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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
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.
Secondary ID [1] 253388 0
HREC Ref No: HREC/10/CRGH/168
Universal Trial Number (UTN)
Trial acronym
Linked study record

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. 260943 0
Condition category
Condition code
Metabolic and Endocrine 258634 258634 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 257463 0
Treatment: Drugs
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).
Control group
Active

Outcomes
Primary outcome [1] 259931 0
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.
Timepoint [1] 259931 0
A single blood sample will be collected from each participant prior to drug administration at day 1 (baseline) day 3 and day 6.
Primary outcome [2] 259932 0
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.
Timepoint [2] 259932 0
A single urine sample will be collected from each participant prior to drug administration at day 1 (baseline) day 3 and day 6.
Secondary outcome [1] 268837 0
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.
Timepoint [1] 268837 0
Screening visit, days 1, 3 and 6

Eligibility
Key inclusion criteria
Men: over 18, healthy
Women: over 18, healthy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Non randomised
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Open, non-randomized interventional study in healthy volunteers to obtain blood and urine samples for steroid analysis
Phase
Not Applicable
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
8
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258306 0
Government body
Name [1] 258306 0
United States Anti Doping Agency (USADA)
Country [1] 258306 0
United States of America
Primary sponsor type
Hospital
Name
Sydney South West Area Health Authority (SSWAHS)
Address
Concord Repatriation General Hospital
Conocrd NSW 2139
Country
Australia
Secondary sponsor category [1] 257471 0
None
Name [1] 257471 0
Address [1] 257471 0
Country [1] 257471 0
Other collaborator category [1] 251769 0
Other Collaborative groups
Name [1] 251769 0
National Measurement Institute
Address [1] 251769 0
Dr Catrin Goebel
Australian Sports Drug Testing Laboratory
National Measurement Institute
1 Suakin Street
Pymble
NSW 2073
Country [1] 251769 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 260295 0
Concord Hospital, Human Research Ethics Committee (HREC)
Ethics committee address [1] 260295 0
Ethics committee country [1] 260295 0
Australia
Date submitted for ethics approval [1] 260295 0
20/10/2010
Approval date [1] 260295 0
Ethics approval number [1] 260295 0
HREC/10/CRGH/168

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

Contacts
Principal investigator
Name 31819 0
Address 31819 0
Country 31819 0
Phone 31819 0
Fax 31819 0
Email 31819 0
Contact person for public queries
Name 15066 0
D J Handelsman
Address 15066 0
Anzac Research Institute
Hospital Road
Concord NSW 2139
Country 15066 0
Australia
Phone 15066 0
00612 9767 7222
Fax 15066 0
00612 9767 7221
Email 15066 0
djh@anzac.edu.au
Contact person for scientific queries
Name 5994 0
D J Handelsman
Address 5994 0
Anzac Research Institute
Hospital Road
Concord NSW 2139
Country 5994 0
Australia
Phone 5994 0
00612 9767 7222
Fax 5994 0
00612 9767 7221
Email 5994 0
djh@anzac.edu.au

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
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Documents added automatically
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