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Sponsored by: |
M et P Pharma |
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Information provided by: | M et P Pharma |
ClinicalTrials.gov Identifier: | NCT00705796 |
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 |
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Hypogonadism |
Drug: MPP10, testosterone Drug: Testosterone |
Phase I |
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 |
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 |
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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).
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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).
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Group 2: Active Comparator
Group 2 will be treated with AndroGel® 50 mg, once daily in the morning after washing/showering.
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Drug: Testosterone
AndroGel® 50 mg, once daily in the morning after washing/showering.
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Ages Eligible for Study: | 50 Years to 80 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Margarita Budumian, MD | 31-2-4388-8960 |
Netherlands | |
AMPHA | |
Nijmegen, Netherlands, 6525 EC |
Principal Investigator: | Margarita Budumian, MD | AMPHA, Toernooiveld 220, 6525 EC Nijmegen, The Netherlands |
Responsible Party: | M et P Pharma ( Sponsor, CEO U. Mattern ) |
Study ID Numbers: | Nasobol 02/2008 |
Study First Received: | June 25, 2008 |
Last Updated: | June 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00705796 History of Changes |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Hypogonadism Spermatogenesis Quality of Life |
Infertility Antineoplastic Agents, Hormonal Gonadal Disorders Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Endocrine System Diseases Quality of Life Methyltestosterone |
Hormones Testosterone 17 beta-cypionate Anabolic Agents Testosterone Hypogonadism Endocrinopathy Androgens |
Antineoplastic Agents, Hormonal Gonadal Disorders Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Endocrine System Diseases Methyltestosterone Hormones |
Pharmacologic Actions Testosterone 17 beta-cypionate Anabolic Agents Testosterone Hypogonadism Therapeutic Uses Androgens |