Pharmacokinetics of Testosterone Cream Applied to Scrotal Skin in healthy male volunteers
Andrology Department, Concord Hospital
12 participants
Jun 4, 2015
Interventional
Conditions
Summary
The Pharmacokinetics of Testosterone Cream Applied to Scrotal Skin study is a dose finding study to determine the effectiveness of absorption of testosterone cream when applied in an alternative way to current practice. Long-term compliance with testosterone replacement therapy requires convenience in the delivery system to facilitate continuation of treatment with minimal intrusion or disruption to daily life. Current product information for transdermal( via the skin) application of testosterone states it is not to be administered to the genital area. Transdermal application of testosterone depends on the stratum corneum, the layers of dead skin cells which limit permeability of small molecules through the skin. Skin varies widely in thickness and steroidal (cortisol) permeability. The thinnest stratum corneum and highest steroidal permeability is scrotal skin. The study will determine the absorption rate of testosterone cream when applied to scrotal skin. The study will be conducted at the Department of Andrology, CRGH and will aim to recruit 12 healthy male volunteers from the local community. Eligible and consenting participants will visit the study centre 5 times. The men will receive 2 separate intramuscular injection of nandrolone decanoate to temporarily suppress testosterone levels. They will self-administer 3 dose applications (in random order) of testosterone cream to their scrotal skin. Venous and capillary dried blood spots will be collected before and over a 24 hour period before and after application of the cream to monitor hormone levels.
Eligibility
Inclusion Criteria3
- 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
Exclusion Criteria4
- 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.
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Interventions
Healthy volunteers will visit the study centre 5 times. 2 separate injections of Nandrolone Decanoate will be given to temporarily suppress testosterone levels of healthy male volunteers. These healthy volunteers will be administered an intramuscular injection of 200mgs of Nandrolone Decanoate 3 days prior to and 100mgs 4 days after the first testosterone cream dose. At the study centre, 3 doses (12.5mgs; 25mgs; 50mgs) of Testosterone Cream will be self-administered by healthy volunteers on 3 separate occasions to scrotal skin. 3 days after the first Nandrolone Decanoate injection the healthy volunteer will wear a disposable latex glove to self-administer the first random dose of testosterone cream. Blood samples will be taken every hour for 12 hours followed by second hourly for 4 hours. The healthy volunteer will then go home where he will collect a drop of blood onto blotting paper 24 hours after his dose of testosterone cream. This regime will be repeated for the 2 other random Testosterone Cream doses. There will be at least 2 days washout period between each subsequent dose of testosterone cream. The healthy volunteer will be at the study centre for approximately 16 hours of monitoring after each random dose of Testosterone Cream.
Locations(1)
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ACTRN12615000045516