NCT00705796

Influence of Administration Route of Testosterone on Male Fertility

Influence on Human Male Fertility of Testosterone After Intranasal (MPP10) or Transdermal (AndroGel™) Application

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Acerus Pharmaceuticals Corporation · Industry
• Sex: Male
• Age: 50 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Hypogonadism

Interventions

Type	Name	Description
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).
DRUG	Testosterone	AndroGel® 50 mg, once daily in the morning after washing/showering.

Timeline

• First posted: 2008-06-26
• Last updated: 2018-03-13

Locations

1 site across 1 country: Netherlands