NCT01230762

Brief Summary

The purpose of this study is to evaluate the long-term safety of dapoxetine in men with rapid ejaculation.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,774

participants targeted

Target at P75+ for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

October 28, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 29, 2010

Completed
Last Updated

May 19, 2011

Status Verified

January 1, 2011

First QC Date

October 28, 2010

Last Update Submit

May 18, 2011

Conditions

EjaculationErectile DysfunctionSexual Dysfunction

Keywords

Dapoxetine, Orgasmic disorderPremature ejaculationSexual dysfunctionSexual intercourseEjaculationErectile Dysfunction

Outcome Measures

Primary Outcomes (5)

  • Adverse events reported

    Up to 9 months

  • Results from physical examinations

    Months 3 and 9 or termination visit

  • Results from vital signs measurements

    Months 1, 2 and 6

  • Results from clinical laboratory tests

    Months 1, 3, and 9 or termination visit

  • Results from ECGs

    At the 3 month visit and the 9 month visit/Termination Visit

Secondary Outcomes (1)

  • Results from patient reported outcomes (PRO) for perception of sexual functioning

    During use of dapoxetine for up to 9 months

Study Arms (1)

001

EXPERIMENTAL

dapoxetine 60 mg tablet once daily as needed (prn) (with a possible dose reduction to 30 mg once daily) for up to 9 months

Drug: dapoxetine

Interventions

dapoxetineDRUG

60 mg tablet once daily as needed (prn) (with a possible dose reduction to 30 mg once daily) for up to 9 months

001

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Enrollment within 30 days of completion of 1 of the 2 Phase 3 controlled studies (ALZA Study C-2002-012 or Study C-2002-013)
  • In the opinion of the Investigator, the patient could safely continue the use of dapoxetine treatment
  • Had a systolic blood pressure of \<=180 mm Hg and a diastolic blood pressure \<=100 mm Hg

You may not qualify if:

  • Currently taking any any protocol-defined prohibited medications
  • Reported a diagnosis of any sexually transmitted disease, Had a new allergy or hypersensitivity to dapoxetine or other selective serotonin reuptake inhibitors
  • In the opinion of the Investigator is incapable of following the study schedule for any reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Erectile DysfunctionSexual Dysfunction, PhysiologicalSexual Dysfunctions, PsychologicalPremature EjaculationCoitus

Interventions

dapoxetine

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesMental DisordersEjaculatory DysfunctionSexual BehaviorBehavior

Study Officials

  • Alza Corporation Clinical Trial

    ALZA

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 28, 2010

First Posted

October 29, 2010

Study Completion

April 1, 2005

Last Updated

May 19, 2011

Record last verified: 2011-01