Premature EjaculationPhase 3NCT04361305
Observational Study of Pharmacological Treatment for Premature Ejaculation Concurrent With Erectile Dysfunction
A Phase 3 study testing Dapoxetine and Tadalafil in people with Premature Ejaculation and Erectile Dysfunction, run by Yan-Ping Huang.
Trial summary
Premature ejaculation (PE) is a common disease in the andrology clinic. Currently, the effectiveness and outcome differences of drug treatment still need to be studied and demonstrated. Premature ejaculation concurrent with erectile dysfunction (ED) is common in outpatient clinics. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Premature Ejaculation, Erectile Dysfunction
- What is being tested?
- Dapoxetine and Tadalafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 3 Jun 2020to 1 Apr 2021
- Phase
- Phase 3
- 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 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- PE concurrent with ED: the IELT is less than 3 minutes, the PEDT score is ≥11 points, and 5≤IIEF-5≤21 points.
- 18-60 years old, outpatient or physical examination population, with regular sex partners and regular sex life;
- Having the data below,and willing to participate in the trial（1）Demographic information: age, gender, nationality, birthplace, etc;(2) Physical examination data: height, weight, abdominal circumference, blood pressure, heart rate, etc ;(3) Medical history data: history of present illness, past medical history, family history, etc;(4) Scale evaluation: Premature Ejaculation Diagnostic Tool (PEDT), Premature Ejaculation Profile (PEP), International Erectile Function Score-5(IIEF-5), Erectile Hardness Grading Score (EHGS), Clinical Global Impression of Change (GICC);
Who cannot join
- Age <18 years or> 60 years;
- There is a history of acute and chronic diseases, major trauma and surgery, etc;
- A long history of medication;
- There is a history of unstable myocardial infarction and cerebral infarction;
- A history of cardiogenic shock, severe heart failure, severe ventricular arrhythmia, etc;
- There are serious diseases such as malignant tumors, chronic liver and kidney diseases, etc.
About this study
Official title: Multicenter Study of the Efficacy and Safety of Dapoxetine Combined With Tadalafil in Men With Premature Ejaculation and Concomitant Erectile Dysfunction
Premature ejaculation (PE) is a common disease in the andrology clinic. Currently, the effectiveness and outcome differences of drug treatment still need to be studied and demonstrated. Premature ejaculation concurrent with erectile dysfunction (ED) is common in outpatient clinics. The preferred treatment plan for these patients still needs to be further studied and explored, and the difference in the efficacy of different treatment regiments remain to be evaluated.
- Conditions
- Premature Ejaculation, Erectile Dysfunction
- Being tested
- Dapoxetine, Tadalafil
- Medical subject headings
- Premature Ejaculation, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapoxetineDrug
30 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 8 weeks Tadalafil 5 mg tablets every day for 8 weeks
TadalafilDrug
5 mg tablets every day for 8 weeks
TadalafilDrug
5 mg tablets every day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| tadalafil combined with dapoxetine | Experimental | Not described Receives: Drug: Dapoxetine; Drug: Tadalafil |
| tadalafil mono group | Active comparator | Not described Receives: Drug: Tadalafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of Premature Ejaculation Profile (PEP) at week 8
The PEP is a 4-question PRO that asks a respondent about his subjective sense of control over ejaculation, distress related to PE, interpersonal difficulty and satisfaction with sexual intercourse.
Measured: Baseline, Week 8
The change of International Index of Erectile Function -5(IIEF-5) at week 8
Measured: Baseline, Week 8
Secondary outcomes (3)
Incidence of adverse reactions
To observe the safety of the two regiments in PE concurrent with ED patients
Measured: Baseline, Week 8
The change of Erection Hardness Score (EHS)
Erection Hardness Score as a self-reporting measure that scored erection hardness on a 4 point scale. The aim was to help men, their partners and doctors diagnose erectile dysfunction.
Measured: Baseline, Week 8
Clinical Global Impression of Change (GICC)
Clinical Global Impression is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.
Measured: Baseline, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start3 Jun 2020 (estimated)
- Primary completion11 Jan 2021 (estimated)
- Study completion1 Apr 2021 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yan-Ping Huang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yan-Ping Huang, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04361305
- Sponsor's protocol ID
- 0412
- Status last verified
- Apr 2020
- First submitted
- 22 Apr 2020
- Last updated
- 24 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study of the Efficacy and Safety of Dapoxetine Combined With Tadalafil in Men With Premature Ejaculation and Concomitant Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT04361305
- Acronym / sponsor ID
- 0412
- Conditions
- Premature Ejaculation, Erectile Dysfunction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Yan-Ping HuangUniversity, hospital or other
- Study start
- 3 Jun 2020 (estimated)
- Primary completion
- 11 Jan 2021 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 24 Apr 2020 (actual)
- 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.
Premature ejaculation (PE) is a common disease in the andrology clinic. Currently, the effectiveness and outcome differences of drug treatment still need to be studied and demonstrated. Premature ejaculation concurrent with erectile dysfunction (ED) is common in outpatient clinics. The preferred treatment plan for these patients still needs to be further studied and explored, and the difference in the efficacy of different treatment regiments remain to be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tadalafil combined with dapoxetine | Experimental | Drug: Dapoxetine, Drug: Tadalafil |
| tadalafil mono group | Active comparator | Drug: Tadalafil |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- PE concurrent with ED: the IELT is less than 3 minutes, the PEDT score is ≥11 points, and 5≤IIEF-5≤21 points.
- 18-60 years old, outpatient or physical examination population, with regular sex partners and regular sex life;
- Having the data below,and willing to participate in the trial（1）Demographic information: age, gender, nationality, birthplace, etc;(2) Physical examination data: height, weight, abdominal circumference, blood pressure, heart rate, etc ;(3) Medical history data: history of present illness, past medical history, family history, etc;(4) Scale evaluation: Premature Ejaculation Diagnostic Tool (PEDT), Premature Ejaculation Profile (PEP), International Erectile Function Score-5(IIEF-5), Erectile Hardness Grading Score (EHGS), Clinical Global Impression of Change (GICC);
Key exclusion criteria (6 listed)
- Age <18 years or> 60 years;
- There is a history of acute and chronic diseases, major trauma and surgery, etc;
- A long history of medication;
- There is a history of unstable myocardial infarction and cerebral infarction;
- A history of cardiogenic shock, severe heart failure, severe ventricular arrhythmia, etc;
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 |
|---|---|---|
| Dapoxetine30 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 8 weeks Tadalafil 5 mg tablets every day for 8 weeks | Drug | tadalafil combined with dapoxetine |
| Tadalafil5 mg tablets every day for 8 weeks | Drug | tadalafil mono group |
| Tadalafil5 mg tablets every day for 8 weeks | Drug | tadalafil combined with dapoxetine |
Primary outcome
The change of Premature Ejaculation Profile (PEP) at week 8
Time frame: Baseline, Week 8
The PEP is a 4-question PRO that asks a respondent about his subjective sense of control over ejaculation, distress related to PE, interpersonal difficulty and satisfaction with sexual intercourse.
The change of International Index of Erectile Function -5(IIEF-5) at week 8
Time frame: Baseline, Week 8
3 secondary outcomes
Incidence of adverse reactions
Time frame: Baseline, Week 8
The change of Erection Hardness Score (EHS)
Time frame: Baseline, Week 8
Clinical Global Impression of Change (GICC)
Time frame: Baseline, Week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dapoxetine and Tadalafil in people with Premature Ejaculation and Erectile Dysfunction, run by Yan-Ping Huang.
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 3 inclusion and 6 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 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of Premature Ejaculation Profile (PEP) at week 8 (time frame: Baseline, Week 8). The study lists 2 primary outcomes in all. 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 24 Apr 2020.