Text Size

Trial of PED-1 in Male Patients With Premature Ejaculation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Symyoo
ClinicalTrials.gov Identifier:
NCT01439984
First received: September 18, 2011
Last updated: October 1, 2012
Last verified: October 2012
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by Symyoo:

Primary Outcome Measures:
  • Intravaginal ejaculation latency time (IELT)(seconds) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Drug coitus interval time (hours) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01439984

Locations
Korea, Republic of
National Health Insurance Corporation Ilsan Hospital
Goyang-si, Gyeonggi-do, Korea, Republic of
Inje University Ilsan Paik Hospital
Goyang-si, Gyeonggi-do, Korea, Republic of
Uijeongbu St.Marry's Hospital
Uijeongbu-si, Gyeonggi-do, Korea, Republic of
Seoul St.Marry's Hospital
Seoul, Korea, Republic of
Ewha Womans University Mokdong Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Symyoo
Investigators
Principal Investigator: Whan-Seok Choi, MD,PhD Seoul St. Marry's Hospital
  More Information

No publications provided

Responsible Party: Symyoo
ClinicalTrials.gov Identifier: NCT01439984     History of Changes
Other Study ID Numbers: CTC-PE-01
Study First Received: September 18, 2011
Last Updated: October 1, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Symyoo:
PE
IELT
DCIT

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Clomipramine
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
 Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013