CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 11 enrolled
Drug / intervention
First Intervention (7 days) +4 moredrug
Likely dose
First Intervention (7 days) 300mcg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00842751
NCT00842751Phase 2Completed
CompareCT.gov

Pharmacokinetics of a Novel Oral Testosterone Undecanoate Formulation With Concomitant Inhibition of 5alpha-Reductase by Finasteride

University of Washington·interventional·Posted Feb 12, 2009·Updated Jan 13, 2014

In Brief

A Phase 2 clinical trial evaluating First Intervention (7 days), First Washout (7 days), and 3 other interventions for Healthy Males and Male Contraceptive. Completed, enrolled 11 participants across 1 site.

Detailed Summary

The purpose of this study is to test how the body absorbs and processes new forms of oral testosterone. Information gained during the study may help develop better forms of testosterone therapy in the future.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Males, Male Contraceptive
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 12, 2009
Enrollment StartJul 1, 2009
Primary CompletionNov 1, 2009
Study CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 17.4 years ago

Interventions

First Intervention (7 days)drug

Acyline 300mcg/kg subcutaneous (days 1, 15 \& 29) + testosterone undecanoate 200 mg, twice daily orally + finasteride placebo

First Washout (7 days)other

Washout of 7 days between each of the 3 treatment arms

Second Intervention (7 days)drug

Acyline 300mcg/kg subcutaneous + testosterone undecanoate 200 mg, twice daily orally + finasteride 0.5mg twice daily, orally

Third Intervention (7 days)drug

Acyline 300mcg/kg subcutaneous + testosterone undecanoate 200 mg, twice daily orally + finasteride 1mg twice daily, orally

Second wash-out periodother

Washout of 7 days between each of the 3 treatment arms