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A Phase 2 Study of On-demand Therapy With Clomipramine and Sildenafil Combination in Premature Ejaculation

NCT02571101 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 297

Last updated 2015-12-17

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of on-demand therapy with CDFR0812-15/25mg and CDFR0812-15/50mg compared to on-demand therapy with single-drug administration of Clomipramine HCl 15mg in Korean Male Patients Diagnosed with Premature Ejaculation

Conditions

  • Premature Ejaculation

Interventions

DRUG

CDFR0812-15/25mg

Contains chlomipramine HCl 15mg and sildenafil citrate 25mg.

DRUG

CDFR0812-15/50mg

Contains chlomipramine HCl 15mg and sildenafil citrate 50mg.

DRUG

Condencia

Contains chlomipramine HCl 15mg.

DRUG

CDFR0812-Placebo

Placebo tablet of CDFR0812.

DRUG

Condencia-Placebo

Placebo tablet of Condencia

Sponsors & Collaborators

  • Symyoo

    collaborator INDUSTRY

  • CTC Bio, Inc.

    lead INDUSTRY

Principal Investigators

  • Hwan-Seok Choi, M.D, Ph.D. · Catholic Medical Center Seoul St. Mary's Hospital

  • Sae Woong Kim, M.D., Ph.D. · Catholic Medical Center Seoul St. Mary's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-05-31
Completion
2016-06-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02571101 on ClinicalTrials.gov