To Determine the Effects of Deodorant, Antiperspirant and Washing on the Pharmacokinetics of 2% Testosterone MD Lotion (MTE10)

Acrux DDS

Status and phase: Completed; Phase 1

Conditions: Hypogonadism

Treatments: Drug: Testosterone MD-Lotion

Study type: Interventional

Funder types: Industry

Identifiers

NCT00857168

MTE10

Details and patient eligibility

About

Testosterone replacement treatment is the most effective way of treating hypogonadism in men.

Acrux has a propriety testosterone replacement product, Testosterone MD-Lotion and this study will evaluate the impact of application of antiperspirant and deodorant on absorption of testosterone, when applied pre-application of Testosterone MD-Lotion® (cutaneous solution).

The study also aim to evaluate the impact of washing the application site on the absorption of testosterone, when washed post-application of Testosterone MD-Lotion® (cutaneous solution).

Enrollment: 36 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy premenopausal female subjects ≥18 and ≤45 years of age with qualifying general medical health.

Exclusion criteria

• Disqualifying concurrent condition or allergy/sensitivity to testosterone replacement therapy.

Trial design

36 participants in 6 patient groups

Group 1

Active Comparator group

Treatment:

Drug: Testosterone MD-Lotion

Group 2

Active Comparator group

Treatment:

Drug: Testosterone MD-Lotion

Group 3

Active Comparator group

Treatment:

Drug: Testosterone MD-Lotion

Group 4

Active Comparator group

Treatment:

Drug: Testosterone MD-Lotion

Group 5

Active Comparator group

Treatment:

Drug: Testosterone MD-Lotion

Group 6

Active Comparator group

Treatment:

Drug: Testosterone MD-Lotion