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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01439984
Other study ID # CTC-PE-01
Secondary ID
Status Completed
Phase Phase 3
First received September 18, 2011
Last updated October 1, 2012
Start date September 2011
Est. completion date June 2012

Study information

Verified date October 2012
Source Symyoo
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate whether PED-1 is more effective than Placebo in the treatment of premature ejaculation.


Description:

This study is to evaluate whether PED-1 is effective than Placebo in the treatment of premature ejaculation. The patients will be randomized and allocated to two treatment groups into placebo, PED-1. The criteria for Intravaginal Ejaculation Latency Time(IELT) for enrollment will be > or =2 min in the at least 75% of the sexual intercourse. To diagnosis premature ejaculation, the PEDT(Premature Ejaculation Diagnosis Tool) will be used. The patients undergone drug free baseline period will take test drugs for 12 weeks.


Recruitment information / eligibility

Status Completed
Enrollment 159
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Male
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria:

- Informed consent for subjects and partners

- Men 20-65 ages

- Stable monogamous relation at least for 6 mo

- Premature Ejaculation Diagnosis Tool (PEDT) more than 9

- At least 6 mo of premature ejaculation Hx

- IELT of =< 2 min in >= 75% of evaluable events during 4 week screening period

Exclusion Criteria:

- History of medical or psychiatric illness

- Erectile dysfunction (<21 International Index of Erectile Function-Erectile Function (IIEF-EF) domain score) or other forms of sexual dysfunction

- Partner sexual dysfunction

- Known hypersensitivity to clomipramine and contraindications for clomipramine

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Clomipramine
Clomipramine 15 mg tablet or placebo tablet on demand for 12 weeks

Locations

Country Name City State
Korea, Republic of Inje University Ilsan Paik Hospital Goyang-si Gyeonggi-do
Korea, Republic of National Health Insurance Corporation Ilsan Hospital Goyang-si Gyeonggi-do
Korea, Republic of Ewha Womans University Mokdong Hospital Seoul
Korea, Republic of Seoul St.Marry's Hospital Seoul
Korea, Republic of Uijeongbu St.Marry's Hospital Uijeongbu-si Gyeonggi-do

Sponsors (1)

Lead Sponsor Collaborator
Symyoo

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intravaginal ejaculation latency time (IELT)(seconds) 12 weeks No
Secondary Drug coitus interval time (hours) 12 weeks No
See also
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Completed NCT01203202 - Phase 2 Trial of PED-1 and PED-2 in Male Patients With Premature Ejaculation Phase 2
Completed NCT01184105 - A Safety and Tolerability of PSD502 (a Topical Anesthetic) in the Treatment of Premature Ejaculation Phase 1
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Completed NCT02572037 - Research and Clinical Value of New Classification for Premature Ejaculation: Multi-Center Research
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Terminated NCT00983736 - Study to Evaluate Efficacy and Safety in Male Subjects With Premature Ejaculation Phase 3
Completed NCT00549211 - A First Time in Human Study in Healthy Male Volunteers for Compound GSK557296. Phase 1
Completed NCT00556478 - Efficacy, Safety and Tolerability of PSD502 (a Topical Anesthetic) in the Treatment Premature Ejaculation Phase 2/Phase 3
Not yet recruiting NCT05556083 - Sildenafil Added Effect in Dapoxetine Non-responding Mono-symptomatic Premature Ejaculation (PE) Phase 2
Completed NCT03304808 - Efficacy of a New Behavioral Treatment for Premature Ejaculation Using a Masturbation Aid Device: Star-Stop 3.0 N/A
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Recruiting NCT02571101 - A Phase 2 Study of On-demand Therapy With Clomipramine and Sildenafil Combination in Premature Ejaculation Phase 2
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Completed NCT02794454 - A Study to Evaluate Efficacy of Investigational Product HeezOn Ultra -1/ HeezOn Ultra-2 on Male Sexual Health N/A
Completed NCT02297152 - A New Treatment for Premature Ejaculation? N/A
Not yet recruiting NCT00656552 - Safety and Efficacy of Escitalopram in the Treatment of Premature Ejaculation Phase 0
Recruiting NCT04703127 - Effectiveness and Tolerability of the On-demand Use of Combined Dapoxetine With Tadalafil and Combined Dapoxetine With Lidocaine 5% Spray in Treatment of Patients With Lifelong Premature Ejaculation and Non-responding to Dapoxetine Alone. Phase 3