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Trial registered on ANZCTR


Registration number
ACTRN12610000366055
Ethics application status
Not yet submitted
Date submitted
22/04/2010
Date registered
7/05/2010
Date last updated
7/05/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Relative Effectiveness of Treatments for Lifelong Premature Ejaculation among Heterosexual Men: Priligy and Combination Therapy
Scientific title
The effect of the medication Priligy versus an internet-based cognitive-behavourial therapy program versus a combination of both, on intra-vaginal ejaculation latency time, distress and sexual satisfaction in heterosexual men who have suffered from lifelong premature ejaculation.
Secondary ID [1] 251648 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lifelong Premature Ejaculation 257235 0
Condition category
Condition code
Renal and Urogenital 257372 257372 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Priligy (Dapoxetine Hydrochloride), internet-based cognitive-behavioural therapy (CBT) intervention.

Arm 1: Priligy Only- At the initial consultation, 30mg will be prescribed to be used at each sexual encounter according to the manufacturer's instructions. Participants will be given the option of increasing their dosage to 60mg if required, which will be assessed at the second consultation by the medical practitioner. Participants can take the dose at their discretion (not according to a specific schedule) and are instructed to take the oral capsule 1 to 3 hours before sexual activity.

Arm 2: CBT Program Only- Internet-based cognitive-behavioural therapy- 1 x 60 minutes per fortnight for 6 weeks. Online therapy sessions consist of 3 components: learning the 'stop-start' technique to control and/or delay his ejaculation, increase interpersonal communication and relationship factors, and unlimited email contact with a clinical psychologist to address issues of gaining/regaining confidence with their sexual performance, reducing performance anxiety, and addressing barriers with treatment. Each of the 3 modules build on the foundations of earlier modules, and are in a similar format: a list of goals to be achieved that module, communication exercises designed for the man to express his feelings about the program and relationship to his partner, information on the stop-start technique to delay ejaculation, and reminders of email contact with the psychologist. All modules concluded with a hurdle requirement which consisted of a list of statements that the man is required to agree with before they could continue. Once they passed the module, the man is provided with a password needed to access the next module.

Arm 3- Combination Treatment- Both Arm 1 and Arm 2 combined (i.e. the participant is required to partake in both Priligy and CBT treatment groups at the same time)
Intervention code [1] 256353 0
Treatment: Drugs
Intervention code [2] 256354 0
Treatment: Other
Comparator / control treatment
The control group will be heterosexual men with lifelong premature ejaculation who will receive the internet-based psychological treatment only
Control group
Active

Outcomes
Primary outcome [1] 258280 0
Increase in Intra-vaginal Ejaculation Latency Time (time it takes to ejaculate once penetration occurs as measured by the female partner with a stopwatch)
Timepoint [1] 258280 0
Questionnaires at baseline, post 12 weeks treatment, and at 3 month follow-up
Primary outcome [2] 258281 0
Increased control over ejaculation as measured on the Index of Premature Ejaculation questionnaire
Timepoint [2] 258281 0
Questionnaires at baseline, post 12 weeks treatment, and at 3 month follow-up
Primary outcome [3] 258282 0
Decrease in distress associated with lifelong premature ejaculation as measured on the Index of Premature Ejaculation questionnaire
Timepoint [3] 258282 0
Questionnaires at baseline, post 12 weeks treatment, and at 3 month follow-up
Secondary outcome [1] 263952 0
Increased relationship satisfaction as measured by single item question in questionnaire pack (i.e. How satisfied are you with your relationship?)
Timepoint [1] 263952 0
Questionnaires at baseline, post 12 weeks treatment, and at 3 month follow-up
Secondary outcome [2] 263991 0
Increase in sexual satisfaction as measured on the Index of Premature Ejaculation questionnaire
Timepoint [2] 263991 0
Questionnaires at baseline, post 12 weeks treatment, and at 3 month follow-up
Secondary outcome [3] 263992 0
Increase in self-esteem as shown in the Rosenberg (1965) self-esteem scale
Timepoint [3] 263992 0
Questionnaires at baseline, post 12 weeks treatment, and at 3 month follow-up
Secondary outcome [4] 263993 0
Increase in self confidence as measured by a single item (question) in questionnaire pack (i.e. How confident are you in your ability to perform sexually?)
Timepoint [4] 263993 0
Questionnaires at baseline, post 12 weeks treatment, and at 3 month follow-up

Eligibility
Key inclusion criteria
Heterosexual men who have lifelong premature ejaculation who are currently in a heterosexual relationship
Minimum age
20 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Men with aquired premature ejaculation, men with comorbid sexual dysfunction such as erectile dysfunction, men who currently use antidepressants, men who are not in a relationship.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Men who are deemed eligible for the study will be allocated to one of the treatment groups based on the order they present at the clinics.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2840 0
4163
Recruitment postcode(s) [2] 2841 0
2065

Funding & Sponsors
Funding source category [1] 256859 0
Commercial sector/Industry
Name [1] 256859 0
Janssen-Cilag
Country [1] 256859 0
New Zealand
Primary sponsor type
University
Name
Deakin University
Address
School of Psychology
221 Burwood Hwy,
Burwood, Vic
3810
Country
Australia
Secondary sponsor category [1] 256133 0
Commercial sector/Industry
Name [1] 256133 0
Janssen-Cilag
Address [1] 256133 0
Ground Floor,
105 Carlton Gore Rd,
Newmarket, 1023
Auckland
Country [1] 256133 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 258873 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 258873 0
Dean's Office, Faculty of Health, Medicine, Nursing and Behavioural Sciences
Level 3, Building E
221 Burwood Hwy
Burwood VIC 3125
Ethics committee country [1] 258873 0
Australia
Date submitted for ethics approval [1] 258873 0
28/04/2010
Approval date [1] 258873 0
Ethics approval number [1] 258873 0

Summary
Brief summary
The aim of the research is to evaluate the effectiveness of the following treatments for lifelong Premature Ejaculation (PE): (a) Priligy alone, (b) Cognitive-Behavioural Therapy (CBT) alone, and (b) Combined Priligy and CBT. The effectiveness of the interventions will be measured by pre and post treatment measures including intra-vaginal ejaculation latency time (IELT), distress, satisfaction with treatment, sexual satisfaction, relationship satisfaction, self-esteem, self confidence, masculinity, and partner sexual dysfunction. It is expected that all three treatments will be effective, but that the combination therapy will be more effective than Priligy alone or CBT alone in improving all of the above variables.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31085 0
Address 31085 0
Country 31085 0
Phone 31085 0
Fax 31085 0
Email 31085 0
Contact person for public queries
Name 14332 0
Prof. Marita McCabe
Address 14332 0
School of Psychology
221 Burwood Hwy
Burwood, Vic,
3125
Country 14332 0
Australia
Phone 14332 0
+61 3 92446856
Fax 14332 0
Email 14332 0
[email protected]
Contact person for scientific queries
Name 5260 0
Prof. Marita McCabe
Address 5260 0
School of Psychology
221 Burwood Hwy
Burwood, Vic,
3125
Country 5260 0
Australia
Phone 5260 0
+61 3 92446856
Fax 5260 0
Email 5260 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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