Assessment of the Efficacy and Safety of On-Demand Use of Tadalafil Alone versus Combination with Lidocaine Spray for the Treatment of Patients with Erectile Dysfunction and Premature Ejaculatio

Phase 1

Recruiting

• Conditions: Erectile DysfunctionPremature Ejaculation; Tadalafil; Lidocaine; Erectile Dysfunction; Premature Ejaculation; Randomized Controlled Trial; Sexual Function; Clinical Study

• Registration Number: TCTR20240601001
• Lead Sponsor: The First Affiliated Hospital of Gannan Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2024-05-28
• Study Start: 2024-06-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 118

Inclusion Criteria

Couples who have had regular sexual activity within the past six months.
Patients with a detailed medical history (including sexual history) and a comprehensive physical examination.
Eligible patients underwent a four-week screening diagnostic period, recording the number of sexual activities, intra-vaginal ejaculation latency period, sexual performance, and satisfaction, etc.
Exclusions were made for heart failure, chronic prostatitis/chronic pelvic pain syndrome, paraplegia, depression, etc.

Exclusion Criteria

Heart failure
Chronic prostatitis/prostatodynia
Paraplegia
Depression

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
International Index of Erectile Function-5 12 weeks International Index of Erectile Function Questionnaire,Sexual Satisfaction Score (SSS) 12 weeks Sexual Satisfaction Questionnaire

Secondary Outcome Measures

Name	Time	Method
Intravaginal Ejaculatory Latency Time 12 weeks Intra-Vaginal Ejaculation Latency Time