Influence of Administration Route of Testosterone on Male Fertility
Exogenously administered testosterone will override the normal negative feedback of endogenous testosterone on the hypothalamus and pituitary. Constantly, relatively high and constant testosterone levels will cause a drop in FSH and LH production by the pituitary. Since FSH and LH are signalling hormones to the testes, endogenous testosterone production and spermatogenesis will be down-regulated. It is expected that intranasal dosing in the morning will mimic the normal physiological pattern of testosterone production thereby avoiding negative side-effects on spermatogenesis. Trans-dermal gels give testosterone levels more or less constant over the day and will very likely have inhibitory effects on spermatogenesis.
The main objective of this study is to show that twice daily intranasal dosing does not have, or has a smaller inhibitory effect on spermatogenesis in comparison to transdermal testosterone gels.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Influence on Human Male Fertility of Testosterone After Intranasal (MPP10) or Transdermal (AndroGel™) Application|
- The main study parameter is the change in sperm concentration during the 4-month study period for each of the two treatment groups. [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
- The effects of treatment on the health related quality of life (QoL); [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- The influence of transdermal and intranasal testosterone treatment on morphology and motility on sperm cells and on the volume of the ejaculate; [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
Experimental: Group 1
Group 1 will be treated with MPP10, 7.6 mg, twice daily to be taken immediately after waking up and washing/showering (approx. 7:00-8:00 AM) and at lunch time (approx. 12:00 AM).
Drug: MPP10, testosterone
Testosterone intranasal, 7.6 mg, twice daily to be taken immediately after waking up and washing/showering (approx. 7:00-8:00 AM) and at lunch time (approx. 12:00 AM).
Other Name: Nasobol
Active Comparator: Group 2
Group 2 will be treated with AndroGel® 50 mg, once daily in the morning after washing/showering.
AndroGel® 50 mg, once daily in the morning after washing/showering.
Other Name: AndroGel
Please refer to this study by its ClinicalTrials.gov identifier: NCT00705796
|Nijmegen, Netherlands, 6525 EC|
|Principal Investigator:||Margarita Budumian, MD||AMPHA, Toernooiveld 220, 6525 EC Nijmegen, The Netherlands|