to investigate whether showering shortly after Androgel application adversly affects plasma testosterone levels.
ID
Source
Brief title
Condition
- Endocrine disorders of gonadal function
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
maximal testosterone level
area under the curve
time average concentration
Secondary outcome
na
Background summary
Androgel (transdermal testosterone) is the most used mode of androgen
supplementation in the Netherlands. A potential drwaback associated with the
use of this gel is the potential of unvoluntary testosterone transfer to women
and children. Taking a shower after application of the gel prevents significant
transfer, however it may potentially diminish testosteron uptake by the skin.
Study objective
to investigate whether showering shortly after Androgel application adversly
affects plasma testosterone levels.
Study design
prospective, randomized, cross-over
Intervention
during three weeks Androgel 50 mg in three regimes of one week
-application after showering
-application 15 minutes before showering
-application 30 minutes before showering
Study burden and risks
the use of Androgel 50 mg (very low risk, low burden)
on three days, at the end of every study week at 5 time points blood is drawn
(7 ml; 15 blood tests in total) at 08:00 h, 09:00 h, 12:00 h, 16:00h, 18:00h
(low risk, moderate burden)
postbus 7057
1007 mb
Nederland
postbus 7057
1007 mb
Nederland
Listed location countries
Age
Inclusion criteria
female-to male transsexual after gonadectomy
age 18-60 years
Exclusion criteria
known intolerance for a Androgel
chronic skin condition
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 | NL24711.029.08 |