A Placebo-Controlled, Double-Blind, Randomized, Parallel-Group Study of the Efficacy and Safety of Dapoxetine in the Treatment of Subjects With Premature Ejaculation - Study of Dapoxetine in the Treatment of Subjects With Premature Ejaculatio
- Conditions
- Premature Ejaculation (PE)
- Registration Number
- EUCTR2004-002700-16-DE
- Lead Sponsor
- Janssen-Cilag International N.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 1300
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 moderately 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 <= 2 minutes in a minimum of 3 out of 4 evaluable events (if more than 4 evaluable events have been recorded in the Baseline Event Log, a minimum of 75% of evaluable events must have an IELT <= 2 minutes)
- an evaluable event is one for which the subject or his partner has indicated prior to vaginal penetration or intravaginal under the Ejaculation Occurred field on the Baseline Event Log and for which at least 20 hours have passed since the subject's last ejaculation
Must be in good general health before study participation with no clinically relevant abnormalities as determined by: medical history, physical examination, blood chemistry, complete blood count, urinalysis, and 12-lead ECG
Subject's and partners are willing to follow the recommendation to avoid situations/activities that may have an affect on their sexual activity (e.g., avoid pregnancy, refrain from any preplanned surgery)
Subject's partner must have a negative urine pregnancy test at screening as pregnancy might affect sexual activity
Subjects and partners must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate
Subjects must have signed the informed consent for genetic testing indicating whether they do or do not wish to participate in the genetic part of the study; participation in the genetic testing component is not mandatory for participation in the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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 (including cardiac synkope), pulmonary, gastrointestinal, hematologic, neurologic (including seizure disorders), locomotor, immunologic, ophthalmologic, metabolic, endocrine, thromboembolic (including history of pulmonary embolism), rheumatologic, oncologic, renal, or hepatic disorders. Subjects with a history of hypertension (inlcuding newly diagnosed hypertension) must be adequately treated on a stable antihypertensive medical regimen for at least 4 weeks before screening.
Subjects with either a blood pressure of >= 180mmHg systolic or >= 100mmHG diastolic both at screening (Visit 1) and at the end of the baseline period (Visit 2), or a pulse rate of >= 100 beats per minute at Visits 1 and 2 should be excluded form enrollment.
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 or 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method