Observational Study of Pharmacological Treatment for Premature Ejaculation Concurrent With Erectile Dysfunction

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.

Study Overview

• Status: Unknown
• Conditions: Erectile Dysfunction; Premature Ejaculation
• Intervention / Treatment: Drug: Dapoxetine; Drug: Tadalafil

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. PE concurrent with ED: the IELT is less than 3 minutes, the PEDT score is ≥11 points, and 5≤IIEF-5≤21 points.
2. 18-60 years old, outpatient or physical examination population, with regular sex partners and regular sex life;
3. 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);

Exclusion Criteria:

1. Age <18 years or> 60 years;
2. There is a history of acute and chronic diseases, major trauma and surgery, etc;
3. A long history of medication;
4. There is a history of unstable myocardial infarction and cerebral infarction;
5. A history of cardiogenic shock, severe heart failure, severe ventricular arrhythmia, etc;
6. There are serious diseases such as malignant tumors, chronic liver and kidney diseases, etc.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tadalafil combined with dapoxetine	Drug: Dapoxetine; 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; Drug: Tadalafil; 5 mg tablets every day for 8 weeks
Active Comparator: tadalafil mono group	Drug: Tadalafil; 5 mg tablets every day for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 8
The change of International Index of Erectile Function -5(IIEF-5) at week 8		Baseline, Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse reactions	To observe the safety of the two regiments in PE concurrent with ED patients	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.	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.	Baseline, Week 8

Collaborators and Investigators

• Sponsor: Yan-Ping Huang

Study record dates

Study Major Dates

• Study Start (Anticipated): June 3, 2020
• Primary Completion (Anticipated): January 11, 2021
• Study Completion (Anticipated): April 1, 2021

Study Registration Dates

• First Submitted: April 22, 2020
• First Submitted That Met QC Criteria: April 23, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Actual): April 24, 2020
• Last Update Submitted That Met QC Criteria: April 23, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pregnancy Complications; Obstetric Labor Complications; Sexual Dysfunctions, Psychological; Obstetric Labor, Premature; Sexual Dysfunction, Physiological; Premature Birth; Erectile Dysfunction; Premature Ejaculation; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Tadalafil
• Other Study ID Numbers: 0412

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No