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

NCT02571101 | Unknown Phase 2

• 1 other identifier: CTC-PED-CDFR0812_P2
• Study Type: interventional
• Target: 297
• Locations: 1 country
• Sites: 9

Brief 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

Keywords

Clomipramine; Premature ejaculation; CDFR0812; Sildenafil

Outcome Measures

Primary Outcomes (1)

• The fold change of IELT

  IELT(Intravaginal Ejaculation Latency Time), which is to be reported through patient diary

  From 4 weeks to 8 weeks after dosing

Secondary Outcomes (6)

• The % change of IELT

  From 4 weeks to 8 weeks after dosing

• The mean change of IELT

  From 4 weeks to 8 weeks after dosing

• The response rate

  At 8 weeks after dosing

• Global impression reported by patient

  At 8 weeks after dosing

• Administration time of study drug

  for 8 weeks

Study Arms (3)

Test 1

EXPERIMENTAL

Test 1 subjects will take one tablet of CDFR0812-15/25mg and another tablet of Condencia-Placebo before sexual intercourse in on-demand for 8 weeks.

Drug: CDFR0812-15/25mg; Drug: Condencia-Placebo

Test 2

EXPERIMENTAL

Test 2 subjects will take one tablet of CDFR0812-15/50mg and another tablet of Condencia-Placebo before sexual intercourse in on-demand for 8 weeks.

Drug: CDFR0812-15/50mg; Drug: Condencia-Placebo

Comparator

PLACEBO COMPARATOR

Comparator subjects will take one tablet of Condencia and another tablet of CDFR0812-Placebo before sexual intercourse in on-demand for 8 weeks.

Drug: Condencia; Drug: CDFR0812-Placebo

Interventions

CDFR0812-15/25mg DRUG

Contains chlomipramine HCl 15mg and sildenafil citrate 25mg.

Test 1

CDFR0812-15/50mg DRUG

Contains chlomipramine HCl 15mg and sildenafil citrate 50mg.

Test 2

Condencia DRUG

Contains chlomipramine HCl 15mg.

Comparator

CDFR0812-Placebo DRUG

Placebo tablet of CDFR0812.

Comparator

Condencia-Placebo DRUG

Placebo tablet of Condencia

Test 1; Test 2

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Korean male aged between 19 and 65
• Both patient and his partner given their informed and written consents
• Patient who has persisted for at least 6 months and is willing to retain the relationship during this study
• Patient diagnosed with premature ejaculation according to DSM-V
• Patient whose score in PEDT (Korean version) is 11 and more
• Patient who are willing to try 4 and more intercourse attempts for Run-in period and he has experienced 75%-100% of the IELT within one minute or less of vaginal penetration
• Patient whose personal distress in PEP is 'moderate' and over.
• Patient who is willing to participate in the study by the end and are cooperative (trying 4 and more intercourse attempts between each visit and able to postpone scheduled elective surgery)
• Patient who is willing to complete a patient diary and questionnaires

You may not qualify if:

• Patient who has a medical history including neurological disorders, infectious diseases, damage, surgery or medication history and that is judged to be related to premature ejaculation
• Patient who has participated into other trials within 90 days before this study
• Patient who is in a unstable medical condition or has alcohol/drug abuse in recent 6 months
• Patient whose female partner is less interested in sexual intercourse or has a sexual disorder
• Patient whose female partner is pregnant
• Patient whose female partner of childbearing age is not willing to use proper birth control
• Patient whose IIEF-EF score is 25 and less
• Medical history of convulsive diseases, mental diseases, E.C.T (Electroconvulsive shock Treatment), glaucoma
• Patient who has taken concomitantly prohibited medicines before the study and who is not willing to stop the medications for appropriate wash-out period

Sponsors & Collaborators

• CTC Bio, Inc.: lead
• Symyoo: collaborator

Study Sites (9)

Inje University Ilsan Paik Hospital

Goyang-si, South Korea

RECRUITING

National Health Insurance Service Ilsan Hospital

Goyang-si, South Korea

RECRUITING

Pusan National University Hospital

Pusan, South Korea

RECRUITING

Catholic Medical Center Seoul St. Mary's Hospital

Seoul, South Korea

RECRUITING

Ewha Womans University Medical Center

Seoul, South Korea

RECRUITING

Korea University Guro Hospital

Seoul, South Korea

RECRUITING

Samsung Medical Center

Seoul, South Korea

RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Catholic university of Korea Uijeongbu St.Mary's Hospital

Uijeongbu-si, South Korea

NOT YET RECRUITING

MeSH Terms

Conditions

Premature Ejaculation

Condition Hierarchy (Ancestors)

Ejaculatory Dysfunction; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Hwan-Seok Choi, M.D, Ph.D.

  Catholic Medical Center Seoul St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

• Sae Woong Kim, M.D., Ph.D.

  Catholic Medical Center Seoul St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Youngrang Lee

CONTACT

82-(0)70-4335-4759; yrlee@symyoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2015
• First Posted: October 8, 2015
• Study Start: November 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: December 17, 2015

Record last verified: 2015-12

Locations

KR (9)