Trial of PED-1 in Male Patients With Premature Ejaculation
Information source: Symyoo
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Premature Ejaculation
Intervention: Clomipramine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Symyoo Official(s) and/or principal investigator(s): Whan-Seok Choi, MD,PhD, Principal Investigator, Affiliation: Seoul St. Marry's Hospital
Summary
The purpose of this study is to evaluate whether PED-1 is more effective than Placebo in the
treatment of premature ejaculation.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Intravaginal ejaculation latency time (IELT)(seconds)
Secondary outcome: Drug coitus interval time (hours)
Detailed description:
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.
Eligibility
Minimum age: 20 Years.
Maximum age: 65 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Locations and Contacts
Ewha Womans University Mokdong Hospital, Seoul, Korea, Republic of
Seoul St.Marry's Hospital, Seoul, Korea, Republic of
Inje University Ilsan Paik Hospital, Goyang-si, Gyeonggi-do, Korea, Republic of
National Health Insurance Corporation Ilsan Hospital, Goyang-si, Gyeonggi-do, Korea, Republic of
Uijeongbu St.Marry's Hospital, Uijeongbu-si, Gyeonggi-do, Korea, Republic of
Additional Information
Starting date: September 2011
Last updated: October 1, 2012
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