Concomitant Use of PriLigy in Men Treated for Erectile Dysfunction
Condition: Erectile Dysfunction; Sexual Dysfunction
MeSH terms: Erectile Dysfunction; Premature Ejaculation
Intervention: Placebo; Dapoxetine; PDE5I (phosphodiesterase-5 inhibitor)
Intervention description: Tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks.; 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks.; Patients were to be using a stable regimen of a PDE5-I (i.e., sildenafil, vardenafil, or tadalafil), as reported by the patient for the treatment of erectile dysfunction (ED) for at least 3 months before screening and up to 12 weeks during treatment in the study.
Intervention MeSH terms: Phosphodiesterase 5 Inhibitors
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 495.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Erectile Dysfunction; Sexual Dysfunction; Dapoxetine hydrochloride; PRILIGY; Premature ejaculation; Serotonin Uptake Inhibitors; Sildenafil (Viagra); Vardenafil (Levitra); Tadalafil (Cialis)

Summary:

      The purpose of this study is to evaluate the efficacy and safety of dapoxetine compared to
      placebo in men with premature ejaculation and erectile dysfunction who are currently being
      treated with a phosphodiesterase-5 inhibitor (ie, sildenafil, vardenafil, or tadalafil) for
      erectile dysfunction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of erectile dysfunction (ED), International Index of Erectile
             Function (IIEF) score >=21 at screening and baseline, and receiving treatment with a
             stable regimen of a phosphodiesterase 5 (PDE 5) inhibitor (ie, sildenafil, vardenafil,
             or tadalafil) for the treatment of ED for at least 3 months before screening

          -  Study participant in a stable, monogamous sexual relationship with the same woman for
             at least 6 months before screening and plan to maintain this relationship for the
             duration of the study

          -  Study participant medically stable (ie, in good general health) on the basis of
             physical examination, medical history, vital signs, 12 lead ECG, and clinical
             laboratory tests performed at screening

        Exclusion Criteria:

          -  History suggestive of syncope (a condition characterized by a loss of consciousness)

          -  History of medical events such as surgical interventions or neurologic conditions (eg,
             multiple sclerosis), trauma, or infections that are associated with the development of
             symptoms of premature ejaculation (PE) and considered a potential cause of PE

          -  Current major psychiatric disorder such as mood disorder, anxiety disorder,
             schizophrenia, mania, suicidal ideation, other psychotic disorder, or alcoholism

          -  Known allergy, hypersensitivity, or intolerance to selective serotonin reuptake
             inhibitors (SSRIs) or selective noradrenaline reuptake inhibitors (SNRIs)

          -  Taken another investigational drug (or vaccine) within 30 days or used an
             investigational medical device within 6 months before screening, or enrolled in
             another investigational study