NASOBOL in Hypogonadal Men in Comparison to Testosterone Levels in Normal Healthy Male Volunteers

This study has been completed.
Sponsor:
Information provided by:
M et P Pharma
ClinicalTrials.gov Identifier:
NCT00647868
First received: March 27, 2008
Last updated: May 2, 2012
Last verified: May 2012
  Purpose

In this study the serum concentration of testosterone and its main metabolite DHT will be measured in hypogonadal men using intranasal testosterone (Nasobol). Different treatment regimens (once and twice daily) and administration times will be tested. The serum levels obtained will be compared with those of healthy men.

It is expected that intranasal administration of Nasobol will restore testosterone and DHT levels to nearly normal.


Condition Intervention Phase
Hypogonadism
Drug: testosterone
Other: No treatment
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multiple Dose, Pharmacokinetic Study Comparing Different Regimens of Testosterone Given as Intranasal NASOBOL® in Hypogonadal Men in Comparison to Testosterone Levels in Normal Healthy Male Volunteers

Resource links provided by NLM:


Further study details as provided by M et P Pharma:

Primary Outcome Measures:
  • Testosterone serum concentration [ Time Frame: 14 and 28 days after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference of serum T levels in treated hypogonadal men vs. eugonadal men [ Time Frame: After 14 and 28 days of treatment ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: May 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Groups 1 and 2
Twice daily (7:00 am and 12:00 am or 7:00 am and 10:00 pm) dosing with intranasal testosterone for 14 days
Drug: testosterone
Intranasal testosterone, 7.6 mg (3.8 mg in each nostril) per application
Other Name: Nasobol
Experimental: Groups 3a and b
Single daily administration of testosterone (at 7:00 am or 10:00 pm) for 14 days
Drug: testosterone
Intranasal testosterone, 7.6 mg (3.8 mg in each nostril) per application
Other Name: Nasobol
No Intervention: Group 4
24-h blood sampling in healthy eugonadal controls
Other: No treatment
24-h blood sampling in healthy, eugonadal men

Detailed Description:

This pharmacokinetic trial is performed with the aim to determine the pharmacokinetic behavior of testosterone after repeated nasal administration of NASOBOL® in patients with hypogonadism and to compare the levels of the major analytes to levels seen in normal healthy men. For this purpose, four different treatment schedules of administration of NASOBOL® will be tested and compared to 24-h levels in normal healthy men.

This is a Phase II, pharmacokinetic trial with different administration schemes of NASOBOL® in patients with moderate hypogonadism (Groups 1, 2 and 3). For reference purposes frequent blood samples will be taken in a group of healthy men (Group 4). Subjects will be screened for eligibility not more than 4 weeks before the 1st dose of NASOBOL®. Total study duration for hypogonadal patients is maximally 38 days (including a 3 days placebo run-in phase). Healthy men will be screened for eligibility and will be in the clinic for only 1 day (with overnight stay) during the study.

For hypogonadal patients 7 visits to the clinic are planned, amongst which 2 visits for 24-h PK sampling each with an overnight stay. Seven days after the last dose of NASOBOL® hypogonadal patients will be asked to come to the clinic for a final follow-up visit.

Telephone follow-ups will be done on Days 7, 13, 21 and 27 to check whether subjects have taken their medication.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for hypogonadal subjects:

  • men with primary or secondary hypogonadism and testosterone serum levels below 300 ng/dl [= 10.4 nmol/l], on two occasions within a period of one month before inclusion;
  • age: 20-60 years;
  • normal thyroid function, physiologic prolactin concentration;
  • normal otorhinolaryngologic examination (ENT examination);
  • normal 24-h activity-rest pattern;
  • written Informed Consent.

Exclusion Criteria for hypogonadal subjects:

  • significant intercurrent disease of any type, in particular liver, kidney or heart disease, any form of diabetes mellitus or psychiatric illness (patients with treated hyperlipidemia, arterial hypertension or treated hyper- or hypothyroidism will not be excluded provided they have been stable on their medication for at least two months);
  • 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;
  • sleeping disorders;
  • abnormal prostate examination indicative for prostate cancer or elevated serum PSA levels (PSA < 2.5 ng/ml for subjects < 40 years of age and < 4 ng/ml for subjects >= 40 years of age);
  • history of cancer, especially breast, prostate or testicular tumor; excluding skin cancer;
  • history of severe or multiple allergies, severe adverse drug reaction or leucopenia. A known hypersensitivity to lignocaine/lidocaine or all surgical dressings which may be used in the study procedures;
  • history of abnormal bleeding tendencies or thrombophlebitis unrelated to venepuncture or intravenous cannulation, or a history of Hepatitis B, a positive test for Hepatitis B surface antigen, a history of Hepatitis C, a positive test for Hepatitis C antibody, a history of HIV infection or demonstration of HIV antibodies;
  • the patient is a heavy smoker currently smoking > 20 cigarettes per day or smoking history >10 pack years (1 pack year is defined as 20 cigarettes per day for 1 year);
  • regular drinkers of more than four (4) units of alcohol daily (1 unit = 300 ml of beer, 1 glass of wine, 1 measure of spirit) or those who may have difficulty in abstaining from alcohol during the 48 hours prior to the initial-dose administration and for the duration of the study;
  • history or current evidence of abuse of alcohol or any drug substance, licit or illicit; or positive urine drug and alcohol screen for drugs of abuse and alcohol;
  • treatment with other androgens (e.g. DHEA), anabolic steroids or other sex hormones within one month prior to Day 1 of the study;
  • testosterone treatment in the previous 2 weeks (oral, buccal, topical, nasal) or 4 weeks (intramuscular);
  • current or recent (previous 4 weeks) use of over the counter male enhancement products;
  • use of nasal decongestants and nasal corticosteroids;
  • shift work;
  • transmeridian flights within 1 month before Day 1 of the study;
  • poor compliers or those unlikely to attend;
  • intake of any drug as part of a research study within 30 days of initial-dose administration in this study and throughout the study;
  • blood donation within the 12-week period before the initial study dose.

Inclusion criteria for eugonadal subjects:

  • men with testosterone serum levels above 300 ng/dl [= 10.4 nmol/l] on two occasions within a period of one month before inclusion;
  • age: 20-60 years;
  • normal thyroid function, physiologic prolactin concentration;
  • normal 24-h activity-rest pattern;
  • written Informed Consent.

Exclusion criteria for eugonadal subjects:

  • significant intercurrent disease of any type, in particular liver, kidney or heart disease, any form of diabetes mellitus or psychiatric illness (patients with treated hyperlipidemia, arterial hypertension or treated hyper- or hypothyroidism will not be excluded provided they have been stable on their medication for at least two months);
  • history of hypogonadism;
  • sleeping disorders;
  • treatment with other androgens (e.g. DHEA), anabolic steroids or other sex hormones within one month prior to Day 1 of the study;
  • testosterone treatment in the previous 2 weeks (oral, buccal, topical, nasal) or 4 weeks (intramuscular);
  • current or recent (previous 4 weeks) use of over the counter male enhancement products;
  • shift work;
  • transmeridian flights within 1 month before Day 1 of the study;
  • the patient is a heavy smoker currently smoking > 20 cigarettes per day or smoking history >10 pack years (1 pack year is defined as 20 cigarettes per day for 1 year);
  • regular drinkers of more than four (4) units of alcohol daily (1 unit = 300 ml of beer, 1 glass of wine, 1 measure of spirit) or those who may have difficulty in abstaining from alcohol during the 48 hours prior to the 24-h blood sampling day;
  • blood donation within the 12-week period before the 24-h blood sampling day.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00647868

Locations
United States, California
Harbor - UCLA Medical Center
Torrance, California, United States, 90509
Sponsors and Collaborators
M et P Pharma
Investigators
Principal Investigator: Christina Wang, MD General Clinical Research Center - Harbor UCLA Medical center
  More Information

No publications provided

Responsible Party: Prof. Dr. C. Wang, MD, General Clinical Research Center, Harbor-UCLA Medical Center
ClinicalTrials.gov Identifier: NCT00647868     History of Changes
Other Study ID Numbers: Nasobol 01/2008
Study First Received: March 27, 2008
Last Updated: May 2, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by M et P Pharma:
pharmacokinetics
testosterone
hypogonadism

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 April 17, 2014