Clinical trial NCT01063881: The Asia-Pacific Flexible Dose Study of Dapoxetine and Patient Satisfaction in Premature Ejaculation Therapy
Official title: The Asia-Pacific Flexible Dose Study of Dapoxetine and Patient Satisfaction in Premature Ejaculation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sexual Dysfunction, Physiological
Keywords: Sexual Dysfunction, physiological
R096769
Dapoxetine
Phase 3b
Premature Ejaculation
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2010-02-05
Enrollment: 285
Sex: MALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to measure the efficacy of flexible dosing of dapoxetine in a setting similar to routine clinical practice.

Detailed description: This is a prospective, interventional study to evaluate efficacy and safety of flexible dose dapoxetine as Premature Ejaculation (PE) Therapy. The total study duration will be 16 weeks, composed of a 2-week pretreatment phase and a 12-week open-label treatment phase, followed by a telephone contact two weeks after Week 12 to follow-up adverse events. At Visit 1 (Screening) standardized assessment tool or patient questionnaires will be used to determine which of those patients with erectile dysfunction/premature ejaculation are eligible to participate in this study. Once enrolled the patient and his partner are expected to attempt sexual intercourse a minimum of 2 times (at least 24 hours apart) and to complete a Baseline Event Log. Starting at Visit 2 (Baseline), the patient (and partner) will complete the Premature Ejaculation Profile (PEP) at the beginning of every treatment visit for the duration of the study. Patients will be started on study drug instructed to take 1 tablet of dapoxetine 30 mg, as needed, 1 to 3 hours prior to sexual activity. The need for adjustments in the dose of dapoxetine, as well as to assess the occurrence of adverse events and concomitant therapy use will be assessed approximately every 4 weeks. Patients will complete Treatment Event Logs during each dosing throughout the open-label treatment phase. Patients who have their dose increased to 60 mg, will be scheduled for a telephone consultation 1 week after to determine how the dose change is tolerated. At Visit 5 (Final Visit/Week 12/Early Termination), the patients and partners will complete several standardized assessment questionnaires have all final visit procedures performed and schedule a telephone follow up contact to evaluate any adverse events. The starting dose of dapoxetine is 30 mg (one 30-mg tablet), taken approximately 1 to 3 hours prior to sexual activity. The dose may be increased after 4 weeks to 60 mg taken. The maximum recommended dosing frequency is once every 24 hours.

Eligibility criteria: Inclusion Criteria:

* Participants must be heterosexual males and in a stable monogamous, sexual relationship with a female partner for at least 6 months
* must score =11 in the Premature Ejaculation Diagnostic Tool (PEDT)
* Must have a self-estimated intravaginal ejaculatory latency time (IELT) of = 2 minutes
* Must have an International Index of Erectile Dysfunction (IIEF) score a total of \> or = to 21 in 6 questions from the IIEF used to assess for the absence of moderate to severe erectile dysfunction (ED)
* Premature ejaculation is not exclusively due to the direct effects of a substance (e.g., withdrawal from opioids)
* Must be in good general health with no clinically significant abnormalities as determined by medical history, physical examination, and clinical lab results
* Must have a blood pressure =180 mmHg systolic and =100 mmHg diastolic at screening and at the baseline visit
* Patient's partner must not be pregnant at screening as pregnancy might affect sexual activity
* Participants and partners must agree to attempt sexual intercourse at least 2 times (with a minimum of 24 hours between each event) during the 2-week baseline period and at least 4 times per month during the remainder of the study.

Exclusion Criteria:

* History of or current major psychiatric disorder such as mood disorder, anxiety disorder, schizophrenia, mania, suicidal ideation, other psychotic disorder
* History of alcohol abuse and dependence, non-alcohol psychoactive substance use disorder (except for caffeine or nicotine/tobacco)
* Suspected history of illicit or recreational drug use
* Known history of moderate to severe renal impairment

Primary outcomes:
measure: The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least "Slightly Better" in Response to Dapoxetine Treatment
timeFrame: Week 12
Secondary outcomes:
measure: The Patient's Level of Control Over Ejaculation
timeFrame: Baseline and Week 12
measure: The Patient's Level of Satisfaction With Intercourse
timeFrame: Baseline and Week 12
measure: The Patient's Level of Personal Distress Related to the Speed of Ejaculation
timeFrame: Baseline and Week 12
measure: The Patient's Degree of Interpersonal Difficulty Related to the Speed of Ejaculation
timeFrame: Baseline and Week 12
measure: Patient Responses to Improvement With Their Premature Ejaculation After 12 Weeks of Treatment With Dapoxetine
timeFrame: Week 12
measure: The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least "Slightly Better" in Response to Dapoxetine Treatment (Subgroups by Dosage)
timeFrame: Week 12
measure: The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least "Slightly Better" in Response to Dapoxetine Treatment (Subgroups by Disease Type)
timeFrame: Week 12
measure: The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least "Slightly Better" in Response to Dapoxetine Treatment (Subgroups by Intravaginal Ejaculation Latency Time [IELT])
timeFrame: Week 12
Other outcomes:
Locations:
city: Malvern
country: Australia
city: St Leonards
country: Australia
city: Sydney
country: Australia
city: Busan
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Gwangju-Si
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
city: Jeonju-Si
country: Korea, Republic of
city: Jinju-Si
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Wonju
country: Korea, Republic of
city: Bangkok
country: Thailand
city: Chiang Mai
country: Thailand
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: