Detection of Dehydroepiandrosterone (DHEA) Augmentation Doping: Pilot Study

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2011
INTERVENTION: 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. CONDITION: The effect of oral DHEA with and without other steroid precursors, as a sports doping agent on healthy adult males and females. PRIMARY OUTCOME: 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. 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. SECONDARY OUTCOME: 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. INCLUSION CRITERIA: Men: over 18, healthy Women: over 18, healthy
Epistemonikos ID: 70275befe2b4e92a510bab5bf56e7e81cb8c0c7f
First added on: Aug 22, 2024