Natesto Group for Hypogonadism

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Hypogonadism+2 More
Testosterone Cypionate 200 MG/ML - Drug
Eligibility
18+
Male
What conditions do you have?
Select

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
  • Hypogonadism

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Other trials for Hypogonadism

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: Baseline, 4 months

Baseline, 4 months
8. Change in SF-15 Erectile Function Domain Scores
Change in Hematocrit (Hct) levels.
Change in PSA levels
Change in SF-15 Intercourse Satisfaction Domain Scores
Change in SF-15 Questionnaire Scores
Change in estrogen levels
Change in gonadotropin levels
Body Weight Changes
Changes in IIEF score
baseline, 4 months
Change in Testicular Volume

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Hypogonadism

Trial Design

2 Treatment Groups

Natesto Group
1 of 2
Testosterone Cypionate Group
1 of 2
Active Control

200 Total Participants · 2 Treatment Groups

Primary Treatment: Natesto Group · No Placebo Group · Phase 4

Natesto Group
Drug
ActiveComparator Group · 1 Intervention: Intranasal Testosterone · Intervention Types: Drug
Testosterone Cypionate Group
Drug
ActiveComparator Group · 1 Intervention: Testosterone Cypionate 200 MG/ML · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 4 months

Who is running the clinical trial?

Acerus Pharmaceuticals CorporationIndustry Sponsor
12 Previous Clinical Trials
1,139 Total Patients Enrolled
8 Trials studying Hypogonadism
812 Patients Enrolled for Hypogonadism
University of MiamiLead Sponsor
787 Previous Clinical Trials
384,210 Total Patients Enrolled
2 Trials studying Hypogonadism
180 Patients Enrolled for Hypogonadism
Ranjith Ramasamy, MDPrincipal Investigator - University of Miami
Univ of Miami Hosp & Clinics-Sylvester Comp Cancer Center, University of Miami Hospital
11 Previous Clinical Trials
1,067 Total Patients Enrolled
2 Trials studying Hypogonadism
180 Patients Enrolled for Hypogonadism

Eligibility Criteria

Age 18+ · Male Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Based on the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG), men are deemed to be candidates for TRT.
This means that the person's testosterone levels are below 300 ng/dL on two separate measurements.
The person is new to androgen replacement therapy or has stopped their current treatment and waited 4 months before starting androgen replacement therapy.
Consent forms have been approved by an Institutional Review Board
The individual has a documented diagnosis of primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 3rd, 2021

Last Reviewed: October 2nd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Florida100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
University of Miami Miller School of Medicine100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References