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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
The Asia-Pacific Flexible Dose Study of Dapoxetine and Patient Satisfaction in Premature Ejaculation Therapy
Secondary ID [1] 0 0
R096769PRE3009
Secondary ID [2] 0 0
CR016561
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sexual Dysfunction, Physiological 0 0
Condition category
Condition code
Reproductive Health and Childbirth 0 0 0 0
Complications of newborn
Reproductive Health and Childbirth 0 0 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Reproductive Health and Childbirth 0 0 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

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
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
The Patient's Level of Control Over Ejaculation
Timepoint [1] 0 0
Baseline and Week 12
Secondary outcome [2] 0 0
The Patient's Level of Satisfaction With Intercourse
Timepoint [2] 0 0
Baseline and Week 12
Secondary outcome [3] 0 0
The Patient's Level of Personal Distress Related to the Speed of Ejaculation
Timepoint [3] 0 0
Baseline and Week 12
Secondary outcome [4] 0 0
The Patient's Degree of Interpersonal Difficulty Related to the Speed of Ejaculation
Timepoint [4] 0 0
Baseline and Week 12
Secondary outcome [5] 0 0
Patient Responses to Improvement With Their Premature Ejaculation After 12 Weeks of Treatment With Dapoxetine
Timepoint [5] 0 0
Week 12
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)
Timepoint [6] 0 0
Week 12
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)
Timepoint [7] 0 0
Week 12
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])
Timepoint [8] 0 0
Week 12

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2011
Sample size
Target
Accrual to date
Final
285
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Malvern
Recruitment hospital [2] 0 0
- St Leonards
Recruitment hospital [3] 0 0
- Sydney
Recruitment postcode(s) [1] 0 0
- Malvern
Recruitment postcode(s) [2] 0 0
- St Leonards
Recruitment postcode(s) [3] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Korea, Republic of
State/province [1] 0 0
Busan
Country [2] 0 0
Korea, Republic of
State/province [2] 0 0
Daegu
Country [3] 0 0
Korea, Republic of
State/province [3] 0 0
Gwangju
Country [4] 0 0
Korea, Republic of
State/province [4] 0 0
Incheon
Country [5] 0 0
Korea, Republic of
State/province [5] 0 0
Jeonju-Si
Country [6] 0 0
Korea, Republic of
State/province [6] 0 0
Jinju-Si
Country [7] 0 0
Korea, Republic of
State/province [7] 0 0
Seoul
Country [8] 0 0
Thailand
State/province [8] 0 0
Bangkok
Country [9] 0 0
Thailand
State/province [9] 0 0
Chiang Mai

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Johnson & Johnson Pte Ltd
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01063881
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Johnson & Johnson Pte. Ltd. Clinical Trial
Address 0 0
Johnson & Johnson Pte Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01063881