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Trial of PED-1 in Male Patients With Premature Ejaculation

This study has been completed.
Information provided by (Responsible Party):
Symyoo Identifier:
First received: September 18, 2011
Last updated: October 1, 2012
Last verified: October 2012
The purpose of this study is to evaluate whether PED-1 is more effective than Placebo in the treatment of premature ejaculation.

Condition Intervention Phase
Premature Ejaculation
Drug: Clomipramine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Fixed Dose, Parallel Grouped, Multi-center Clinical Study to Evaluate the Safety and Efficacy of PED-1 in Male Patients With Premature Ejaculation

Resource links provided by NLM:

Further study details as provided by Symyoo:

Primary Outcome Measures:
  • Intravaginal ejaculation latency time (IELT)(seconds) [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Drug coitus interval time (hours) [ Time Frame: 12 weeks ]

Enrollment: 159
Study Start Date: September 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PED-1
PED-1 (Clomipramine 15 mg)
Drug: Clomipramine
Clomipramine 15 mg tablet or placebo tablet on demand for 12 weeks
Other Name: PED-1
Placebo Comparator: placebo Drug: Clomipramine
Clomipramine 15 mg tablet or placebo tablet on demand for 12 weeks
Other Name: PED-1

Detailed 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.

Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01439984

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
Uijeongbu St.Marry's Hospital
Uijeongbu-si, Gyeonggi-do, Korea, Republic of
Ewha Womans University Mokdong Hospital
Seoul, Korea, Republic of
Seoul St.Marry's Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Principal Investigator: Whan-Seok Choi, MD,PhD Seoul St. Marry's Hospital
  More Information

Responsible Party: Symyoo Identifier: NCT01439984     History of Changes
Other Study ID Numbers: CTC-PE-01
Study First Received: September 18, 2011
Last Updated: October 1, 2012

Keywords provided by Symyoo:

Additional relevant MeSH terms:
Premature Birth
Premature Ejaculation
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs processed this record on May 22, 2017