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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

September 14, 2010
October 1, 2012
September 2010
January 2011   (final data collection date for primary outcome measure)
Fold cahnges of Intraviginal ejaculation latency time (IELT) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01203202 on ClinicalTrials.gov Archive Site
Drug coitus interval time [ Time Frame: 4 week ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Phase 2 Trial of PED-1 and PED-2 in Male Patients With Premature Ejaculation
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

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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Premature Ejaculation
Drug: Clomipramine
15mg and 30mg on demand
Other Names:
  • PED-1
  • PED-2
  • Placebo Comparator: PED 0
    placebo
    Intervention: Drug: Clomipramine
  • Experimental: PED 1
    PED-1 (clomipramine 15mg)
    Intervention: Drug: Clomipramine
  • Experimental: PED-2
    PED-2 (Clomipramine 30mg)
    Intervention: Drug: Clomipramine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
104
January 2011
January 2011   (final data collection date for primary outcome measure)

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
Male
20 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01203202
CTC PE 02
No
Whan-Seok Choi, Seoul St. Marry's Hospital
Symyoo
Not Provided
Principal Investigator: Whan-Seok Choi, MD, PhD Seoul St. Marry's Hospital
Symyoo
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP