To study whether there is an individual setpoint for the hypothalamus-pituitary-gonad axis in men
ID
Source
Brief title
Condition
- Endocrine disorders of gonadal function
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
levels of total testosterone and 17-OH-progesterone before and during
ketoconazole use and after application of human chorionic gonadotropin
Secondary outcome
not applicable
Background summary
In men testosterone (T) production takes place in the testes under the
stimulating influence of pituitary derived luiteinzing hormone (LH). LH is
stimulated by the pulsatile relaese of gonadotropin releasing hormone (GnRH) by
the hypothalamus.
LH and GnRH release are inhibited by circulating testosterone. The
intraindividual variation of the testosterone concentration appears to be much
smaller than the interindividual variation. From this one may conclude that
every man has a individual setpoint for the regulation of the
hypothalamus-pituitary-gonad axis.
Study objective
To study whether there is an individual setpoint for the
hypothalamus-pituitary-gonad axis in men
Study design
open lable intervention
Intervention
ketoconazole 4 times 100 mg daily for 9 days.
human chorionic gonadotropin 5000 IE once.
Study burden and risks
18 x venepuncture, on days 1, 8 and 15 blood is drawn via a intravenous
catheter (total 250 ml)
possible side effects of ketoconazole: gastrointestinal complaints, headache,
vertigo, exanthema, pruritis, transient increase of liver enzymes. The chances
of having side effects is small when ketoconazole is adminstered for less that
14 days. For safety reasons liver enzymes will be tested after 5 days of
ketoconazole use and when liver enzyms increase more than two times the upper
refence limit the subject will be withdrawn from the study.
postbus 7057
1007 mb
Nederland
postbus 7057
1007 mb
Nederland
Listed location countries
Age
Inclusion criteria
male, age 18-40 years, healthy
Exclusion criteria
intolerability of ketoconazole, use of testosterone, aldactone, finasteride, estradiol. Elevated liver enzymes, hypogonadism (T<10 nmol/l, LH > 8 IU/l), elevated estradiol level (>250 pmol/l)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL15788.029.07 |