intramuscular (IM) of Testosterone Cypionate versus subjects receiving 11mg three times daily (TID) Natesto to participant with clinical hypogonadism.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypogonadism, Male
CountriesUnited States
CollaboratorsAcerus Pharmaceuticals Corporation

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedJun 19, 2020
Enrollment StartAug 7, 2020
Primary CompletionFeb 9, 2023
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 6.0 years ago

Interventions

Testosterone Cypionate 200 Mg/MLdrug

Participants in this group will receive intramuscular testosterone cypionate injections of 1 cc (200mg) once every 14 days for four months.

Intranasal Testosteronedrug

Participant in this group will receive Intranasal testosterone administered using a multi-dose dispenser, as two or three daily doses (5.5 mg per nostril, 11.0 mg single dose) for 4 consecutive months,