Clinical trial NCT00705796: Influence of Administration Route of Testosterone on Male Fertility
Official title: Influence on Human Male Fertility of Testosterone After Intranasal (MPP10) or Transdermal (AndroGel™) Application
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Hypogonadism
Keywords: Hypogonadism
Spermatogenesis
Quality of Life
Lead sponsor: Acerus Pharmaceuticals Corporation
Sponsor class: INDUSTRY
First posted: 2008-06-26
Enrollment: 0
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 50 years but not older than 80 years of age;
* Serum testosterone level \<13.8 nmol/l;
* Sperm concentration \> 40 Million/ml;
* Willing to give written informed consent.

Exclusion Criteria:

* Testicular diseases or having had any surgical procedures applied to the testes;
* History or currently existing serious disease of any type, in particular liver, kidney or heart disease, any form of diabetes mellitus, cancer or psychiatric illness;
* Current androgen, anabolic steroid or sex hormone treatment or any treatment with such compounds in the previous 6 months;
* Blood donation within the 12-week period before the initial study dose.
* History of, or current nasal disorders (e.g. seasonal or perennial allergic rhinitis, atrophic rhinitis, polyposis, abuse of nasal decongestants, clinically relevant nasal septum deviation, recurrent epistaxis) or sleep apnea;
* Elevated serum PSA levels (\> 4 ng/ml for subjects \>= 50 years of age);

Primary outcomes:
measure: The main study parameter is the change in sperm concentration during the 4-month study period for each of the two treatment groups.
timeFrame: 4 months
Secondary outcomes:
measure: The effects of treatment on the health related quality of life (QoL);
timeFrame: 4 months
measure: The influence of transdermal and intranasal testosterone treatment on morphology and motility on sperm cells and on the volume of the ejaculate;
timeFrame: 4 months
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: AMPHA
Study officials:
affiliation: AMPHA, Toernooiveld 220, 6525 EC Nijmegen, The Netherlands
name: Margarita Budumian, MD
role: PRINCIPAL_INVESTIGATOR
References: