Working… Menu

Influence of Administration Route of Testosterone on Male Fertility

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00705796
Recruitment Status : Withdrawn (financial constraints)
First Posted : June 26, 2008
Last Update Posted : March 13, 2018
Information provided by:
Acerus Pharmaceuticals Corporation

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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

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 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

Primary Outcome Measures :
  1. 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 Measures :
  1. The effects of treatment on the health related quality of life (QoL); [ Time Frame: 4 months ]
  2. 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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
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);

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00705796

Layout table for location information
Nijmegen, Netherlands, 6525 EC
Sponsors and Collaborators
Acerus Pharmaceuticals Corporation
Layout table for investigator information
Principal Investigator: Margarita Budumian, MD AMPHA, Toernooiveld 220, 6525 EC Nijmegen, The Netherlands

Layout table for additonal information
Responsible Party: Sponsor, CEO U. Mattern, M et P Pharma Identifier: NCT00705796     History of Changes
Other Study ID Numbers: Nasobol 02/2008
First Posted: June 26, 2008    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018
Keywords provided by Acerus Pharmaceuticals Corporation:
Quality of Life
Additional relevant MeSH terms:
Layout table for MeSH terms
Gonadal Disorders
Endocrine System Diseases
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents