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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:
ClinicalTrials.gov Identifier:
NCT01203202
First Posted: September 16, 2010
Last Update Posted: October 3, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Symyoo
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:


Further study details as provided by Symyoo:

Primary Outcome Measures:
  • Fold cahnges of Intraviginal ejaculation latency time (IELT) [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • Drug coitus interval time [ Time Frame: 4 week ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Whan-Seok Choi, Seoul St. Marry's Hospital
ClinicalTrials.gov Identifier: NCT01203202     History of Changes
Other Study ID Numbers: CTC PE 02
First Submitted: September 14, 2010
First Posted: September 16, 2010
Last Update Posted: October 3, 2012
Last Verified: October 2012

Keywords provided by Symyoo:
PE
IELT
DCIT

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
Clomipramine
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