Influence of Administration Route of Testosterone on Male Fertility

Hypogonadism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00705796
• Other study ID #: Nasobol 02/2008
• Status: Withdrawn
• Phase: Phase 1
• First received: June 25, 2008
• Last updated: March 9, 2018

Study information

• Verified date: March 2018
• Source: Acerus Pharmaceuticals Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years to 80 Years

Eligibility

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);

Related Conditions & MeSH terms

• Hypogonadism

Intervention

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).
• Testosterone
AndroGel® 50 mg, once daily in the morning after washing/showering.

Locations

Country	Name	City	State
Netherlands	AMPHA	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Acerus Pharmaceuticals Corporation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The main study parameter is the change in sperm concentration during the 4-month study period for each of the two treatment groups.		4 months
Secondary	The effects of treatment on the health related quality of life (QoL);		4 months
Secondary	The influence of transdermal and intranasal testosterone treatment on morphology and motility on sperm cells and on the volume of the ejaculate;		4 months