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Plasma testosterone levels in hypogonadal individuals treated with Androgel, impact of showering shortly after application.


- candidate number4722
- NTR NumberNTR1582
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-dec-2008
- Secondary IDs2008/227 metc
- Public TitlePlasma testosterone levels in hypogonadal individuals treated with Androgel, impact of showering shortly after application.
- Scientific TitlePlasma testosterone levels in hypogonadal individuals treated with Androgel, impact of showering shortly after application.
- ACRONYMN/A
- hypothesisShowering shortly after application of Androgel does not negatively affect testosterone plasma levels.
- Healt Condition(s) or Problem(s) studiedtestosteron transfer
- Inclusion criteriaFemale to male transsexual after orchiectomy.
- Exclusion criteria1. skin conditions;
2. known intolerance for Androgel.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupCrossover
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jan-2009
- planned closingdate1-jun-2009
- Target number of participants10
- InterventionsRegimen A: androgel 50 mg daily after showering;
Regimen B: androgel 50 mg 15 minutes before showering;
Regimen C: androgel 50 mg 30 minutes before showering.
- Primary outcomeMaximal plasma testosterone concentration, AUC and time average concentration on day 7 of each treatment regime.
- Secondary outcomeN/A
- TimepointsPlasma sampling at 08:00, 09:00, 12:00, 15:00 and 18:00 of day 7 of each regime.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. dr. J.T. Dissel, van
- CONTACT for SCIENTIFIC QUERIESProf. dr. J.T. Dissel, van
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD12-dec-2008 - 12-jan-2009


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