Influence of Administration Route of Testosterone on Male Fertility

Sponsor

Acerus Pharmaceuticals Corporation (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT00705796

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypogonadism	Drug: MPP10, testosterone Drug: Testosterone	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Arms and Interventions

Arm	Intervention/Treatment
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).	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). Other Names: Nasobol
Active Comparator: Group 2 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. Other Names: AndroGel

Arm

Intervention/Treatment

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).

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).

Other Names:

Nasobol

Active Comparator: Group 2

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.

Other Names:

AndroGel

Outcome Measures

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. [4 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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);