- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01439984
Trial of PED-1 in Male Patients With Premature Ejaculation
October 1, 2012 updated by: Symyoo
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
The purpose of this study is to evaluate whether PED-1 is more effective than Placebo in the treatment of premature ejaculation.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
159
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of
- Ewha Womans University Mokdong Hospital
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Seoul, Korea, Republic of
- Seoul St.Marry's Hospital
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Gyeonggi-do
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Goyang-si, Gyeonggi-do, Korea, Republic of
- National Health Insurance Corporation Ilsan Hospital
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Goyang-si, Gyeonggi-do, Korea, Republic of
- Inje University Ilsan Paik Hospital
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Uijeongbu-si, Gyeonggi-do, Korea, Republic of
- Uijeongbu St.Marry's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: placebo
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Clomipramine 15 mg tablet or placebo tablet on demand for 12 weeks
Other Names:
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Experimental: PED-1
PED-1 (Clomipramine 15 mg)
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Clomipramine 15 mg tablet or placebo tablet on demand for 12 weeks
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Intravaginal ejaculation latency time (IELT)(seconds)
Time Frame: 12 weeks
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Drug coitus interval time (hours)
Time Frame: 12 weeks
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12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Whan-Seok Choi, MD,PhD, Seoul St. Marry's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
September 18, 2011
First Submitted That Met QC Criteria
September 22, 2011
First Posted (Estimate)
September 23, 2011
Study Record Updates
Last Update Posted (Estimate)
October 3, 2012
Last Update Submitted That Met QC Criteria
October 1, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pregnancy Complications
- Obstetric Labor Complications
- Sexual Dysfunctions, Psychological
- Obstetric Labor, Premature
- Sexual Dysfunction, Physiological
- Premature Birth
- Premature Ejaculation
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Antidepressive Agents, Tricyclic
- Clomipramine
Other Study ID Numbers
- CTC-PE-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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