Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00498680
Status:
UNKNOWN
Last Update Posted:
2010-10-22
First Post:
2007-07-08
Brief Title:
Safety and Clinical Effectiveness of 2 Lower Dose Combined PDE5is vs Single Maximal Dose PDE5i
Sponsor:
Rambam Health Care Campus
Organization:
Rambam Health Care Campus
Study Overview
Official Title:
A Prospective Randomized 3-arm Parallel Trial to Evaluate the Safety and Clinical Effectiveness of 2 Lower Dose Combined PDE5is vs Single Maximal Dose PDE5i Treatment
Status:
UNKNOWN
Status Verified Date:
2007-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A prospective randomized 3-arm parallel trial on 45 males with ED that were never exposed to PDE5i therapy naïve patients will be enrolledIn each group every patient will receive three treatment regimes Viagra50mg Levitra10mg Viagra100mg Levitra20mg in different sequences of administration in such a manner that eventually each patient will receive all regimes in a double- blinded fasionSafety will be evaluated at pre- screening by measuring hourly vital signs blood pressure heart ratefor 4 consecutive hours after taking half-dose combination Any decrease in blood pressure of 20 mmhg below baseline will exclude the subject from the study Effcacy will be evaluated by questionnaires IIEF Quality of erection questionnaire grade of erection scale Sear QVS and Sexual Encounter Profiles for each sexual event Non-parametric statistical analysis of the collected data Comparing the 3 groups will be performed
Detailed Description:
A prospective randomized 3-arm parallel trial on 45 males with ED that were never exposed to PDE5i therapy naïve patients will be enrolled Recruitment will be performed via advertisement or by offering newly diagnosed naïve ED patients visiting the clinic to participate in the study
In each group every patient will receive three treatment regimes Viagra50mg Levitra10mg Viagra100mg Levitra20mg in different sequences of administration as follows
Group 1 15 naïve patients will start with Viagra100mg continue with Levitra20mg and end the study with combined Viagra50mg Levitra10mg
Group 2 15 naïve patients will start with combined Viagra50mg Levitra10mg continue with Levitra20mg and end the study with Viagra100mg
Group 3 15 naïve patients will start with Levitra20mg continue with Viagra100mg and end the study with combined Viagra50mg Levitra10mg
Inclusion criteria - Relationship with the same partner for at least 3 month
Age ranging between 35-65 years old
Sexually active minimal frequency of one sexual encounter per 2 weeks
IIEF ED domain score 22 and below Exclusion criteria - Subjects with premature ejaculation as their main sexual complaint
Subjects with severe cardiovascular disease in the past 6 months including cardiac failure myocardial infarction unstable angina stroke or transient ischemic attack symptomatic or clinically significant cardiac arrhythmias including atrial fibrillation
Subjects with Contraindications to PDE5i therapy Namely patients receiving treatment with nitrate based medication or patients that for various reasons cannot take PDE5 inhibitors severe hepatic diseases- cirrhosis or ALT Alanine aminotransferase2x upper limit of normal renal impairment creatinine clearance 30mlmin or known hereditary degenerative retinal disorders such as retinitis pigmentosa
Concomitant treatment with potent CYP3A4 and CYP2C9 inhibitors eg protease inhibitors ritonavir and saquinavir ketoconazole itrakonazole miconazole nefazodone claritromycin troleandomycin erythromycin and cimetidine
Subjects mentally unfit for the study
SAFETY ELIGIBILITY VISIT After a thorough explanation of the nature of the study and its protocol and after understanding and signing the informed consent form In this visit each subject will start the study by measuring basic blood pressure levels and pulse rate Under our supervision the subject will take the combined half dose as suggested Blood pressure monitoring and pulse rate every half- hour at the clinic will be performed for 4 hours according to the pharmacokinetic properties of the medications Any recordings of 20 mmhg below baseline will exclude the subject from the study If no significant effect on blood pressure will be noted the subject will be eligible for inclusion in the study and will be invited for the FIRST visit 7 days later a washout period of one week is sufficient to eliminate any effect of one-time dosing of the combined half dose treatment Each included patient in the coming 6 visits will respond to the following pre-set sexual function and satisfaction questionnaires Hebrew validated
1 The full IIEF International Index Erectile Function standard Questionnaire
2 The SEAR Self-Esteem And Relationship questionnaire
3 QVS Quality of Sexual Life questionnaire
4 Quality of erection questionnaire
5 Grade of erection scale
At each visit documentation of side-effects will be done and a physical examination blood pressure and pulse rate will be done A 24 hour mobile phone dedicated to patient inquiries will be provided to each patient during the whole study
Visit 1 The subject will be offered at random for 4 attempts at home either a combination dose regime Viagra50mg Levitra10mg 4 tablets each or 4 tablets of Viagra100mg single dose or 4 tablets of Levitra 20 mg The subject will also receive 6 SEP Sexual Encounter Profile diaries to fill out at home after each sexual attempt After 4 attempts the subject will return for visit 2 will respond to the same questionnaires and an additional EDITS Erectile Dysfunction Inventory of Treatment Satisfaction questionnaire A new visit will be rescheduled for 2 weeks later to allow a washout period At visit 3 they will receive the 2nd regime and 4 new SEP diaries and after 4 attempts will return to visit 4 fill out the same 4 questionnaires Again a new visit will be rescheduled for 2 weeks later to allow a washout period On visit 5 they will return to receive the third treatment regime Again they will receive 4 SEP diaries to fill out after each sexual attempt at home At their final visit visit 6 in addition to the other 4 questionnaires the patients will be required to respond to a preference questionnaire regarding the preferred regime
The approximate timeline for performing the study for every patient is 12 a year from recruitment The estimated timeline for completion of the study is 16 months
Only on inclusion
Washout period 2 weeks
Non-parametric statistical analysis of the collected data from the questionnaires will be performed
In each group every patient will receive three treatment regimes Viagra50mg Levitra10mg Viagra100mg Levitra20mg in different sequences of administration as follows
Group 1 15 naïve patients will start with Viagra100mg continue with Levitra20mg and end the study with combined Viagra50mg Levitra10mg
Group 2 15 naïve patients will start with combined Viagra50mg Levitra10mg continue with Levitra20mg and end the study with Viagra100mg
Group 3 15 naïve patients will start with Levitra20mg continue with Viagra100mg and end the study with combined Viagra50mg Levitra10mg
Inclusion criteria - Relationship with the same partner for at least 3 month
Age ranging between 35-65 years old
Sexually active minimal frequency of one sexual encounter per 2 weeks
IIEF ED domain score 22 and below Exclusion criteria - Subjects with premature ejaculation as their main sexual complaint
Subjects with severe cardiovascular disease in the past 6 months including cardiac failure myocardial infarction unstable angina stroke or transient ischemic attack symptomatic or clinically significant cardiac arrhythmias including atrial fibrillation
Subjects with Contraindications to PDE5i therapy Namely patients receiving treatment with nitrate based medication or patients that for various reasons cannot take PDE5 inhibitors severe hepatic diseases- cirrhosis or ALT Alanine aminotransferase2x upper limit of normal renal impairment creatinine clearance 30mlmin or known hereditary degenerative retinal disorders such as retinitis pigmentosa
Concomitant treatment with potent CYP3A4 and CYP2C9 inhibitors eg protease inhibitors ritonavir and saquinavir ketoconazole itrakonazole miconazole nefazodone claritromycin troleandomycin erythromycin and cimetidine
Subjects mentally unfit for the study
SAFETY ELIGIBILITY VISIT After a thorough explanation of the nature of the study and its protocol and after understanding and signing the informed consent form In this visit each subject will start the study by measuring basic blood pressure levels and pulse rate Under our supervision the subject will take the combined half dose as suggested Blood pressure monitoring and pulse rate every half- hour at the clinic will be performed for 4 hours according to the pharmacokinetic properties of the medications Any recordings of 20 mmhg below baseline will exclude the subject from the study If no significant effect on blood pressure will be noted the subject will be eligible for inclusion in the study and will be invited for the FIRST visit 7 days later a washout period of one week is sufficient to eliminate any effect of one-time dosing of the combined half dose treatment Each included patient in the coming 6 visits will respond to the following pre-set sexual function and satisfaction questionnaires Hebrew validated
1 The full IIEF International Index Erectile Function standard Questionnaire
2 The SEAR Self-Esteem And Relationship questionnaire
3 QVS Quality of Sexual Life questionnaire
4 Quality of erection questionnaire
5 Grade of erection scale
At each visit documentation of side-effects will be done and a physical examination blood pressure and pulse rate will be done A 24 hour mobile phone dedicated to patient inquiries will be provided to each patient during the whole study
Visit 1 The subject will be offered at random for 4 attempts at home either a combination dose regime Viagra50mg Levitra10mg 4 tablets each or 4 tablets of Viagra100mg single dose or 4 tablets of Levitra 20 mg The subject will also receive 6 SEP Sexual Encounter Profile diaries to fill out at home after each sexual attempt After 4 attempts the subject will return for visit 2 will respond to the same questionnaires and an additional EDITS Erectile Dysfunction Inventory of Treatment Satisfaction questionnaire A new visit will be rescheduled for 2 weeks later to allow a washout period At visit 3 they will receive the 2nd regime and 4 new SEP diaries and after 4 attempts will return to visit 4 fill out the same 4 questionnaires Again a new visit will be rescheduled for 2 weeks later to allow a washout period On visit 5 they will return to receive the third treatment regime Again they will receive 4 SEP diaries to fill out after each sexual attempt at home At their final visit visit 6 in addition to the other 4 questionnaires the patients will be required to respond to a preference questionnaire regarding the preferred regime
The approximate timeline for performing the study for every patient is 12 a year from recruitment The estimated timeline for completion of the study is 16 months
Only on inclusion
Washout period 2 weeks
Non-parametric statistical analysis of the collected data from the questionnaires will be performed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None