Trial of PED-1 in Male Patients With Premature Ejaculation
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
1 other identifier
interventional
159
1 country
5
Brief Summary
The purpose of this study is to evaluate whether PED-1 is more effective than Placebo in the treatment of premature ejaculation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2011
Shorter than P25 for phase_3
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 18, 2011
CompletedFirst Posted
Study publicly available on registry
September 23, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedOctober 3, 2012
October 1, 2012
9 months
September 18, 2011
October 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intravaginal ejaculation latency time (IELT)(seconds)
12 weeks
Secondary Outcomes (1)
Drug coitus interval time (hours)
12 weeks
Study Arms (2)
PED-1
EXPERIMENTALPED-1 (Clomipramine 15 mg)
placebo
PLACEBO COMPARATORInterventions
Clomipramine 15 mg tablet or placebo tablet on demand for 12 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Symyoolead
Study Sites (5)
Inje University Ilsan Paik Hospital
Goyang-si, Gyeonggi-do, South Korea
National Health Insurance Corporation Ilsan Hospital
Goyang-si, Gyeonggi-do, South Korea
Uijeongbu St.Marry's Hospital
Uijeongbu-si, Gyeonggi-do, South Korea
Ewha Womans University Mokdong Hospital
Seoul, South Korea
Seoul St.Marry's Hospital
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Whan-Seok Choi, MD,PhD
Seoul St. Marry's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2011
First Posted
September 23, 2011
Study Start
September 1, 2011
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
October 3, 2012
Record last verified: 2012-10