Official Title: “Influence on Human Male Fertility of Testosterone After Intranasal (MPP10) or Transdermal (AndroGel™) Application”

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 Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: February 2009

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• 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).
• Active Comparator: Group 2
  • Group 2 will be treated with AndroGel® 50 mg, once daily in the morning after washing/showering.

Primary Measures

• 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
    Safety Issue?: Yes

Secondary Measures

• The effects of treatment on the health related quality of life (QoL);
  • Time Frame: 4 months
    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
    Safety Issue?: Yes

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);

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: M et P Pharma

Overall Clinical Trial Officials and Contacts

Margarita Budumian, MD Principal Investigator AMPHA, Toernooiveld 220, 6525 EC Nijmegen, The Netherlands  

Overall Contact: Margarita Budumian, MD 31-2-4388-8960 

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00705796

Study ID Number: Nasobol 02/2008

ClinicalTrials.gov Identifier: NCT00705796

Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)