NCT01203202

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

October 3, 2012

Status Verified

October 1, 2012

Enrollment Period

4 months

First QC Date

September 14, 2010

Last Update Submit

October 1, 2012

Conditions

Premature Ejaculation

Keywords

PEIELTDCIT

Outcome Measures

Primary Outcomes (1)

  • Fold cahnges of Intraviginal ejaculation latency time (IELT)

    4 weeks

Secondary Outcomes (1)

  • Drug coitus interval time

    4 week

Study Arms (3)

PED 0

PLACEBO COMPARATOR

placebo

Drug: Clomipramine

PED 1

EXPERIMENTAL

PED-1 (clomipramine 15mg)

Drug: Clomipramine

PED-2

EXPERIMENTAL

PED-2 (Clomipramine 30mg)

Drug: Clomipramine

Interventions

ClomipramineDRUG

15mg and 30mg on demand

Also known as: PED-1, PED-2
PED 0PED 1PED-2

Eligibility Criteria

Age20 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ewha University Mok-dong Hospital

Seoul, South Korea

Location

Seoul St. Marry's Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Premature Ejaculation

Interventions

Clomipramine

Condition Hierarchy (Ancestors)

Ejaculatory DysfunctionGenital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

DibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Whan-Seok Choi, MD, PhD

    Seoul St. Marry's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 14, 2010

First Posted

September 16, 2010

Study Start

September 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

October 3, 2012

Record last verified: 2012-10

Locations

KR(2)