Comparative pharmacokinetics and pharmcodynamics of recombinant and urinary human chorionic gonadotrophin (rhCG vs uhCG)
Phase 4
Completed
- Conditions
- Comparative pharmacological effects of two different preparations of human chorionic gonadotrophin (hCG) in menMetabolic and Endocrine - Normal metabolism and endocrine development and function
- Registration Number
- ACTRN12609000462280
- Lead Sponsor
- Concord Repatriation General Hospital (CRGH)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 32
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the pharmacokinetic (serum hCG) and pharmacodynamic (serum testosterone) effect of each hCG product in a single dose, cross over randomised sequence, clinical trial in healthy men who have temporary supression of endogenous luteinising hormone (LH) and testosterone (T) in order to observe the pharmacology of the two hCG products on serum testosterone concentrations in the abscence of endogenous testosterone.[Blood samples will be collected at baseline and then on the morning of days 3, 4, 5, 6, 7, 10, 11, 12, 13, 14 and 17.]
- Secondary Outcome Measures
Name Time Method To evaluate the effect of multiple (4) doses of each hCG product on the pharmacokinetics (serum hCG) and pharmacokinetics (serum T) levels in a randomised, parallel group clinical trial of healthy men undergoing supression of endogenous LH and T using nandrolone.[Blood samples will be taken at baseline and then on each morning of days 3, 4, 5, 6, 7, 10, 11, 12, 13, 14 and 17.]