Premature EjaculationPhase 2NCT02571101
A Phase 2 Study of On-demand Therapy With Clomipramine and Sildenafil Combination in Premature Ejaculation
A Phase 2 study testing CDFR0812-15/25mg, CDFR0812-15/50mg and Condencia in people with Premature Ejaculation, run by CTC Bio, Inc. at 9 sites in South Korea.
Trial 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 more about this study
- Who is it for?
- Ages 19 to 65 years, men only
- Conditions the study is for
- Premature Ejaculation
- What is being tested?
- CDFR0812-15/25mg, CDFR0812-15/50mg and Condencia
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 297 participants
- Where
- 9 sitesSouth Korea
- Study dates
- Nov 2015to Jun 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
South Korea9 sites, 9 recruiting
- Recruiting
Inje University Ilsan Paik Hospital
Goyang-si
- Recruiting
National Health Insurance Service Ilsan Hospital
Goyang-si
- Recruiting
Pusan National University Hospital
Pusan
- Recruiting
Catholic Medical Center Seoul St. Mary's Hospital
Seoul
- Recruiting
Ewha Womans University Medical Center
Seoul
- Recruiting
Korea University Guro Hospital
Seoul
- Recruiting
Samsung Medical Center
Seoul
- Recruiting
Seoul National University Hospital
Seoul
- Not yet recruiting
Catholic university of Korea Uijeongbu St.Mary's Hospital
Uijeongbu-si
About this study
Official title: A Prospective, Randomized, Double-blinded, Active-control, 3-Treatment Arm, Parallel, Multi-center, Phase 2 Trial to Evaluate Safety and Efficacy With CDFR0812-15/25mg and CDFR0812-15/50mg Compared to Clomipramine HCl 15mg in Male Patients Diagnosed With Premature Ejaculation
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
- Premature Ejaculation
- Being tested
- CDFR0812-15/25mg, CDFR0812-15/50mg, Condencia, CDFR0812-Placebo, Condencia-Placebo
- Keywords
- Clomipramine, Premature ejaculation, CDFR0812, Sildenafil
- Medical subject headings
- Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDFR0812-15/25mgDrug
Contains chlomipramine HCl 15mg and sildenafil citrate 25mg.
CDFR0812-15/50mgDrug
Contains chlomipramine HCl 15mg and sildenafil citrate 50mg.
CondenciaDrug
Contains chlomipramine HCl 15mg.
CDFR0812-PlaceboDrug
Placebo tablet of CDFR0812.
Condencia-PlaceboDrug
Placebo tablet of Condencia
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Condencia; Drug: CDFR0812-Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The fold change of IELT
IELT(Intravaginal Ejaculation Latency Time), which is to be reported through patient diary
Measured: From 4 weeks to 8 weeks after dosing
Secondary outcomes (6)
The % change of IELT
IELT(Intravaginal Ejaculation Latency Time), which is to be reported through patient diary
Measured: 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
Measured: From 4 weeks to 8 weeks after dosing
The response rate
PEP (Premature Ejaculation Profile) questionnaire
Measured: At 8 weeks after dosing
Global impression reported by patient
PGIG (Patient Global Impression of Change in Premature Ejaculation)
Measured: At 8 weeks after dosing
Administration time of study drug
The time when a patient takes study drug before sexual attempt
Measured: for 8 weeks
Number of patients with adverse events
It will be assessed by CTCAE v4.03
Measured: for 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionMay 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature EjaculationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 297 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CTC Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Symyoo
- Responsible party
- Sponsor
- Investigators
- Hwan-Seok Choi, M.D, Ph.D., Principal investigator, Catholic Medical Center Seoul St. Mary's HospitalSae Woong Kim, M.D., Ph.D., Principal investigator, Catholic Medical Center Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02571101
- Sponsor's protocol ID
- CTC-PED-CDFR0812_P2
- Status last verified
- Dec 2015
- First submitted
- 6 Oct 2015
- Last updated
- 17 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-blinded, Active-control, 3-Treatment Arm, Parallel, Multi-center, Phase 2 Trial to Evaluate Safety and Efficacy With CDFR0812-15/25mg and CDFR0812-15/50mg Compared to Clomipramine HCl 15mg in Male Patients Diagnosed With Premature Ejaculation
- ClinicalTrials.gov ID
- NCT02571101
- Acronym / sponsor ID
- CTC-PED-CDFR0812_P2
- Conditions
- Premature Ejaculation
- Keywords
- Clomipramine, Premature ejaculation, CDFR0812, Sildenafil
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 297 participants (estimated)
- Lead sponsor
- CTC Bio, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Symyoo
- Study start
- Nov 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 8 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test 1 | Experimental | Drug: CDFR0812-15/25mg, Drug: Condencia-PlaceboTest 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. |
| Test 2 | Experimental | Drug: CDFR0812-15/50mg, Drug: Condencia-PlaceboTest 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. |
| Comparator | Placebo comparator | Drug: Condencia, Drug: CDFR0812-PlaceboComparator subjects will take one tablet of Condencia and another tablet of CDFR0812-Placebo before sexual intercourse in on-demand for 8 weeks. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CDFR0812-15/25mgContains chlomipramine HCl 15mg and sildenafil citrate 25mg. | Drug | Test 1 |
| CDFR0812-15/50mgContains chlomipramine HCl 15mg and sildenafil citrate 50mg. | Drug | Test 2 |
| CondenciaContains chlomipramine HCl 15mg. | Drug | Comparator |
| CDFR0812-PlaceboPlacebo tablet of CDFR0812. | Drug | Comparator |
| Condencia-PlaceboPlacebo tablet of Condencia | Drug | Test 1, Test 2 |
Primary outcome
The fold change of IELT
Time frame: From 4 weeks to 8 weeks after dosing
IELT(Intravaginal Ejaculation Latency Time), which is to be reported through patient diary
6 secondary outcomes
The % change of IELT
Time frame: From 4 weeks to 8 weeks after dosing
The mean change of IELT
Time frame: From 4 weeks to 8 weeks after dosing
The response rate
Time frame: At 8 weeks after dosing
Global impression reported by patient
Time frame: At 8 weeks after dosing
Administration time of study drug
Time frame: for 8 weeks
Number of patients with adverse events
Time frame: for 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CDFR0812-15/25mg, CDFR0812-15/50mg and Condencia in people with Premature Ejaculation, run by CTC Bio, Inc. at 9 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Youngrang Lee (82-(0)70-4335-4759, yrlee@symyoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The fold change of IELT (time frame: From 4 weeks to 8 weeks after dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2015.