Phase 2 Trial of PED-1 and PED-2 in Male Patients With Premature Ejaculation
NCT ID: NCT01203202
Last Updated: 2012-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
104 participants
INTERVENTIONAL
2010-09-30
2011-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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PED 0
placebo
Clomipramine
15mg and 30mg on demand
PED 1
PED-1 (clomipramine 15mg)
Clomipramine
15mg and 30mg on demand
PED-2
PED-2 (Clomipramine 30mg)
Clomipramine
15mg and 30mg on demand
Interventions
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Clomipramine
15mg and 30mg on demand
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* erectile dysfunction (\<21 IIEF EF domain score) or other forms of sexual dysfunction
* Partner sexual dysfunction
* known hypersensitivity to clomipramine and contraindications for clomipramine
20 Years
65 Years
MALE
No
Sponsors
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Symyoo
INDUSTRY
Responsible Party
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Seoul St. Marry's Hospital
Principal Investigators
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Whan-Seok Choi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul St. Marry's Hospital
Locations
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Ewha University Mok-dong Hospital
Seoul, , South Korea
Seoul St. Marry's Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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CTC PE 02
Identifier Type: -
Identifier Source: org_study_id
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