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Trial registered on ANZCTR
Registration number
ACTRN12611000042943
Ethics application status
Not yet submitted
Date submitted
12/01/2011
Date registered
12/01/2011
Date last updated
12/01/2011
Type of registration
Prospectively registered
Titles & IDs
Public title
Detection of Dehydroepiandrosterone (DHEA) Augmentation Doping: Pilot Study
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Scientific title
Open, non-randomized interventional study in healthy adult volunteers to obtain blood and urine samples for steroid analysis: To identify the serum and urine changes in the androgen profile in (a) men administered DHEA with and without pregnenolone and (b) women administered DHEA with and without anti-estrogens.
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Secondary ID [1]
253388
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HREC Ref No: HREC/10/CRGH/168
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
The effect of oral DHEA with and without other steroid precursors, as a sports doping agent on healthy adult males and females.
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Condition category
Condition code
Metabolic and Endocrine
258634
258634
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0
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Normal metabolism and endocrine development and function
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Following a brief screening visit, eligible, healthy, adult volunteers will be enrolled (4 male & 4 female) into the study.
Visit 1 (Friday)- baseline blood and urine samples will be taken and each participant will then be administered 100mg oral DHEA. They will also be provided with 100mg DHEA to take daily for the next 2 days.
Visit 2 (Monday)- prior to taking any study medication a blood and urine sample will be taken from each participant.
MEN will then be administered 100mg oral DHEA and 200mg oral Pregnenolone; and given 2 more days supply of each drug to take on the next 2 days (Tues & Wed).
WOMEN will be administered 100mg oral DHEA and 2.5mg oral Letrozole and will be provided with 2 more days supply of each drug to take on the next 2 days (Tues & Wed).
Visit 3 (Thursday) blood and urine samples will be taken from all participants.
Information will be collected regarding any adverse events, concomitant medications commenced during the study and blood will be taken for routine biochemistry and haematology as a safety measure.
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Intervention code [1]
257463
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Treatment: Drugs
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Comparator / control treatment
Participants will act as their own controls.
The aim of the study is to identify the serum and urine changes in the androgen profiles of volunteers after administration of DHEA with and without Pregnenolone ( in men) and with and without Letrozole (in women).
Blood and urine samples will be taken at baseline prior to any study medication, samples will be taken for comparison after 3 days of DHEA alone and again after 3 days of DHEA with pregnenolone (in men) or letrozole (in women).
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Control group
Active
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Outcomes
Primary outcome [1]
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Serum steroid profile will be assayed using the LC-tandem MS method in order to determine if the dosage and duration of treatment show significant effects.
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Assessment method [1]
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Timepoint [1]
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A single blood sample will be collected from each participant prior to drug administration at day 1 (baseline) day 3 and day 6.
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Primary outcome [2]
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Urine steroid profile will be measured after conjugation and deconjugation by GC-MS method in order to determine if the dosage and duration of treatment show significant effects.
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Assessment method [2]
259932
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Timepoint [2]
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A single urine sample will be collected from each participant prior to drug administration at day 1 (baseline) day 3 and day 6.
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Secondary outcome [1]
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Participant safety will be monitored by
1. screening to ensure good health prior to study enrolment and
2. routine biochemistry and haematology review at end of study.
Participants will be questioned at each visit about all adverse events occuring during the study period , and these will be recorded for medical review.
Side effects of DHEAreported in men includehair loss, weight gain, fatigue, headache, nasal congestion, acne, rapid/irregular heartbeat. DHEA in women has been reported to cause greasy skin, acne, hirsutism, mood changes and menstrual disturbance. However the short duration of treament (6 Dyas0 is unlikely to cause any serious side effects.
Pregnenolone may increase the risk of seizures in men with epilepsy; who are therefore excluded from this study.
Letrozole is given at the same dose as used in adjuvant treatment of women with breast cancer. prolonged use can result in flushing, arthralgia, gastrointestinal disturbances, headache and dizzyness, fqtigue and weight gain. Again the short duration of treament is unlikely to result in any prolonged or permanent side effects.
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Assessment method [1]
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Timepoint [1]
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Screening visit, days 1, 3 and 6
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Eligibility
Key inclusion criteria
Men: over 18, healthy
Women: over 18, healthy
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Men: chronic disease or requiring regular medical treatment, epilepsy, history of hormone dependant cancers (prostate) or recent (<3 month) use of hormonal drugs.
Women:pregnant, breasfeeding, chronic disease or requiring regular medical treatment, history of hormone dependant cancers or recent (<3 month) use of hormonal drugs.
Of child bearing potential and not using reliable form of contraception.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Those interested in taking part in response to local advertising will be asked a series of questions initially to establish their eligibility to participate.
A screening visit will be arranged, where the participant will sign an informed consent, a brief medical history recorded and bloods taken for biochemistry and haematology.
If sucessfully screened the participant will commence the open label study as soon as possible. Treatment is neither blinded nor randomly allocated.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Non randomised
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
Open, non-randomized interventional study in healthy volunteers to obtain blood and urine samples for steroid analysis
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Phase
Not Applicable
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Type of endpoint/s
Pharmacokinetics / pharmacodynamics
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/02/2011
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
8
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
258306
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Government body
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Name [1]
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United States Anti Doping Agency (USADA)
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Address [1]
258306
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5555Tech Centre Drive,
Suite 200
Colorado Springs< Colorado 80919-2372
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Country [1]
258306
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United States of America
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Primary sponsor type
Hospital
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Name
Sydney South West Area Health Authority (SSWAHS)
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Address
Concord Repatriation General Hospital
Conocrd NSW 2139
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
257471
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Other collaborator category [1]
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Other Collaborative groups
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Name [1]
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National Measurement Institute
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Address [1]
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Dr Catrin Goebel
Australian Sports Drug Testing Laboratory
National Measurement Institute
1 Suakin Street
Pymble
NSW 2073
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Country [1]
251769
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Australia
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
260295
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Concord Hospital, Human Research Ethics Committee (HREC)
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Ethics committee address [1]
260295
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Concord repatriation General Hospital,
Hospital Road, Concord
NSW 2139
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Ethics committee country [1]
260295
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Australia
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Date submitted for ethics approval [1]
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20/10/2010
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Approval date [1]
260295
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Ethics approval number [1]
260295
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HREC/10/CRGH/168
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Summary
Brief summary
Endogenous DHEA is banned for use in elite competitive sports, however its covert use in combination with other non banned steroid precursors (eg pregnenolone, letrozole) to increase testosterone levels is suspected.
This pilot study aims to identify the serum and urine changes in the androgen profile of healthy men (n=4) following the administration of DHEA with and without pregnenolone and in healthy women (n=4) following the administration of DHEA with and without letrozole.
We aim to test the hypotheses that these drug combinations will result in increased androgenic effects in both men and women; thus requiring improved detection methods to detect this DHEA augmentation doping in both serum and urine.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
31819
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Address
31819
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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D J Handelsman
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Address
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Anzac Research Institute
Hospital Road
Concord NSW 2139
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Country
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Australia
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Phone
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00612 9767 7222
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Fax
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00612 9767 7221
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Email
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[email protected]
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Contact person for scientific queries
Name
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D J Handelsman
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Address
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Anzac Research Institute
Hospital Road
Concord NSW 2139
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Country
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Australia
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Phone
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00612 9767 7222
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Fax
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00612 9767 7221
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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