A Study to Evaluate the Potential for Interpersonal Transfer of Testosterone Following Single Dose Application

Hypogonadism Clinical Trial

Official title:

A Phase I Study to Evaluate the Potential for Interpersonal Transfer of Testosterone Following Single Dose Application of 2% Testosterone Metered Dose (MD) Lotion®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01172366
• Other study ID #: MTE12
• Status: Completed
• Phase: N/A
• First received: July 28, 2010
• Last updated: September 2, 2010
• Start date: August 2010
• Est. completion date: September 2010

Study information

• Verified date: August 2010
• Source: Acrux DDS Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Observational

Clinical Trial Summary

The hypotheses for this study is that there is no transfer of testosterone from male (donor) subjects to female (recipient) subjects when contact is made 2 hours post application of 2% Testosterone MD-Lotion® if the donor has a covered application area with a T-shirt.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Healthy Male Subjects:

Inclusion:

• Healthy male subjects aged = 18 and = 45, who have no history of clinically significant medical disorders and who have passed the required laboratory and physical screening tests.

Exclusion:

• Men with a history of allergy/sensitivity to testosterone or in whom testosterone therapy is contraindicated, or a clinically significant finding on physical exam or skin disorder.

Healthy Female Subjects:

Inclusion:

• Healthy premenopausal women aged = 18 and = 45, who have no history of clinically significant medical disorders and who have passed the required laboratory and physical screening tests.

Exclusion:

• Women with a history of allergy/sensitivity to testosterone or in whom testosterone therapy is contraindicated, or a clinically significant finding on physical exam or skin disorder.

Study Design

N/A

Related Conditions & MeSH terms

• Hypogonadism

Locations

Country	Name	City	State
Australia	QPharm	Brisbane	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Acrux DDS Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics	Single dose pharmacokinetic parameters (AUC0-24, AUC0-72, Cmin, Cmax, and tmax) are to be reported for total testosterone, free testosterone and DHT.	72 hours total	No