At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 20 target
Drug / intervention
Ertapenemdrug
Likely dose
Ertapenem 1gfrom 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.
Assessment of Prostatic Tissue Concentration of Ertapenem After a Pre-operative Administration
In Brief
A Phase 4 clinical trial evaluating Ertapenem for Benign Prostatic Hyperplasia (BPH) Requiring Surgical Resection. Completed, enrolled 20 participants across 1 site.
Detailed Summary
The purpose of this study is to demonstrate the prostatic diffusion in significant concentration of ertapenem achieved after a pre-operative single administration.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
CollaboratorsMerck Sharp & Dohme LLC, URC-CIC Paris Descartes Necker Cochin
Timeline
Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartDec 2013
First PostedJan 2014
Primary CompletionJan 2015
Study CompletionJun 2015
TodayJul 2026
First PostedJan 22, 2014
Enrollment StartDec 1, 2013
Primary CompletionJan 1, 2015
Study CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 12.4 years ago
Interventions
Ertapenemdrug
One single injection of 1g of ertapenem before surgery