Status unknownNCT02571101Updated Dec 17, 2015

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

A Phase 2 interventional study of CDFR0812-15/25mg and CDFR0812-15/50mg in Premature Ejaculation, sponsored by CTC Bio, Inc.. Status unknown at 9 sites in Korea, Republic of. Open to male participants aged 19 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-12-17.

Sponsored by CTC Bio, Inc. · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2015), so the status shown — last known as Recruiting — may be out of date.

Phase: Phase 2
Study type: Interventional
Enrollment: 297
Allocation: Randomized
Ages: 19 Years to 65 Years
Sex: Male

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

Read the detailed description

Clomipramine is a dibenzazepine-derivative tricyclic antidepressant (TCA) and is a potent inhibitor of serotonin and norepinephrine reuptake. Clomipramine may be used in a variety of indications. Condencia Tab contains low dose of 15mg of clomipramine HCl as an active ingredient, which is newly approved to market for the treatment of premature ejaculation. This study is a prospective, randomized, double-blinded, active-control, 3-treatment arm, parallel, multi-center clinical trial. Approximately a total of 297 male patients diagnosed with premature ejaculation will be enrolled and randomized into 3 groups (99 subjects per a group).

The efficacy of oral administration of Clomipramine HCl will be investigated closely compared to the effects after oral administration of CDFR0812-15/25mg and CDFR0812-15/50mg.

The secondary object is to investigate general safety of oral administration of CDFR0812-15/25mg and CDFR0812-15/50mg.

Conditions studied

Premature Ejaculation

Browse trials for

Keywords

Clomipramine
Premature ejaculation
CDFR0812
Sildenafil

In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's planned enrollment of 297 is above the median of 84 across 1,689 interventional studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

CTC Bio, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 19 Years to 65 Years
Sexes eligible: Male
Accepts healthy volunteers: No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 297 participants (estimated)

Study arms

Experimental
Test 1
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
Experimental
Test 2
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
Placebo comparator
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

DrugCDFR0812-15/25mg
Contains chlomipramine HCl 15mg and sildenafil citrate 25mg.
DrugCDFR0812-15/50mg
Contains chlomipramine HCl 15mg and sildenafil citrate 50mg.
DrugCondencia
Contains chlomipramine HCl 15mg.
DrugCDFR0812-Placebo
Placebo tablet of CDFR0812.
DrugCondencia-Placebo
Placebo tablet of Condencia

What researchers measure

Primary outcomes

The fold change of IELT
IELT(Intravaginal Ejaculation Latency Time), which is to be reported through patient diary
Time frame: From 4 weeks to 8 weeks after dosing

Secondary outcomes

The % change of IELT
IELT(Intravaginal Ejaculation Latency Time), which is to be reported through patient diary
Time frame: From 4 weeks to 8 weeks after dosing
The mean change of IELT
IELT(Intravaginal Ejaculation Latency Time), which is to be reported through patient diary
Time frame: From 4 weeks to 8 weeks after dosing
The response rate
PEP (Premature Ejaculation Profile) questionnaire
Time frame: At 8 weeks after dosing
Global impression reported by patient
PGIG (Patient Global Impression of Change in Premature Ejaculation)
Time frame: At 8 weeks after dosing
Administration time of study drug
The time when a patient takes study drug before sexual attempt
Time frame: for 8 weeks
Number of patients with adverse events
It will be assessed by CTCAE v4.03
Time frame: for 8 weeks

Study locations

8 of 9 sites recruiting

Inje University Ilsan Paik Hospital
Goyang-si, Korea, Republic of
Recruiting
National Health Insurance Service Ilsan Hospital
Goyang-si, Korea, Republic of
Recruiting
Pusan National University Hospital
Pusan, Korea, Republic of
Recruiting
Catholic Medical Center Seoul St. Mary's Hospital
Seoul, Korea, Republic of
Recruiting
Ewha Womans University Medical Center
Seoul, Korea, Republic of
Recruiting
Korea University Guro Hospital
Seoul, Korea, Republic of
Recruiting
Samsung Medical Center
Seoul, Korea, Republic of
Recruiting
Seoul National University Hospital
Seoul, Korea, Republic of
Recruiting
Catholic university of Korea Uijeongbu St.Mary's Hospital
Uijeongbu-si, Korea, Republic of
Not yet recruiting

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 17, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02571101
Lead sponsor: CTC Bio, Inc.
Collaborators: Symyoo
Responsible party: Sponsor
First posted: Oct 8, 2015
Start date: Nov 2015
Primary completion: May 2016 (estimated)
Completion: Jun 2016 (estimated)
Last update: Dec 17, 2015

Study contacts

Youngrang Lee

Contact

yrlee@symyoo.com

82-(0)70-4335-4759

Hwan-Seok Choi, M.D, Ph.D.

principal investigator · Catholic Medical Center Seoul St. Mary's Hospital

Sae Woong Kim, M.D., Ph.D.

principal investigator · Catholic Medical Center Seoul St. Mary's Hospital

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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