NCT07426640

Brief Summary

Premature ejaculation is a common sexual condition that can cause distress for men and their partners. Different treatments are available, but some men do not respond well to standard therapies. This study was designed to evaluate whether injecting botulinum toxin type A into two areas of the penis and surrounding muscles can help delay ejaculation in men with lifelong premature ejaculation. Participants were randomly assigned to receive either botulinum toxin injections or placebo injections. The study evaluated ejaculation time, sexual satisfaction, and quality of life over a follow-up period of six months. Safety and possible side effects were also monitored during the study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2026

Completed
Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

3.1 years

First QC Date

February 17, 2026

Last Update Submit

March 15, 2026

Conditions

Premature (Early) Ejaculation

Keywords

premature ejaculationBotulinum toxin type Aintravaginal Ejaculatory Latency TIMESexual Dysfunction

Outcome Measures

Primary Outcomes (2)

  • intravaginal ejaculatory latency time (IELT )

    intravaginal ejaculatory latency time was defined as the time from vaginal penetrationto ejaculation . measured by stopwatch in minutes or seconds

    Baseline to 6 months after intervention

  • Intravaginal Ejaculatory Latency Time ( IELT)

    (IELT) was defined as the time from vaginal penetration to ejaculation, measured in minutes using a stopwatch

    Baseline to 6 months after intervention

Secondary Outcomes (1)

  • sexual satisfaction

    Baseline to 6 months after intervention

Study Arms (2)

BOTULINUM TOXIN TYPE A

EXPERIMENTAL

Botulinum toxin type A was injected into the bulbospongiosus muscle and glans penis according to a standerdized protocol. this intervention was designed to modulate neuromuscular activity involved in the ejaculatory reflex

Drug: BoNT-A

placebo

PLACEBO COMPARATOR

placebo injection were administered into the bulbospongiosus muscle and the glans penis using the same procedure and volume as the experimental intervention

Drug: Placebo injection (normal saline)

Interventions

BoNT-ADRUG

participants were randomly assigned to one of two parallel groups to receive either Botulinum toxin type A injection or placebo injections( normal saline ) and were followed prospectively also the dual site injection is new

BOTULINUM TOXIN TYPE A
Placebo injection (normal saline)DRUG

injection of equivalent amount of normal saline by same technique and mechanism into the bulbospongiosus muscle and the glans penis

Also known as: sodium chloride
placebo

Eligibility Criteria

Age20 Years - 50 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsEligibility for this study was based on biological sex characteristics relevant to the study condition.participants were required to have male reproductive anatomy necessary for assessment of premature ejaculation
Healthy VolunteersNo
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Urology Al Mouwasat Hospital Riyadh

Riyadh, Riyadh Region, 11536, Saudi Arabia

Location

Related Publications (3)

  • Althof SE, Abdo CH, Dean J, Hackett G, McCabe M, McMahon CG, Rosen RC, Sadovsky R, Waldinger M, Becher E, Broderick GA, Buvat J, Goldstein I, El-Meliegy AI, Giuliano F, Hellstrom WJ, Incrocci L, Jannini EA, Park K, Parish S, Porst H, Rowland D, Segraves R, Sharlip I, Simonelli C, Tan HM; International Society for Sexual Medicine. International Society for Sexual Medicine's guidelines for the diagnosis and treatment of premature ejaculation. J Sex Med. 2010 Sep;7(9):2947-69. doi: 10.1111/j.1743-6109.2010.01975.x.

    PMID: 21050394RESULT

  • Waldinger MD. Premature ejaculation: definition and drug treatment. Drugs. 2007;67(4):547-68. doi: 10.2165/00003495-200767040-00005.

    PMID: 17352514RESULT

  • McMahon CG, Althof S, Waldinger MD, Porst H, Dean J, Sharlip I, Adaikan PG, Becher E, Broderick GA, Buvat J, Dabees K, Giraldi A, Giuliano F, Hellstrom WJ, Incrocci L, Laan E, Meuleman E, Perelman MA, Rosen R, Rowland D, Segraves R; International Society for Sexual Medicine Ad Hoc Committee for Definition of Premature Ejaculation. An evidence-based definition of lifelong premature ejaculation: report of the International Society for Sexual Medicine Ad Hoc Committee for the Definition of Premature Ejaculation. BJU Int. 2008 Aug;102(3):338-50. doi: 10.1111/j.1464-410X.2008.07755.x. Epub 2008 May 21.

    PMID: 18498422RESULT

MeSH Terms

Conditions

Premature BirthPremature EjaculationSexual Dysfunction, Physiological

Interventions

incobotulinumtoxinASaline SolutionSodium Chloride

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesEjaculatory DysfunctionGenital Diseases, MaleGenital DiseasesMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Haitham Abdalla Shello, MD

    AL MOUWASAT HOSPITAL ,RIYADH SAUDI ARABIA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
participants ,care providers ,investigators ,and outcome assessors were blinded to treatment assignment
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: participants were randomly assigned to one of two parallel groups to receive either botulinum toxin type A injection or placebo injections and were followed prospectively
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD Urology and Andrology

Study Record Dates

First Submitted

February 17, 2026

First Posted

February 23, 2026

Study Start

November 1, 2021

Primary Completion

November 30, 2024

Study Completion

November 30, 2024

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

De-identified individual participant data underlying the results reported in the article,along with the study protocol and statistical analysis plan,will be made available upon reasonable request to the corresponding author following publication

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
beginning 3 months following publication and ending 5 years after publication
Access Criteria
data will be available to researchers who provide a methodologically sound proposals and will be reviewed by the corresponding author. Data will be shared after de-identification
More information

Locations

SA(1)