Hypogonadism Clinical Trial
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
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.
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 I, 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.
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