Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000633189
Ethics application status
Approved
Date submitted
11/04/2019
Date registered
29/04/2019
Date last updated
22/04/2020
Date data sharing statement initially provided
29/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Detection of Testosterone Microdosing in Women
Scientific title
Detection of Testosterone Microdosing in Women
Secondary ID [1] 297952 0
None
Universal Trial Number (UTN)
U1111-1231-5684
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Doping in sports. 312352 0
Condition category
Condition code
Metabolic and Endocrine 310912 310912 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 314175 0
Treatment: Drugs
Comparator / control treatment
No comparator or control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319840 0
Exploratory urine steroid profile including carbon isotope ratio of testosterone and its 5a reduced metabolites as assessed by GC-MS
Timepoint [1] 319840 0
Before treatment visits (5 day visits within 2 weeks, no set days) will be scheduled over at least two weeks, Followed by 7 more visits on day 0, 7, 8,9,11,14 and 21 post treatment phase.
Primary outcome [2] 319841 0
Exploratory blood steroid profile including serum testosterone as assessed by LC-MS
Timepoint [2] 319841 0
Before treatment visits (5 day visits within 2 weeks, no set days) will be scheduled over at least two weeks, Followed by 7 more visits on day 0, 7, 8,9,11,14 and 21 post treatment phase.
Secondary outcome [1] 369654 0
Exploratory blood profile including hemoglobin and reticulocytes as assessed by autoanalyser
Timepoint [1] 369654 0
Before treatment visits (5 day visits within 2 weeks, no set days) will be scheduled over at least two weeks, Followed by 7 more visits on day 0, 7, 8,9,11,14 and 21 post treatment phase.
Secondary outcome [2] 369761 0
UGT2B17 genotype bypolymerase chain reaction (PCR)
Timepoint [2] 369761 0
At baseline visit

Eligibility
Key inclusion criteria
• Healthy women aged between 18 and 60 years
• Provide written, informed consent and willing to comply with all study requirements
Minimum age
18 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis
Mixed model linear analysis with serial repeated measurements of serum and urine steroids and hematological profile before, during and after testosterone treatment with age and body weight (or BMI) as covariates.
For analytes where there is a significant difference from baseline, linear discriminant analysis and receiver-operated curve (ROC) analysis will be used to define the optimal cutpoint (Youden’s index) for individual and combined parameters to detect testosterone administration as well as the window of detection during run-off.
The findings will also be analyzed with ABP software for steroidal and hematological modules.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2019
Actual
6/05/2019
Date of last participant enrolment
Anticipated
1/04/2020
Actual
2/10/2019
Date of last data collection
Anticipated
1/06/2020
Actual
18/11/2019
Sample size
Target
12
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 13611 0
Concord Repatriation Hospital - Concord
Recruitment postcode(s) [1] 26273 0
2139 - Concord

Funding & Sponsors
Funding source category [1] 302520 0
Charities/Societies/Foundations
Name [1] 302520 0
Partnership for Clean Competition (USA)
Country [1] 302520 0
United States of America
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
Level 11, KGV Building
Missenden Road
CAMPERDOWN NSW 2050
Country
Australia
Secondary sponsor category [1] 302426 0
None
Name [1] 302426 0
Address [1] 302426 0
Country [1] 302426 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303135 0
Sydney Local Health District Human Research Ethics Committee-Concord Repatriation General Hospital
Ethics committee address [1] 303135 0
Ethics committee country [1] 303135 0
Australia
Date submitted for ethics approval [1] 303135 0
27/11/2018
Approval date [1] 303135 0
24/01/2019
Ethics approval number [1] 303135 0
CH62/6/2018-201 HREC/18/CRGH/295

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92594 0
Prof David Handelsman
Address 92594 0
Department of Andrology
Concord Repatriation General Hospital
Building 22
1A hospital Road
Concord 2139 NSW
Country 92594 0
Australia
Phone 92594 0
+61 2 97677222
Fax 92594 0
+61297677221
Email 92594 0
[email protected]
Contact person for public queries
Name 92595 0
David Handelsman
Address 92595 0
Department of Andrology
Concord Repatriation General Hospital
Building 22
1A Hospital Road
Concord 2139 NSW
Country 92595 0
Australia
Phone 92595 0
+61 297677222
Fax 92595 0
+61297677221
Email 92595 0
[email protected]
Contact person for scientific queries
Name 92596 0
David Handelsman
Address 92596 0
Department of Andrology
Concord Repatriation General Hospital
Building 22
1A hospital Road
Concord 2139 NSW
Country 92596 0
Australia
Phone 92596 0
+61 297677222
Fax 92596 0
+61297677221
Email 92596 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual identifiable participant data will not be shared with a third party.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1854Informed consent form    377384-(Uploaded-11-04-2019-15-24-00)-Study-related document.pdf
1857Study protocol    377384-(Uploaded-11-04-2019-15-25-25)-Study-related document.docx
1905Ethical approval    377384-(Uploaded-17-04-2019-14-29-15)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDetection of testosterone microdosing in healthy females.2022https://dx.doi.org/10.1002/dta.3202
Dimensions AIDried blood spot sampling of testosterone microdosing in healthy females2024https://doi.org/10.1016/j.jsbmb.2024.106496
N.B. These documents automatically identified may not have been verified by the study sponsor.