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

This study has been completed.
Sponsor:
Information provided by:
Acrux DDS Pty Ltd
ClinicalTrials.gov Identifier:
NCT01172366
First received: July 28, 2010
Last updated: September 2, 2010
Last verified: August 2010
History of Changes
  Purpose

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.


Condition
Hypogonadism

Study Type: Observational
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®

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Acrux DDS Pty Ltd:

Primary Outcome Measures:
  • Pharmacokinetics [ Time Frame: 72 hours total ] [ Designated as safety issue: No ]
    Single dose pharmacokinetic parameters (AUC0-24, AUC0-72, Cmin, Cmax, and tmax) are to be reported for total testosterone, free testosterone and DHT.


Estimated Enrollment: 20
Study Start Date: August 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy male and female volunteers

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01172366

Locations
Australia, Queensland
QPharm
Brisbane, Queensland, Australia
Sponsors and Collaborators
Acrux DDS Pty Ltd
Investigators
Study Director: Tina Soulis, BSc, PhD Acrux DDS Pty Ltd
  More Information

No publications provided

Responsible Party: Director, Clinical Development, Acrux DDS Pty Ltd
ClinicalTrials.gov Identifier: NCT01172366     History of Changes
Other Study ID Numbers: MTE12
Study First Received: July 28, 2010
Last Updated: September 2, 2010
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Acrux DDS Pty Ltd:
Open label, single dose, pharmacokinetic study

Additional relevant MeSH terms:
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on May 21, 2013