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

NCT04361305 | Unknown Phase 3

• 1 other identifier: 0412
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Incidence of adverse reactions

  Baseline, Week 8

• The change of Erection Hardness Score (EHS)

  Baseline, Week 8

• Clinical Global Impression of Change (GICC)

  Baseline, Week 8

Study Arms (2)

tadalafil combined with dapoxetine

EXPERIMENTAL

Drug: Dapoxetine; Drug: Tadalafil

tadalafil mono group

ACTIVE COMPARATOR

Drug: Tadalafil

Interventions

Dapoxetine DRUG

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

tadalafil combined with dapoxetine

Tadalafil DRUG

5 mg tablets every day for 8 weeks

tadalafil mono group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• PE concurrent with ED: the IELT is less than 3 minutes, the PEDT score is ≥11 points, and 5≤IIEF-5≤21 points.
• 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yan-Ping Huang: lead

MeSH Terms

Conditions

Premature Ejaculation; Erectile Dysfunction

Interventions

dapoxetine; Tadalafil

Condition Hierarchy (Ancestors)

Ejaculatory Dysfunction; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Urology and Andrology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: April 24, 2020
• Study Start: June 3, 2020
• Primary Completion: January 11, 2021
• Study Completion: April 1, 2021
• Last Updated: April 24, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share