Pharmacokinetics of Testosterone Lotion in the Treatment of Hypogonadal Males

A Phase II Randomised, Two-Way Crossover Study to Compare the Steady State Pharmacokinetics of Testosterone Following Application of Different Testosterone Metered-Dose (MD) Lotion Doses in Hypogonadal Male Subjects

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00372008

Enrollment

Registered

2006-09-06

Start date

2006-10-31

Completion date

2007-04-30

Last updated

2008-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypogonadism

Brief summary

Testosterone replacement treatment is the most effective way of treating hypogonadism in men. Acrux has a proprietry testosterone replacement product - Testosterone-MD Lotion, and this study will evaluate the efficacy and safety of this product.

Interventions

DRUGTestosterone

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Hypogonadal males between 18-70 years old with qualifying general medical health

Exclusion criteria

* Disqualifying concurrent conditions or allergy/sensitivity to testosterone replacement therapy

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic	—

Secondary

Measure	Time frame
Safety and tolerability	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026