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Study on the efficacy and safety of rTMS combined with dapoxetine hydrochloride in the treatment of premature ejaculation

Study on the efficacy and safety of rTMS combined with dapoxetine hydrochloride in the treatment of premature ejaculation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108011
Enrollment
Unknown
Registered
2025-08-22
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-08-25

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

Conditions

Primary premature ejaculation

Interventions

SSRIS drug intervention group:rTMS sham stimulation Dapoxetine hydrochloride treatment
rTMS low-frequency SSRIS drug intervention group:rTMS low-frequency stimulation of dapoxetine hydrochloride treatment
rTMS high-frequency SSRIS drug intervention group:rTMS high-frequency stimulation of dapoxetine hydrochloride treatment

Sponsors

The First Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: (1) Age 18-45 years old, male; (2) Meet the 2014 International Medical Association (ISSM) diagnostic criteria for primary premature ejaculation; (3) Adults who have a stable life with a sexual partner for at least 6 months, have sex at least 2 times a week, and remain stable during the study period; (4) Such situations occur in every sexual intercourse since the first sexual life; (5) No erectile dysfunction; (6) Premature ejaculation diagnostic scale score >= 9 points; (7) Have not received any other treatment for premature ejaculation in the past or present, or stop other treatments for at least 3 months; (8) Sign the informed consent form and receive monthly WeChat, telephone or outpatient follow-up and guidance.

Exclusion criteria

Exclusion criteria: (1) Secondary premature ejaculation, variable premature ejaculation, subjective premature ejaculation; (2) Patients with any history of serious medical diseases, mental illnesses, or neurological diseases; (3) Have a clear history of drug use or known diseases that can cause sexual dysfunction. (4) Left-handed patients (5) Use of serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants (TCAs), and phosphodiester-5 inhibitors (PDE5-Is) or other drugs that may interfere with dapoxetine;

Design outcomes

Primary

MeasureTime frame
Incubation period of vaginal ejaculation;Premature Ejaculation Diagnostic Scale score;

Secondary

MeasureTime frame
Erectile Function Assessment Questionnaire;Hamilton Depression Rating Scale;Hamilton Anxiety Scale;Pittsburgh Sleep Quality Assessment Scale;

Countries

China

Contacts

Public ContactXiansheng Zhang

The First Affiliated Hospital of Anhui Medical University

xiansheng-zhang@163.com+86 135 1497 1898

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026