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Androgen Replacement Therapy

Natesto vs Testosterone Injections for Low Testosterone

Phase 4
Waitlist Available
Led By Ranjith Ramasamy, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Documented diagnosis of primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired).
Naïve to androgen replacement or has discontinued current treatment and completed a washout of 4 months following androgen treatment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 4 months
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Study Summary

This trial is testing whether a higher dose of testosterone given less often is as effective as a lower dose given more often, and whether either has side effects.

Eligible Conditions
  • Testicular Hypogonadism

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have been diagnosed with a condition that affects the function of your reproductive glands.
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You have not started or stopped taking androgen replacement therapy for at least 4 months.
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Men who may need testosterone replacement therapy based on their medical history, physical exam, lab tests, and ECG.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Hematocrit (Hct) Levels.
Secondary outcome measures
Change in Estradiol Levels
Change in Hormone Levels
Change in PSA Levels
+1 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Group I: Testosterone Cypionate GroupActive Control1 Intervention
Participants in this group will receive the intramuscular Testosterone Cypionate intervention for four months
Group II: Natesto GroupActive Control1 Intervention
Participants in this group will receive the intranasal testosterone (Natesto) intervention for four months.

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
890 Previous Clinical Trials
408,464 Total Patients Enrolled
1 Trials studying Testicular Hypogonadism
60 Patients Enrolled for Testicular Hypogonadism
Acerus Pharmaceuticals CorporationIndustry Sponsor
12 Previous Clinical Trials
1,089 Total Patients Enrolled
2 Trials studying Testicular Hypogonadism
366 Patients Enrolled for Testicular Hypogonadism
Ranjith Ramasamy, MDPrincipal Investigator - University of Miami
Univ of Miami Hosp & Clinics-Sylvester Comp Cancer Center, University of Miami Hospital
12 Previous Clinical Trials
846 Total Patients Enrolled
1 Trials studying Testicular Hypogonadism
60 Patients Enrolled for Testicular Hypogonadism

Media Library

Intranasal Testosterone (Androgen Replacement Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04439799 — Phase 4
Testicular Hypogonadism Research Study Groups: Testosterone Cypionate Group, Natesto Group
Testicular Hypogonadism Clinical Trial 2023: Intranasal Testosterone Highlights & Side Effects. Trial Name: NCT04439799 — Phase 4
Intranasal Testosterone (Androgen Replacement Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04439799 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What health conditions can Natesto Group be utilized to treat?

"Natesto Group is a viable solution for treating vanishing testis syndrome, testicular hypogonadism and breast-related issues."

Answered by AI

Is there any evidence of prior research involving Natesto Group?

"Currently, 32 clinical trials are investigating the effectiveness of Natesto Group with 5 in their final stage. Although most studies take place in Houston, Texas; 134 sites across the US are offering this medication as part of a trial."

Answered by AI

Is this research project currently accepting participants?

"As per the data available on clinicaltrials.gov, this trial has ceased recruitment of participants. It was first posted on August 7th 2020 and last updated October 17th 2022; however, there are 67 other trials that are seeking patients as we speak."

Answered by AI

Could I qualify to partake in this experiment?

"Those who wish to join this medical trial must be between the ages of 18 and 75, in addition to having a diagnosis of hypogonadism. Approximately 200 patients need to be recruited for the study."

Answered by AI

Do the eligibility requirements for participation in this trial include individuals of advanced age?

"This trial is open to participants aged 18-75. Subcategories of the study have been allocated for those under 18, as well as a separate cohort of over 65s totalling 42 individuals."

Answered by AI

What is the approximate number of participants involved in this clinical trial?

"Currently, this research project is not actively accepting participants. It was originally published on August 7th 2020 and updated most recently on October 17th 2022. For those seeking an alternative trial, there are 35 clinical trials for hypogonadism currently enrolling patients, as well as 32 Natesto Group studies looking for volunteers."

Answered by AI

Has the Natesto Group been officially sanctioned by the FDA?

"Natesto Group's safety has been ascertained though a Phase 4 trial, which makes it eligible for approval. Consequently, there is strong evidence of the medication's security and our team at Power rated its safety with 3 out of 3 on their scale."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
University of Miami Miller School of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
~18 spots leftby Feb 2025