None listed
Conditions
Brief summary
There are currently 2 forms of injectable hCG available in Australia. One is derived from urine (Pregnyl) and the other is genetically engineered (Ovidrel). hCG is used to treat men and women with certain types of infertility. However only Pregnyl is available for use in males. If Pregnyl is withdrawn from the market then there will no alternative form of treatment for infertile men. We aim to compare the action of both forms of hCG in healthy males to determine if Ovidrel has the same pharmacological effects as Pregnyl, when given to men.
Interventions
Part 1: a randomised single dose two phase cross over study. 10 healthy men will receive intramuscular (IM) nandrolone decanoate (ND) 200mg on day 0. Then will be randomised to recieve 1500iu subcutaneous (s/c) injection of either rhCG (Ovidrel) or uhCG (Pregnyl) on day 3/week one followed by s/c rhCG or uhCG on day 10/ week 2 (crossover design).
IM Nandrolone decanoate injections will be repeated on days 4 (100mg), 7 (200mg) and 11 (100mg).
Part 2: a parallel (two) group, multi-dose study
16
Part 1: a randomised single dose two phase cross over study. 10 healthy men will receive intramuscular (IM) nandrolone decanoate (ND) 200mg on day 0. Then will be randomised to recieve 1500iu subcutaneous (s/c) injection of either rhCG (Ovidrel) or uhCG (Pregnyl) on day 3/week one followed by s/c rhCG or uhCG on day 10/ week 2 (crossover design). IM Nandrolone decanoate injections will be repeated on days 4 (100mg), 7 (200mg) and 11 (100mg). Part 2: a parallel (two) group, multi-dose study 16 healthy men will be recruited into the study. After consent is provided, each participant will undergo suppression of endogenous T levels prior to and during gonadotrophin treatment by administration of a 200mg intramuscular injections of ND. IM Nandrolone decanoate injections will be repeated on days 5 (100mg), 7 (200mg) and 12 (100mg). After the first ND injection, men will be randomised to receive either Pregnyl 1500iu or Ovidrel 1500iu by subcutaneous injection on days 3, 5, 7 and 10. All participants will have a single 5ml blood sample taken for Deoxyribonucleic acid (DNA) analysis in order to investigate genetic predictors of variable responses to hCG.
Sponsors
Concord Repatriation General Hospital (CRGH)
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Healthy men over 18 years of age
Exclusion criteria
History of: 1. Chronic disease or condition requiring regular medical treatment, 2. Male infertility or pituitary-testicular dysfunction 3. Androgen (anabolic steriod) use or abuse
Outcome results
None listed