Influence of Administration Route of Testosterone on Male Fertility

NCT00705796 | Withdrawn Phase 1

• 1 other identifier: Nasobol 02/2008
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypogonadism

Keywords

Hypogonadism; Spermatogenesis; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The effects of treatment on the health related quality of life (QoL);

  4 months

• The influence of transdermal and intranasal testosterone treatment on morphology and motility on sperm cells and on the volume of the ejaculate;

  4 months

Study Arms (2)

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

Group 2

ACTIVE COMPARATOR

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

Drug: Testosterone

Interventions

MPP10, testosterone DRUG

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).

Also known as: Nasobol

Group 1

Testosterone DRUG

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

Also known as: AndroGel

Group 2

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Acerus Pharmaceuticals Corporation: lead

Study Sites (1)

AMPHA

Nijmegen, 6525 EC, Netherlands

Location

MeSH Terms

Conditions

Hypogonadism

Interventions

Testosterone

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Margarita Budumian, MD

  AMPHA, Toernooiveld 220, 6525 EC Nijmegen, The Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 25, 2008
• First Posted: June 26, 2008
• Last Updated: March 13, 2018

Record last verified: 2018-03

Locations

NL (1)