A Phase 2 Study of On-demand Therapy With Clomipramine and Sildenafil Combination in Premature Ejaculation
NCT ID: NCT02571101
Last Updated: 2015-12-17
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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UNKNOWN
PHASE2
297 participants
INTERVENTIONAL
2015-11-30
2016-06-30
Brief Summary
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Detailed Description
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The efficacy of oral administration of Clomipramine HCl will be investigated closely compared to the effects after oral administration of CDFR0812-15/25mg and CDFR0812-15/50mg.
The secondary object is to investigate general safety of oral administration of CDFR0812-15/25mg and CDFR0812-15/50mg.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Test 1
Test 1 subjects will take one tablet of CDFR0812-15/25mg and another tablet of Condencia-Placebo before sexual intercourse in on-demand for 8 weeks.
CDFR0812-15/25mg
Contains chlomipramine HCl 15mg and sildenafil citrate 25mg.
Condencia-Placebo
Placebo tablet of Condencia
Test 2
Test 2 subjects will take one tablet of CDFR0812-15/50mg and another tablet of Condencia-Placebo before sexual intercourse in on-demand for 8 weeks.
CDFR0812-15/50mg
Contains chlomipramine HCl 15mg and sildenafil citrate 50mg.
Condencia-Placebo
Placebo tablet of Condencia
Comparator
Comparator subjects will take one tablet of Condencia and another tablet of CDFR0812-Placebo before sexual intercourse in on-demand for 8 weeks.
Condencia
Contains chlomipramine HCl 15mg.
CDFR0812-Placebo
Placebo tablet of CDFR0812.
Interventions
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CDFR0812-15/25mg
Contains chlomipramine HCl 15mg and sildenafil citrate 25mg.
CDFR0812-15/50mg
Contains chlomipramine HCl 15mg and sildenafil citrate 50mg.
Condencia
Contains chlomipramine HCl 15mg.
CDFR0812-Placebo
Placebo tablet of CDFR0812.
Condencia-Placebo
Placebo tablet of Condencia
Eligibility Criteria
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Inclusion Criteria
* Both patient and his partner given their informed and written consents
* Patient who has persisted for at least 6 months and is willing to retain the relationship during this study
* Patient diagnosed with premature ejaculation according to DSM-V
* Patient whose score in PEDT (Korean version) is 11 and more
* Patient who are willing to try 4 and more intercourse attempts for Run-in period and he has experienced 75%-100% of the IELT within one minute or less of vaginal penetration
* Patient whose personal distress in PEP is 'moderate' and over.
* Patient who is willing to participate in the study by the end and are cooperative (trying 4 and more intercourse attempts between each visit and able to postpone scheduled elective surgery)
* Patient who is willing to complete a patient diary and questionnaires
Exclusion Criteria
* Patient who has participated into other trials within 90 days before this study
* Patient who is in a unstable medical condition or has alcohol/drug abuse in recent 6 months
* Patient whose female partner is less interested in sexual intercourse or has a sexual disorder
* Patient whose female partner is pregnant
* Patient whose female partner of childbearing age is not willing to use proper birth control
* Patient whose IIEF-EF score is 25 and less
* Medical history of convulsive diseases, mental diseases, E.C.T (Electroconvulsive shock Treatment), glaucoma
* Patient who has taken concomitantly prohibited medicines before the study and who is not willing to stop the medications for appropriate wash-out period
19 Years
65 Years
MALE
No
Sponsors
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Symyoo
INDUSTRY
CTC Bio, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Hwan-Seok Choi, M.D, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Catholic Medical Center Seoul St. Mary's Hospital
Sae Woong Kim, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Catholic Medical Center Seoul St. Mary's Hospital
Locations
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Inje University Ilsan Paik Hospital
Goyang-si, , South Korea
National Health Insurance Service Ilsan Hospital
Goyang-si, , South Korea
Pusan National University Hospital
Pusan, , South Korea
Catholic Medical Center Seoul St. Mary's Hospital
Seoul, , South Korea
Ewha Womans University Medical Center
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Catholic university of Korea Uijeongbu St.Mary's Hospital
Uijeongbu-si, , South Korea
Countries
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Central Contacts
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Other Identifiers
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CTC-PED-CDFR0812_P2
Identifier Type: -
Identifier Source: org_study_id