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Androgen Replacement Therapy

Androderm® 4 mg for Low Testosterone

Phase 4
Waitlist Available
Research Sponsored by Allergan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and week 16
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will study the effect of a daily dose of Androderm on blood pressure in men with low levels of testosterone.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 16 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline in 24-hour Average Systolic Blood Pressure (SBP) Obtained at Week 16
Secondary study objectives
Change From Baseline in 24-hour Average Diastolic Blood Pressure (DBP) Obtained at Week 16
Change From Baseline in 24-hour Average Heart Rate Obtained at Week 16
Change From Baseline in 24-hour Average Mean Arterial Pressure (MAP) Obtained at Week 16
+1 more

Side effects data

From 2021 Phase 4 trial • 168 Patients • NCT04320745
10%
APPLICATION SITE ERYTHEMA
8%
APPLICATION SITE RASH
1%
BRADYCARDIA
1%
COVID-19 PNEUMONIA
1%
FALL
1%
SYNCOPE
100%
80%
60%
40%
20%
0%
Study treatment Arm
Androderm® 4 mg

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

1Treatment groups
Experimental Treatment
Group I: Androderm® 4 mgExperimental Treatment1 Intervention
Participants received Androderm® 4 mg, transdermal dose, once daily (QD) for up to 16 weeks. At Day 14, if serum concentration was less than 400 nanograms per deciliter (ng/dL), the dose was increased to 6 mg, transdermal dose, QD for up to 16 weeks and if the serum concentration was more than 930 ng/dL, the dose was decreased to 2 mg, transdermal dose, QD for up to 16 weeks. The dose was not adjusted if serum concentrations were within the normal range.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Androderm®
2020
Completed Phase 4
~170

Find a Location

Who is running the clinical trial?

AllerganLead Sponsor
781 Previous Clinical Trials
276,486 Total Patients Enrolled
Anna ChanStudy DirectorAllergan
12 Previous Clinical Trials
972 Total Patients Enrolled
~31 spots leftby Oct 2025
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