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

NCT01172366 | Completed

• 1 other identifier: MTE12
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypogonadism

Keywords

Open label, single dose, pharmacokinetic study

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy male and female volunteers

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.
• 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.

Sponsors & Collaborators

• Acrux DDS Pty Ltd: lead

Study Sites (1)

QPharm

Brisbane, Queensland, Australia

Location

MeSH Terms

Conditions

Hypogonadism

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Study Officials

• Tina Soulis, BSc, PhD

  Acrux DDS Pty Ltd

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 28, 2010
• First Posted: July 29, 2010
• Study Start: August 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: September 6, 2010

Record last verified: 2010-08

Locations

AU (1)