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Completed

NCT Number: NCT01439984

Trial of PED-1 in Male Patients With Premature Ejaculation

The purpose of this study is to evaluate whether PED-1 is more effective than Placebo in the treatment of premature ejaculation.

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Key information

Conditions

Premature Ejaculation Ejaculatory Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

20 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Inje University Ilsan Paik Hospital, Goyang-si, Gyeonggi-do, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clomipramine

Drug

Clomipramine 15 mg tablet or placebo tablet on demand for 12 weeks

Other names: PED-1

Primary outcomes

  1. Intravaginal ejaculation latency time (IELT)(seconds)

    Time frame: 12 weeks

Secondary outcomes

  1. Drug coitus interval time (hours)

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Symyoo

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 23, 2011
Registry last updated
Oct 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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