Pharmacokinetics of Testosterone Cream Applied to Scrotal Skin in healthy male volunteers
- Conditions
- Healthy male volunteers - dose finding - testosterone pharmacologyOther - Research that is not of generic health relevance and not applicable to specific health categories listed above
- Registration Number
- ACTRN12615000045516
- Lead Sponsor
- Andrology Department, Concord Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 12
Healthy male volunteers aged greater than or equal to 18 years of age to less than or equal to 50 years of age
Able to personally read and understand the study Participant Information and Consent Form and provide written, signed and dated informed consent to participate in study.
Able to comply with all study procedures and visits
No serious chronic medical illness requiring regular prescribed medication.
No contraindications to testosterone including prostate or breast cancer, untreated sleep apnoea or polycythaemia.
No history of major psychiatric disease or psychological condition that may limit understanding and compliance with study requirements.
No regular use of medications that interfere with dermal absorption or metabolism of testosterone.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetics of testosterone of 3 different, single dose applications to scrotal skin with serum testosterone measured by liquid chromatography mass spectrometry and pharmacokinetics parameters estimated by standard pharmacological analysis - Tmax, Cmax and Area Under the Curve[24 hour sampling <br>venous bloods at -15, -5 minutes; random testosterone dose applied; venous bloods continue at 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 hours plus venous blood spot at 0, 4, 8, 12, 16 hours and at 24 hours by finger-prick]
- Secondary Outcome Measures
Name Time Method