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The purpose of this study is to evaluate whether PED-1 is more effective than Placebo in the treatment of premature ejaculation.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PED-1 | Experimental | PED-1 (Clomipramine 15 mg) |
|
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clomipramine | Drug | Clomipramine 15 mg tablet or placebo tablet on demand for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intravaginal ejaculation latency time (IELT)(seconds) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Drug coitus interval time (hours) | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Whan-Seok Choi, MD,PhD | Seoul St. Marry's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje University Ilsan Paik Hospital | Goyang-si | Gyeonggi-do | South Korea | |||
| National Health Insurance Corporation Ilsan Hospital |
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| ID | Term |
|---|---|
| D061686 | Premature Ejaculation |
| ID | Term |
|---|---|
| D000097910 | Ejaculatory Dysfunction |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D002997 | Clomipramine |
| ID | Term |
|---|---|
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| 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 |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |