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Phase 2 Trial of PED-1 and PED-2 in Male Patients With Premature Ejaculation

This study has been completed.
Sponsor:
Information provided by:
Symyoo
ClinicalTrials.gov Identifier:
NCT01203202
First received: September 14, 2010
Last updated: October 1, 2012
Last verified: October 2012
History of Changes
  Purpose

The purpose of this study is to evaluate whether PED-1 (15mg) and PED-2 (30mg) are tolerable and effective in the treatment of premature ejaculation.


Condition Intervention Phase
Premature Ejaculation
 Drug: Clomipramine
 Phase 2

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 Clinical Study to Evaluate the Tolerability and to Determine the Adequate Dosage of PED-1 and PED-2 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:
  • Fold cahnges of Intraviginal ejaculation latency time (IELT) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Drug coitus interval time [ Time Frame: 4 week ] [ Designated as safety issue: No ]

Enrollment: 104
Study Start Date: September 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: PED 0
placebo
 Drug: Clomipramine
15mg and 30mg on demand
Other Names:
  • PED-1
  • PED-2
Experimental: PED 1
PED-1 (clomipramine 15mg)
 Drug: Clomipramine
15mg and 30mg on demand
Other Names:
  • PED-1
  • PED-2
Experimental: PED-2
PED-2 (Clomipramine 30mg)
 Drug: Clomipramine
15mg and 30mg on demand
Other Names:
  • PED-1
  • PED-2

Detailed Description:

This study is to evaluate whether PED-1 and PED2 are tolerable and effective in the treatment of premature ejaculation. The patients will be randomized and allocated to three treatment groups into placebo, PED-1, and PED-2. The creteria for IELT for enrollment will be > or =2 min in the at least 75% of the sexual intercourse. To diagnosis premature ejaculation, the PEDT will be used. The patients ungone drug free baseline line period will take test drugs for 4 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 partdners
  • Men 20-65
  • stable monogamous relation at least for 6 mn
  • PEDT more than 9
  • at least 6 Mn of premature ejaculation Hx
  • IELT of =< 2 min in >= 75% of evaluable events during 4 week secreening period

Exclusion Criteria:

  • Hx of medical or psychiartric illness
  • erectile dysfunction (<21 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: NCT01203202

Locations
Korea, Republic of
Ewha University Mok-dong Hospital
Seoul, Korea, Republic of
Seoul St. Marry's 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: Whan-Seok Choi, Seoul St. Marry's Hospital
ClinicalTrials.gov Identifier: NCT01203202     History of Changes
Other Study ID Numbers: CTC PE 02
Study First Received: September 14, 2010
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 23, 2013