search
Back to results

Influence of Administration Route of Testosterone on Male Fertility

Primary Purpose

Hypogonadism

Status
Withdrawn
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
MPP10, testosterone
Testosterone
Sponsored by
Acerus Pharmaceuticals Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypogonadism focused on measuring Hypogonadism, Spermatogenesis, Quality of Life

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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);

Sites / Locations

  • AMPHA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

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).

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

Outcomes

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.

Secondary Outcome Measures

The effects of treatment on the health related quality of life (QoL);
The influence of transdermal and intranasal testosterone treatment on morphology and motility on sperm cells and on the volume of the ejaculate;

Full Information

First Posted
June 25, 2008
Last Updated
March 9, 2018
Sponsor
Acerus Pharmaceuticals Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT00705796
Brief Title
Influence of Administration Route of Testosterone on Male Fertility
Official Title
Influence on Human Male Fertility of Testosterone After Intranasal (MPP10) or Transdermal (AndroGel™) Application
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Withdrawn
Why Stopped
financial constraints
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Acerus Pharmaceuticals Corporation

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism
Keywords
Hypogonadism, Spermatogenesis, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
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).
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Group 2 will be treated with AndroGel® 50 mg, once daily in the morning after washing/showering.
Intervention Type
Drug
Intervention Name(s)
MPP10, testosterone
Other Intervention Name(s)
Nasobol
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Testosterone
Other Intervention Name(s)
AndroGel
Intervention Description
AndroGel® 50 mg, once daily in the morning after washing/showering.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
The effects of treatment on the health related quality of life (QoL);
Time Frame
4 months
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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);
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margarita Budumian, MD
Organizational Affiliation
AMPHA, Toernooiveld 220, 6525 EC Nijmegen, The Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
AMPHA
City
Nijmegen
ZIP/Postal Code
6525 EC
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

Influence of Administration Route of Testosterone on Male Fertility

We'll reach out to this number within 24 hrs