None listed
Conditions
Brief summary
This research study looks into new ways to detect the use of low doses of testosterone for doping in women. The lure of fame and fortune through competitive success in elite sports will always tempt some athletes to cheat including by doping using performance enhancing drugs. At present, testosterone is known to be illegally among to enhance athletic performance. Testosterone is the most powerful and widely used in doping to gain unfair advantages in athletic performance. Anti-doping detection tests, based on urine samples are used to detect, deter and penalise cheating athletes who use testosterone in elite athletics or training. However, it is not clear how quick to detect these tests are especially for women and there is a concern that low doses of testosterone may be missed by the standard urine tests. This study is designed to address this important gap in knowledge in anti-doping science as well as aiming to develop better, more responsive tests. This study is for the first time studying in detail the use of blood tests to see how well they add to and improve on the standard urine tests to detect use of testosterone.
Interventions
Testosterone gel treatment 12.5 mg per day (one actuation of the gel pump) for 7 days.
Participants will receive verbal and visual instructions on the application process at the commencement of the treatment phase. They will be instructed to apply testosterone gel after a morning shower, cover the area with clothes, wash their hands thoroughly afterwards and not to be in any skin contact with other person's skin until washing their hands for at least six hours to avoid transferring any gel to th
Testosterone gel treatment 12.5 mg per day (one actuation of the gel pump) for 7 days. Participants will receive verbal and visual instructions on the application process at the commencement of the treatment phase. They will be instructed to apply testosterone gel after a morning shower, cover the area with clothes, wash their hands thoroughly afterwards and not to be in any skin contact with other person's skin until washing their hands for at least six hours to avoid transferring any gel to them. The Testosterone gel bottles will be weighed prior to and at the completion of seven days of treatment when they return the remaining of the unused gel bottle. Participants will also be made aware of this.
Sponsors
Sydney Local Health District
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
• Healthy women aged between 18 and 60 years • Provide written, informed consent and willing to comply with all study requirements
Exclusion criteria
• Pregnancy, breast feeding or seeking fertility within next 6 months • Using hormonal drugs other than oral contraception (eg estrogen replacement) • Athletes subject to regular urine drug testing • Contraindication to testosterone (breast cancer, polycythemia) • Major, serious or chronic medical disorders including chronic viral (HIV, hepatitis) infection that require regular prescribed medication • Severe or extensive skin disease that interferes with transdermal drug delivery • Regular medications that interfere with dermal absorption or metabolism of testosterone • History of androgen or other drug abuse within last year • History of major psychiatric disease or psychological condition that may limit understanding and compliance with study requirements in the investigator’s opinion
Outcome results
None listed