Influence of Administration Route of Testosterone on Male Fertility - Full Text View

Purpose

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.

Condition	Intervention	Phase
Hypogonadism	Drug: MPP10, testosterone Drug: Testosterone	Phase I

ChemIDplus related topics:

Testosterone Methyltestosterone Oxymesterone Testosterone enanthate Testosterone Propionate Testosterone undecanoate

U.S. FDA Resources

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

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

Further study details as provided by M et P Pharma:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	20
Study Start Date:	August 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group 1: Experimental 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).
Group 2: Active Comparator Group 2 will be treated with AndroGel® 50 mg, once daily in the morning after washing/showering.	Drug: Testosterone AndroGel® 50 mg, once daily in the morning after washing/showering.

Eligibility

Ages Eligible for Study:	50 Years to 80 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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);

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00705796

Contacts


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

Locations


Netherlands
	AMPHA	Not yet recruiting
	Nijmegen, Netherlands, 6525 EC
	Contact: Margarita Budumian, MD 31-2-4388-8960
	Principal Investigator: Margarita Budumian, MD

Sponsors and Collaborators

M et P Pharma

Investigators


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

More Information

Responsible Party:	M et P Pharma ( Sponsor, CEO U. Mattern )
Study ID Numbers:	Nasobol 02/2008
First Received:	June 25, 2008
Last Updated:	June 25, 2008
ClinicalTrials.gov Identifier:	NCT00705796
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by M et P Pharma:

Hypogonadism

Spermatogenesis

Quality of Life

Study placed in the following topic categories:

Testosterone

Hypogonadism

Gonadal Disorders

Quality of Life

Endocrine System Diseases

Methyltestosterone

Endocrinopathy

Testosterone 17 beta-cypionate

Additional relevant MeSH terms:

Anabolic Agents

Antineoplastic Agents, Hormonal

Antineoplastic Agents

Therapeutic Uses

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Hormones

Pharmacologic Actions

Androgens

ClinicalTrials.gov processed this record on September 23, 2008

Sponsored by:	M et P Pharma
Information provided by:	M et P Pharma
ClinicalTrials.gov Identifier:	NCT00705796