Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01230762
Other study ID # CR005041
Secondary ID C-2002-014
Status Completed
Phase Phase 3
First received October 28, 2010
Last updated May 18, 2011
Est. completion date April 2005

Study information

Verified date January 2011
Source Alza Corporation, DE, USA
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


Description:

This is a multicenter, open-label (patients and Investigators will know the name of the drug that they are receiving) study to evaluate the long-term safety and efficacy of dapoxetine therapy in adult men with premature (rapid) ejaculation (PE) who participated in 1 of 2 previous studies of dapoxetine ( ALZA Protocol C-2002-012 or C-2002-013). The length of the study will be up to 9 months. During the study, patients will be monitored for safety by review of adverse events and findings from routine laboratory tests, vital signs measurements, electrocardiograms (ECGs), and physical examinations. Oral tablets of dapoxetine (30 mg or 60 mg) will be self-administered by patients once daily, as needed, for up to 9 months. No more than 1 dose within a 24-hour period should be taken. If the 60 mg dose of dapoxetine is not well tolerated, the dose may be decreased to 30 mg dapoxetine for the remainder of the study. Patients who do not tolerate the 30 mg dose of dapoxetine should be discontinued from the study.


Recruitment information / eligibility

Status Completed
Enrollment 1774
Est. completion date April 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

- Agreement by patient's sexual partner (if of childbearing potential) to ensure use of a medically acceptable method of contraception for the duration of the study Exclusion Criteria:

- 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Alza Corporation, DE, USA

Outcome

Type Measure Description Time frame Safety issue
Primary Adverse events reported Up to 9 months No
Primary Results from physical examinations Months 3 and 9 or termination visit No
Primary Results from vital signs measurements Months 1, 2 and 6 No
Primary Results from clinical laboratory tests Months 1, 3, and 9 or termination visit No
Primary Results from ECGs At the 3 month visit and the 9 month visit/Termination Visit No
Secondary Results from patient reported outcomes (PRO) for perception of sexual functioning During use of dapoxetine for up to 9 months No
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05366504 - LiST Plus PRP Injection Therapy vs LiST Monotherapy for ED Treatment Phase 2/Phase 3
Recruiting NCT02745808 - Injectable Collagen Scaffold™ Combined With HUC-MSCs for the Improvement of Erectile Function in Men With Diabetes Phase 1
Recruiting NCT02573805 - the Diagnostic Value of Rigiscan Test (Nocturnal Penile Tumescence and Rigidity, NPTR) in Chinese Males N/A
Withdrawn NCT01967251 - Efficacy, Safety and Dose-response of Udenafil in Patients With Benign Prostatic Hyperplasia and Erectile Dysfunction Phase 2
Withdrawn NCT02579148 - Collagen Scaffolds Loaded With HUCMSCs for the Improvement of Erectile Function in Men With Diabetes Phase 1
Recruiting NCT02225548 - Sagene 2014 - Parkinson's Disease and Erectile Dysfunction Phase 4
Completed NCT02587988 - Trial to Evaluate the Efficacy and Safety of HCP1302 Phase 3
Completed NCT01937871 - A Study of Tadalafil in Men With Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED) Phase 3
Completed NCT02945462 - Bone Marrow Mesenchymal Stem Cells in Erectile Dysfunction (ED) Phase 1
Completed NCT01698684 - Research Evaluating a PDE5 Inhibitor for Erectile Dysfunction Phase 4
Not yet recruiting NCT01321489 - A Study to Evaluate a Possible Superiority Expressed by the Faster Onset of Action and the Efficacy and Safety of Sildenafil Citrate 20mg Sublingual Tablet in the Treatment of Erectile Dysfunction of Different Etiologies Phase 3
Completed NCT01230541 - Effect of Udenafil on Spermatogenesis Phase 1
Completed NCT02226237 - Effectiveness of Physiotherapy to Treat the Urinary Incontinence and Erectile Dysfunction Post Retropubic Prostatectomy N/A
Terminated NCT01262833 - Pudendal Assessment in Erectile Dysfunction N/A
Completed NCT01037218 - Treatment of Erectile Dysfunction II Phase 3
Completed NCT01037244 - Treatment of Erectile Dysfunction I Phase 3
Recruiting NCT00313898 - Effect of Sildenafil on Quality of Sexual Life in Mild to Normally Sexually Functioning Males Phase 4
Completed NCT00663728 - Assessment of Duration of Erection With Vardenafil 10 mg Phase 4
Completed NCT00421083 - Efficacy and Safety of Tadalafil in Subjects With Erectile Dysfunction Caused by Spinal Cord Injury Phase 3
Completed NCT00667979 - Evaluating the Efficacy of Vardenafil in Subjects With Erectile Dysfunction (ED) Administered 12, 18 or 24 Hours Prior to Intercourse Phase 4