A Phase 3 interventional study of Dapoxetine and Tadalafil in Premature Ejaculation and Erectile Dysfunction, sponsored by Yan-Ping Huang. Status unknown. Open to male participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-04-24.
Sponsored by Yan-Ping Huang · Phase 3, Interventional, and Treatment
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.
106 studies on the registry are indexed under Premature Ejaculation; 17 are open to participants now.
This study's planned enrollment of 150 is above the median of 84 across 89 interventional studies indexed under Premature Ejaculation.
Browse Premature Ejaculation studies →This is the only study on the registry with Yan-Ping Huang as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Drug: Dapoxetine · Drug: Tadalafil
Drug: Tadalafil
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
5 mg tablets every day for 8 weeks
5 mg tablets every day for 8 weeks
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.
Time frame: Baseline, Week 8
The change of International Index of Erectile Function -5(IIEF-5) at week 8
Time frame: Baseline, Week 8
Incidence of adverse reactions
To observe the safety of the two regiments in PE concurrent with ED patients
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Week 8
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jun 2020; primary completion for Jan 2021, 7 months later.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Dapoxetine