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

NCT ID: NCT04361305

Last Updated: 2020-04-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-03
• Study Completion Date: 2021-04-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

tadalafil combined with dapoxetine

Group Type: EXPERIMENTAL

Dapoxetine

Intervention Type: 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

Intervention Type: DRUG

5 mg tablets every day for 8 weeks

tadalafil mono group

Group Type: ACTIVE_COMPARATOR

Tadalafil

Intervention Type: DRUG

5 mg tablets every day for 8 weeks

Interventions

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

Intervention Type: DRUG

Tadalafil

5 mg tablets every day for 8 weeks

Intervention Type: DRUG

Tadalafil

5 mg tablets every day for 8 weeks

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Yan-Ping Huang

OTHER

Sponsor Role: lead

Responsible Party

Yan-Ping Huang

Department of Urology and Andrology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

0412

Identifier Type: -

Identifier Source: org_study_id