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A Comparison of Side Effects in Hypogonadal Men Treated With Natesto Versus Testosterone Injections

NCT04439799 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2023-12-13

Study results available
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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.

Conditions

  • Hypogonadism, Male

Interventions

DRUG

Testosterone Cypionate 200 Mg/ML

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

DRUG

Intranasal Testosterone

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,

Sponsors & Collaborators

  • Acerus Pharmaceuticals Corporation

    collaborator INDUSTRY

  • University of Miami

    lead OTHER

Principal Investigators

  • Ranjith Ramasamy, MD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-07
Primary Completion
2023-02-09
Completion
2023-02-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04439799 on ClinicalTrials.gov