Detection of Dehydroepiandrosterone (DHEA) Augmentation Doping: Pilot Study

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.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000042943

Enrollment

Registered

2011-01-12

Start date

2011-02-03

Completion date

2011-03-17

Last updated

2026-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Non-randomised trial

Intervention model

Other

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Men: over 18, healthy Women: over 18, healthy

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.

Outcome results