Influence of Administration Route of Testosterone on Male Fertility

March 9, 2018 updated by: Acerus Pharmaceuticals Corporation

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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);

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The effects of treatment on the health related quality of life (QoL);
Time Frame: 4 months
4 months
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
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acerus Pharmaceuticals Corporation

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

June 25, 2008

First Submitted That Met QC Criteria

June 25, 2008

First Posted (ESTIMATE)

June 26, 2008

Study Record Updates

Last Update Posted (ACTUAL)

March 13, 2018

Last Update Submitted That Met QC Criteria

March 9, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nasobol 02/2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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