Status unknownNCT05749614Updated Mar 1, 2023

Precise Use of Lidocaine Cream to Treat Primary Premature Ejaculation

An interventional study of Lidocaine cream and Lidocaine cream in Premature Ejaculation, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Status unknown at 1 site in China. Open to male participants aged 19 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-03-01.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

Registered 11 months after the study started (first participant enrolled Mar 2022, registered Feb 2023).

Phase: Not applicable
Study type: Interventional
Enrollment: 80
Allocation: Non-randomized
Ages: 19 Years to 60 Years
Sex: Male

Study summary

This study aimed to evaluate the efficacy and safety of applying 5% lidocaine cream to the sensitive area of the glans penis after its precise localization under the penile biological vibration threshold test for the treatment of primary premature ejaculation.

Read the detailed description

This study was a randomized, single-blind clinical controlled trial. Eighty patients diagnosed with primary premature ejaculation in an outpatient setting were included in this study. They were randomly scored into two groups. Group 1 (n = 40) was given 1 ml of 5% lidocaine cream on demand. They were instructed to apply the lidocaine cream evenly in a circular pattern to the glans penis without precise application to the sensitive area of the glans penis. The treatment lasted for a total of 4 weeks. Group 2 (n = 40) had a penile biological vibration threshold test performed to detect loci with a lower threshold. They were instructed to apply 1 ml of 5% lidocaine cream to the sensitive loci on the glans penis for 4 weeks. Lidocaine cream was applied topically or uniformly to the glans penis 20 minutes before planned intercourse in both groups and washed off 10 minutes after application. Using intravaginal ejaculation before and after treatment latency, the Arabic Index of Premature Ejaculation, Premature Ejaculation Diagnostic Tool, and the International Index of Erectile Function Scale scores were combined to assess the efficacy and side effects before and after treatment.

Conditions studied

Premature Ejaculation

Browse trials for

Premature Ejaculation 106

Keywords

Primary premature ejaculation; Lidocaine; Arabic Index of Premature Ejaculation

In context

Premature Ejaculation

106 studies on the registry are indexed under Premature Ejaculation; 17 are open to participants now.

This study's planned enrollment of 80 is close to the median of 84 across 89 interventional studies indexed under Premature Ejaculation.

Browse Premature Ejaculation studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,047 studies on the registry; 502 are open to participants now.

Browse Second Affiliated Hospital, School of Medicine, Zhejiang University studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 19 Years to 60 Years
Sexes eligible: Male
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

adult male (19-60 years old); stable partner for ≥3 months; Premature Ejaculation Diagnostic Tool (PEDT) score ≥ 11; penile biological vibration threshold test suggesting the presence of sensitive sites on the glans penis (vibration threshold \< 30 levels); no history of long-term use of specific medications; normal sex hormone levels; and no genital or secondary ejaculation. There was no history of long-term use of specific drugs, normal sex hormone levels, and genital or secondary sexual characteristics abnormalities.

Exclusion criteria

Exclusion Criteria:

(1) those with abnormal or malformed genital development; (2) those with allergic reactions to local anesthetics; (3) those who had been treated with central nervous system drugs or PE in the last 3 months; (4) those with a history of long-term alcohol abuse and trauma such as neurological and pelvic fractures; (5) those with long-term use of hypotensive drugs, diuretics, and sedative drugs (6) patients with a history of previous surgery and trauma to the reproductive system; (7) patients with PE due to hypogonadism, thyroid disease, and abnormal lipid metabolism.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 80 participants (estimated)

Study arms

Experimental
Group 1
Drug: Lidocaine cream
Experimental
Group 2
Drug: Lidocaine cream

Interventions

DrugLidocaine cream
Group 1 was given 1 ml of 5% lidocaine cream on demand. They were instructed to apply the lidocaine cream evenly in a circular pattern to the glans penis without precise application to the sensitive area of the glans penis. The treatment lasted for a total of 4 weeks.
DrugLidocaine cream
Group 2 had a penile biological vibration threshold test performed to detect loci with a lower threshold. They were instructed to apply 1 ml of 5% lidocaine cream to the sensitive loci on the glans penis for 4 weeks.

What researchers measure

Primary outcomes

Arabic Index of Premature Ejaculation (AIPE)
Time frame: through study completion,an average of 4 weeks

Study locations

1 of 1 sites recruiting

Luopei Wei
Hangzhou, Zhejiang, China
Recruiting
- Chen Zexin · Contact · keyanlunli_zheer@163.com · +86 0571 87783759
Recruiting

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2022 (actual). Primary completion is estimated for Mar 2023, 12 months after the start.

Of 25 interventional studies with no phase under Premature Ejaculation, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 39. This study's planned 12 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered: Feb 19, 2023
First posted: Mar 1, 2023
StartActual: Mar 1, 2022
Primary completionEst.: Mar 1, 2023
CompletionEst.: Apr 1, 2023
Last update: Mar 1, 2023

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Mar 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05749614
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible party: Sponsor
First posted: Mar 1, 2023
Start date: Mar 1, 2022
Primary completion: Mar 1, 2023 (estimated)
Completion: Apr 1, 2023 (estimated)
Last update: Mar 1, 2023

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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