Influence of Administration Route of Testosterone on Male Fertility

This study has been withdrawn prior to enrollment.
(financial constraints)
Sponsor:
Information provided by:
M et P Pharma
ClinicalTrials.gov Identifier:
NCT00705796
First received: June 25, 2008
Last updated: May 3, 2012
Last verified: May 2012
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Influence on Human Male Fertility of Testosterone After Intranasal (MPP10) or Transdermal (AndroGel™) Application

Resource links provided by NLM:


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 ]

Enrollment: 0
Arms Assigned Interventions
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 Name: 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 Name: AndroGel

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Netherlands
AMPHA
Nijmegen, Netherlands, 6525 EC
Sponsors and Collaborators
M et P Pharma
Investigators
Principal Investigator: Margarita Budumian, MD AMPHA, Toernooiveld 220, 6525 EC Nijmegen, The Netherlands
  More Information

No publications provided

Responsible Party: Sponsor, CEO U. Mattern, M et P Pharma
ClinicalTrials.gov Identifier: NCT00705796     History of Changes
Other Study ID Numbers: Nasobol 02/2008
Study First Received: June 25, 2008
Last Updated: May 3, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by M et P Pharma:
Hypogonadism
Spermatogenesis
Quality of Life

Additional relevant MeSH terms:
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on August 01, 2014