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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 Ejaculation

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 Ejaculation

Status
Unknown
Phases
Early Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20240601001
Enrollment
118
Registered
2024-06-01
Start date
2023-10-07
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction Premature Ejaculation Tadalafil Lidocaine Erectile Dysfunction Premature Ejaculation Randomized Controlled Trial Sexual Function Clinical Study

Interventions

Participants take 20mg Tadalafil weekly for 12 weeks.,Participants take 20mg Tadalafil and use Lidocaine spray weekly for 12 weeks.
Active Comparator Drug,Experimental Drug
Tadalafil,Tadalafil and Lidocaine Spray

Sponsors

The First Affiliated Hospital of Gannan Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 60 Years

Inclusion criteria

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

Exclusion criteria: Heart failure Chronic prostatitis/prostatodynia Paraplegia Depression

Design outcomes

Primary

MeasureTime frame
International Index of Erectile Function-5 12 weeks International Index of Erectile Function Questionnaire,Sexual Satisfaction Score (SSS) 12 weeks Sexual Satisfaction Questionnaire

Secondary

MeasureTime frame
Intravaginal Ejaculatory Latency Time 12 weeks Intra-Vaginal Ejaculation Latency Time

Countries

China

Contacts

Public ContactMin Liu

Gannan Medical University

13879787985@163.com138 7978 7985

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026