The effect of different doses of paroxetine in premature ejaculation: a prospective randomized cross-over clinical trial

UMIN ID: UMIN000054623

Registered date:11/06/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: male sexual dysfunction
• Date of first enrollment: 2024/07/16
• Target sample size: 140
• Countries of recruitment: Africa
• Study type: Interventional

Intervention(s)

group 1 will receive 12.5 mg paroxetine daily for 2 months then gradual tapering for 2 weeks then a 2 week washout period
group 2 will receive 20 mg paroxetine daily for 2 months then gradual tapering for 2 weeks then a 2 week washout period

Outcome(s)

• Primary Outcome: evaluating the effect of different doses of Paroxetine in premature ejaculation
• Secondary Outcome: safety profile and complications of different doses of Paroxetine in premature ejaculation

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 45years-old
• Gender: Male
• Exclude criteria: Patients with erectile dysfunction (men having International Index of Erectile Function (IIEF) score (validated Arabic version) <21), reduced sexual desire or inhibited male orgasm were excluded from the study. In addition, patients with presence of mental disorders, physical illnesses affecting ejaculatory function, abuse of alcohol or recreational drugs and any psychotropic medications that may affect response to SSRIs or any medical treatment for premature ejaculation in the past 6 months were also excluded. Also, patients with urinary tract infection will be excluded.

Related Information

• Primary Sponsor: Kasr alainy cairo university
• Source(s) of Monetary Support: Kasr alainy cairo university
• Secondary ID(s): sameh fayek gamalel din