Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01063881
Registration number
NCT01063881
Ethics application status
Date submitted
4/02/2010
Date registered
5/02/2010
Date last updated
4/02/2013
Titles & IDs
Public title
The Asia-Pacific Flexible Dose Study of Dapoxetine and Patient Satisfaction in Premature Ejaculation Therapy
Query!
Scientific title
The Asia-Pacific Flexible Dose Study of Dapoxetine and Patient Satisfaction in Premature Ejaculation Therapy
Query!
Secondary ID [1]
0
0
R096769PRE3009
Query!
Secondary ID [2]
0
0
CR016561
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Sexual Dysfunction, Physiological
0
0
Query!
Condition category
Condition code
Reproductive Health and Childbirth
0
0
0
0
Query!
Complications of newborn
Query!
Reproductive Health and Childbirth
0
0
0
0
Query!
Childbirth and postnatal care
Query!
Reproductive Health and Childbirth
0
0
0
0
Query!
Fetal medicine and complications of pregnancy
Query!
Renal and Urogenital
0
0
0
0
Query!
Other renal and urogenital disorders
Query!
Reproductive Health and Childbirth
0
0
0
0
Query!
Other reproductive health and childbirth disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Dapoxetine
Experimental: Dapoxetine - Starting dose is one 30-mg tablet taken approximately 1-3 hours prior to sexual activity may be increased after 4 weeks to 60mg taken for 12 weeks. The maximum recommended dosing frequency is once every 24 hours.
Treatment: Drugs: Dapoxetine
Starting dose is one 30-mg tablet taken approximately 1-3 hours prior to sexual activity, may be increased after 4 weeks to 60mg, taken for 12 weeks. The maximum recommended dosing frequency is once every 24 hours.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least "Slightly Better" in Response to Dapoxetine Treatment
Query!
Assessment method [1]
0
0
The "Clinical Global Impression of Change" (CGIC), a patient-reported scale was used to assess the patient's improvement with premature ejaculation (PE) since initiating treatment with dapoxetine. Patients were asked: "Compared to the start of the study, would you describe your premature ejaculation (PE) problem as: Much worse, Worse, Slightly worse, No change, Slightly better, Better, or Much better?" The number of patients who described improvement with their PE of at least "slightly better" after 12 weeks of treatment with dapoxetine are provided in the table below.
Query!
Timepoint [1]
0
0
Week 12
Query!
Secondary outcome [1]
0
0
The Patient's Level of Control Over Ejaculation
Query!
Assessment method [1]
0
0
The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of control over intercourse on a 5-point scale. Patients were asked: "Over the past month, was your level of control over ejaculation Very poor, Poor, Fair, Good, or Very Good?" The number of patients who rated their level of control over ejaculation before treatment and after 12 weeks of treatment with dapoxetine are provided in the table below.
Query!
Timepoint [1]
0
0
Baseline and Week 12
Query!
Secondary outcome [2]
0
0
The Patient's Level of Satisfaction With Intercourse
Query!
Assessment method [2]
0
0
The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of satisfaction with intercourse on a 5-point scale. Patients were asked: "Over the past month, was your satisfaction with sexual intercourse Very poor, Poor, Fair, Good, or Very Good?" The number of patients who rated their level of satisfaction with control over ejaculation at before treatment and after 12 weeks of treatment with dapoxetine are provided in the table below.
Query!
Timepoint [2]
0
0
Baseline and Week 12
Query!
Secondary outcome [3]
0
0
The Patient's Level of Personal Distress Related to the Speed of Ejaculation
Query!
Assessment method [3]
0
0
The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of distress related to the speed of ejaculation. Patient's were asked: "Over the past month, how distressed were you by how fast you ejaculated during sexual intercourse? Not at all, A little bit, Moderately, Quite a bit, Extremely." The number of patients who rated their level of personal distress related to the speed of ejaculation before treatment and after 12 weeks of treatment with dapoxetine are provided in the table below.
Query!
Timepoint [3]
0
0
Baseline and Week 12
Query!
Secondary outcome [4]
0
0
The Patient's Degree of Interpersonal Difficulty Related to the Speed of Ejaculation
Query!
Assessment method [4]
0
0
The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of interpersonal difficulty related to the speed of ejaculation. Patient's were asked: "Over the past month, to what extent did how fast you/your partner ejaculated during sexual intercourse cause difficulty in your relationship with your partner? Not at all, A little bit, Moderately, Quite a bit, or Extremely?" The number of patients who rated their level of interpersonal difficulty before treatment and after 12 weeks of treatment with dapoxetine are provided in the table below.
Query!
Timepoint [4]
0
0
Baseline and Week 12
Query!
Secondary outcome [5]
0
0
Patient Responses to Improvement With Their Premature Ejaculation After 12 Weeks of Treatment With Dapoxetine
Query!
Assessment method [5]
0
0
The "Clinical Global Impression of Change" (CGIC), a patient-reported scale was used to assess the patient's improvement with premature ejaculation (PE) since initiating treatment with dapoxetine. Patients were asked: "Compared to the start of the study, would you describe your premature ejaculation (PE) problem as: Much worse, Worse, Slightly worse, No change, Slightly better, Better, or Much better?" The number of patients reporting improvement in their PE by category of the CGIC scale after 12 weeks of treatment with dapoxetine are provided in the table below.
Query!
Timepoint [5]
0
0
Week 12
Query!
Secondary outcome [6]
0
0
The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least "Slightly Better" in Response to Dapoxetine Treatment (Subgroups by Dosage)
Query!
Assessment method [6]
0
0
The "Clinical Global Impression of Change" (CGIC) was used to assess the patient's improvement with premature ejaculation (PE) since initiating treatment with dapoxetine. The data provided below represent the number of patients who reported at least a slightly better response to treatment by the dose of dapoxetine they received in the study. This was a single-arm, open-label, non-randomized study in which "subgroup by dosage" was categorized based on dose-titration patterns observed during the course of the treatment period.
Query!
Timepoint [6]
0
0
Week 12
Query!
Secondary outcome [7]
0
0
The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least "Slightly Better" in Response to Dapoxetine Treatment (Subgroups by Disease Type)
Query!
Assessment method [7]
0
0
The "Clinical Global Impression of Change" (CGIC) was used to assess the patient's improvement with premature ejaculation (PE) since initiating treatment with dapoxetine. The data provided below represent the number of patients who reported at least a "slightly better" response to treatment when grouped by type of PE disease (patients with life-long PE and patients with acquired PE). This was a single-arm, open-label, non-randomized study where patients were categorized based their PE disease after enrollment in the study.
Query!
Timepoint [7]
0
0
Week 12
Query!
Secondary outcome [8]
0
0
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])
Query!
Assessment method [8]
0
0
The "Clinical Global Impression of Change" (CGIC) was used to assess the patient's improvement with premature ejaculation (PE) since initiating treatment with dapoxetine. The data provided below represent the number of patients who reported at least a "slightly better" response to treatment when grouped by intravaginal ejaculation latency time (patients with an IELT of < 1 minute and patients with an IELT of > 1 minute). This was a single-arm, open-label, non-randomized study where patients were categorized based on IELT after enrollment in the study.
Query!
Timepoint [8]
0
0
Week 12
Query!
Eligibility
Key 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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Males
Query!
Can healthy volunteers participate?
No
Query!
Key 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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
N/A
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/05/2010
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/06/2011
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
285
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
- Malvern
Query!
Recruitment hospital [2]
0
0
- St Leonards
Query!
Recruitment hospital [3]
0
0
- Sydney
Query!
Recruitment postcode(s) [1]
0
0
- Malvern
Query!
Recruitment postcode(s) [2]
0
0
- St Leonards
Query!
Recruitment postcode(s) [3]
0
0
- Sydney
Query!
Recruitment outside Australia
Country [1]
0
0
Korea, Republic of
Query!
State/province [1]
0
0
Busan
Query!
Country [2]
0
0
Korea, Republic of
Query!
State/province [2]
0
0
Daegu
Query!
Country [3]
0
0
Korea, Republic of
Query!
State/province [3]
0
0
Gwangju
Query!
Country [4]
0
0
Korea, Republic of
Query!
State/province [4]
0
0
Incheon
Query!
Country [5]
0
0
Korea, Republic of
Query!
State/province [5]
0
0
Jeonju-Si
Query!
Country [6]
0
0
Korea, Republic of
Query!
State/province [6]
0
0
Jinju-Si
Query!
Country [7]
0
0
Korea, Republic of
Query!
State/province [7]
0
0
Seoul
Query!
Country [8]
0
0
Thailand
Query!
State/province [8]
0
0
Bangkok
Query!
Country [9]
0
0
Thailand
Query!
State/province [9]
0
0
Chiang Mai
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Johnson & Johnson Pte Ltd
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT01063881
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Johnson & Johnson Pte. Ltd. Clinical Trial
Query!
Address
0
0
Johnson & Johnson Pte Ltd
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01063881
Download to PDF