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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

Page last updated: August 23, 2015

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