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Clinical Trial Summary

The purpose of this study is to assess the pharmacodynamics (the actions or effects a drug has on the body), pharmacokinetics (blood levels), safety, and tolerability of dapoxetine 60 mg when concomitantly administered in participants taking terazosin.


Clinical Trial Description

This is a multiple-center, randomized (participants are assigned to study drug by chance), multiple-dose, double-blind (neither physician nor participant knows the treatment assigned), placebo (inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial)-controlled, 2-period crossover (participants may receive different interventions sequentially during the trial) study to assess the pharmacodynamics, pharmacokinetics, safety, and tolerability of dapoxetine when concomitantly administered in adult male participants who have been on a stable dose of terazosin or doxazosin for at least 6 weeks. Study drugs used will be terazosin (a drug given for the treatment of hypertension and benign prostatic hyperplasia) and dapoxetine (a new drug being studied for the treatment of premature ejaculation). This study consists of a screening phase followed by a double-blind, placebo-controlled treatment phase consisting of 2 treatment periods. Participants will remain on their prescribed dose of terazosin and participants taking doxazosin will be converted to terazosin using the protocol-defined dose conversion (including assessment of control of urinary symptoms and risk for urinary retention). Participants will be administered concomitant (at the same time) dapoxetine or placebo once daily. Blood samples for pharmacodynamic and pharmacokinetic measurements will be collected at selected times during the study. Safety will be monitored. The total duration of study participation will be approximately 49 days. Participants will remain on their prescribed dose of terazosin (2 to 10 mg taken once daily by mouth) and will be administered daily by mouth concomitant dapoxetine 60 mg or placebo doses during 2 treatment periods (each 7 days in duration conducted in the study center). A period of up to 14 days will separate the treatment periods. ;


Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01366664
Study type Interventional
Source Janssen Research & Development, LLC
Contact
Status Completed
Phase Phase 1
Start date April 2011
Completion date April 2012

See also
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Completed NCT00210613 - A Study of Withdrawal Effects With Dapoxetine in the Treatment of Premature Ejaculation Phase 3
Completed NCT00211107 - A Study of the Effectiveness and Safety of Dapoxetine in the Treatment of Men With Premature Ejaculation. Phase 3
Completed NCT00219635 - Assessment Of Efficacy and Safety UK-390,957 In Men With Premature Ejaculation Phase 2/Phase 3
Completed NCT00219609 - Assessment Of Safety Of UK-390,957 Phase 2/Phase 3
Terminated NCT02918227 - Exploration of Ejaculation Changing Mechanism After Surgery for Benign Prostatic Hyperplasia N/A
Completed NCT00219583 - Assessment Of Efficacy and Safety Of UK-390,957 In Men With Premature Ejaculation Phase 2/Phase 3
Completed NCT00143117 - Assessment of Efficacy and Safety of UK-390,957 in Men With Premature Ejaculation Phase 2/Phase 3
Completed NCT01230762 - An Open-Label Study of the Long-Term Safety of Dapoxetine HCl in the Treatment of Rapid Ejaculation Phase 3
Completed NCT00211094 - A Study of the Effectiveness and Safety of Dapoxetine in the Treatment of Men With Premature Ejaculation Phase 3