Premature Ejaculation (PE)
Conditions
Interventions
Product Name: dapoxetine
Pharmaceutical Form: Tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Tablet
Route of adminis
Sponsors
Janssen-Cilag International N.V.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Males 18 years and older, in a stable, monogamous, sexual relationship with the same woman for at least 6 months and plans to maintain this relationship for the duration of the study. Subjects must, by reported history, meet the following diagnostic criteria for PE as specified in the DSM-IV-TR for at least 6 months before enrolling in the study, specifically: - the onset of orgasm and ejaculation occurs with minimal sexual stimulation before, on, or shortly after penetration and before the person wishes it - PE in the majority of intercourse experiences - PE must cause at least distress or interpersonal difficulty, as defined by a subject's response to "Personal Distress" and "Relationship Distress" questions in the Ejaculation Questionnaire. To be eligible to participate in the study a subject must define distress level as at least "a little bit distressed" for at least 1 of these questions - PE must not be exclusively due to the direct effects of a substance (e.g., withdrawal from opioids) Has a qualifying IELT according to the Baseline Event Log (reviewed at baseline before the first dose of study drug), which is defined as follows: - an IELT of =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Has received study drug in prior dapoxetine trials or has participated in another study within the past 3 months investigating pharmacologic treatment of PE Significant history of or current cardiovascular, pulmonary, gastrointestinal, hematologic, neurologic (including seizure disorders), locomotor, immunologic, ophthalmologic, metabolic, endocrine, thromboembolic (including history of pulmonary embolism), rheumatologic, oncologic, renal, or hepatic disorders Has a history of any medical events such as surgical interventions (e.g., pelvic/retroperitoneal surgery), neurological conditions (e.g., multiple sclerosis), trauma (e.g., spinal cord injury), or infections (e.g., chronic prostatitis) that were associated with the onset of PE symptoms and considered a potential cause of PE Has taken an investigational drug within 1 month of the screening visit or within a period of less than 5 times the drugs half-life, whichever is longer or used an experimental medical device within 6 months of the screening visit Has taken disallowed medication and has not completed the required washout period (Attachment 1, Washout Requirements for Selected Medications/Treatments) Positive diagnosis of depressive or anxiety disorder, dysthymia, suicidality, (hypo) manic episode, panic disorder, agoraphobia, social phobia, obsessive-compulsive disorder, posttraumatic stress disorder, alcohol abuse and dependence, non-alcohol psychoactive substance use disorder, or psychotic disorders based on the Mini International Neuropsychiatric Interview (M.I.N.I.) Has a history of drug abuse within the past 2 years Has a history of or current major psychiatric disorder such as mood disorders, anxiety disorders, schizophrenia, other psychotic disorders, or alcoholism. Subjects meeting DSM-IV-TR diagnosis for a current depressive or anxiety disorder, or subjects who received any treatment (pharmacotherapy and/or psychotherapy) for a depressive or anxiety disorder within the past 2 years, must also be excluded. (Subjects who report anxiety primarily centering on sexual performance/PE may be included) Has significant problems with other forms of sexual dysfunction, such as decreased interest in sexual intercourse inhibited or absent orgasm or ejaculation, and erectile dysfunction (ED) Currently receiving treatment for ED or has a score of <21 in the Erectile Function Domain of the International Index of Erectile Function Questionnaire (IIEF, Questions 1 through 5 and 15) History of human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C Subjects with hyperprolactinemia and untreated or insufficiently treated hypothyroidism Has a known allergy or hypersensitivity to SSRIs or serotonin norepinephrine reuptake inhibitors (SNRIs) Any significant condition that, in the opinion of the investigator, could interfere with the subject's or their partner's participation or compliance in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that dapoxetine (30 or 60 mg prn) can prolong intravaginal ejaculatory latency time (IELT) as measured by stopwatch when compared to placebo in men with PE during the 24-week treatment phase;Secondary Objective: To assess patient-reported outcomes in subjects receiving dapoxetine compared to those in subjects receiving placebo;Primary end point(s): Average IELT at the end of the double-blind treatment phase | — |
Countries
Czech Republic, Finland, Germany, Hungary, Italy, Spain, Sweden, United Kingdom
Outcome results
None listed