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

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ClinicalTrials.gov Identifier: NCT01172366
Recruitment Status : Completed
First Posted : July 29, 2010
Last Update Posted : September 6, 2010
Sponsor:
Information provided by:
Acrux DDS Pty Ltd

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.

Condition or disease
Hypogonadism

Study Type : Observational
Estimated Enrollment : 20 participants
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®
Study Start Date : August 2010
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Pharmacokinetics [ Time Frame: 72 hours total ]
    Single dose pharmacokinetic parameters (AUC0-24, AUC0-72, Cmin, Cmax, and tmax) are to be reported for total testosterone, free testosterone and DHT.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Director, Clinical Development, Acrux DDS Pty Ltd
ClinicalTrials.gov Identifier: NCT01172366     History of Changes
Other Study ID Numbers: MTE12
First Posted: July 29, 2010    Key Record Dates
Last Update Posted: September 6, 2010
Last Verified: August 2010

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
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents