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| Sponsor: | M et P Pharma |
|---|---|
| Information provided by: | M et P Pharma |
| ClinicalTrials.gov Identifier: | NCT00647868 |
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 II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics Study |
| 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 |
| Estimated Enrollment: | 16 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | May 2009 |
| Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Groups 1 and 2: Experimental
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
|
|
Groups 3a and b: Experimental
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
|
|
Group 4: No Intervention
24-h blood sampling in healthy eugonadal controls
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Other: No treatment
24-h blood sampling in healthy, eugonadal men
|
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 |
Inclusion Criteria for hypogonadal subjects:
Exclusion Criteria for hypogonadal subjects:
Inclusion criteria for eugonadal subjects:
Exclusion criteria for eugonadal subjects:
Contacts and Locations| Contact: Claudia Mattern | +41 41 618 30 30 | cu.mattern@bluewin.ch |
| Contact: Udo Mattern | +41 41 618 30 30 | cu.mattern@bluewin.ch |
| United States, California | |
| Harbor - UCLA Medical Center | Recruiting |
| Torrance, California, United States, 90509 | |
| Contact: Christina Wang, MD 310-222-2503 wang@labiomed.org | |
| Principal Investigator: Christina Wang, MD | |
| Principal Investigator: | Christina Wang, MD | General Clinical Research Center - Harbor UCLA Medical center |
More Information
| Responsible Party: | General Clinical Research Center, Harbor-UCLA Medical Center ( Prof. Dr. C. Wang, MD ) |
| Study ID Numbers: | Nasobol 01/2008 |
| Study First Received: | March 27, 2008 |
| Last Updated: | January 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00647868 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
pharmacokinetics testosterone hypogonadism |
|
Antineoplastic Agents, Hormonal Gonadal Disorders Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Endocrine System Diseases Methyltestosterone Hormones |
Pharmacologic Actions Testosterone 17 beta-cypionate Anabolic Agents Testosterone Hypogonadism Therapeutic Uses Androgens |