clinical trial on erectile dysfunction 151110
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CLINICAL TRIAL ON ERECTILE DYSFUNCTION
case study
K.UPENDRA REDDY2010H146037H
OFFICIAL TITLE
Tadalafil 5 mg Once a Day Compared to Placebo in Improving Erectile Dysfunction and Sexual
Quality of Life
Sponsor Eli Lilly and Company
collaborator ICOS corporation
information provided by Eli Lilly and Company
ClinicalTrials.gov Identifier NCT00422734
STUDY LOCATIONS: United States, Austria ,France,
Germany,Mexico
PURPOSE
To evaluate the effect of tadalafil on sexual quality of life
To evaluate the effect of tadalafil on Erectile Dysfunction
condition intervention
phase
Impotency Drug: placeboDrug: Tadalafil
Phase III
Study Type: Interventional
Study Design: Allocation: Randomized.
Control: Placebo Control.
Endpoint Classification: Safety/Efficacy Study.
Intervention Model: Parallel Assignment.
Masking: Double Blind (Subject, Investigator).
Primary Purpose: Treatment.
Eligibility
Ages Eligible for Study: 18 Years and older. Genders Eligible for Study: Male. Accepts Healthy Volunteers: No.
Inclusion criteria: History of erectile dysfunction (ED) for at least 3
months duration Anticipate to have the same female partner willing to
participate throughout the study At least 18 years of age at Visit 1 and agree to make at
least 4 sexual attempts during the early phase of the study
Adequate partner sexual function as determined by a Female Sexual Function Index
Willing to record responses to efficacy questionnaires, sexual quality of life questionnaires and other instruments used in the study
Exclusion criteria:
May not participate in the study if you taken tadalafil previously.
History of cardiac conditions including angina requiring treatment with nitrates, heart disease of coronary conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for specified time before starting the study.
With a sexual partner not willing to complete the scales.
Use of nitrates.
OUTCOME MEASURES
Primary outcome measures:Change From Baseline to Endpoint in the
International Index of Erectile Function (IIEF)- Erectile Function Domain Score
Improvement in the Sexual Quality of Life in the Subject and His Study Partner as Measured by the Sexual Quality of Life (SQoL) Domain of the Sexual Life Quality Questionnaire (SLQQ)
Change From Baseline to Endpoint in the Percent of "Yes" Responses to Sexual Encounter Profile (SEP) Diary Questions 2 (SEP2) and 3 (SEP3)
Secondary outcome measures
Intercourse Satisfaction Domain - Subject Response.
Female Sexual Function Index (FSFI) - Partner Response.
Overall Satisfaction Domain of the International Index of Erectile Function (IIEF-OS) - Subject Response.
Sexual Encounter Profile (SEP) Questions 1 - 5 –Subject & Partner Response.
RECRUITEMENT INFORMATION
Recruitment Status
completed
Enrollment 342
Start date November 2006
Primary Completion Date
January 2008
Completion Date January 2008
ARMS ASSIGNED INTERVENTIONS
1: Placebo Comparator Drug: Placebo placebo tablet taken orally once a day for 12 weeks
2: Active Comparator Drug: tadalafil
5 mg tadalafil tablet taken orally once a day for 12 weeks
PARTICIPANT FLOW
Placebo Tadalafil
Started 78 264
Completed 64 243
Not completedPhysician decisionProtocol violationWithdrawal by subjectsAdverse eventsPartner decision
14111200
2116833
BASELINE CHARACTERISTICS
Placebo Tadalafil Total
No of participants
78 264 342
Age 53.82 ± 10.72 54.42 ± 10.04
54.29 ± 10.18
ED duration>= 1 year
3 to 6 months 6 months to 1
yr
7314
24816
313920
ED severityMild (17-30)
Moderate (11-16)
Severe (1-10)Missing
3522201
12371637
15893838
IIEF domain score
[units: units on a scale]
Mean ± Standard Deviation
15.27 ± 6.49 15.73 ± 6.13
15.62 ± 6.21
OUTCOME MEASURES
Primary outcomes1. Change From Baseline to Endpoint in the
International Index of Erectile Function (IIEF)- Erectile Function Domain Score (Sum of IIEF Questions 1-5 and 15) [ Time Frame: Baseline and 12 weeks ] Placebo Tadalafil
Participants Analyzed 72 244
Change in Erectile Function Domain Score[units: units on a scale]Least Squares Mean ± Standard Error
0.49 ± 0.781 8.03 ± 0.449
2. Improvement in the Sexual Quality of Life in the Subject and His Study Partner as Measured by the Sexual Quality of Life (SQoL) Domain of the Sexual Life Quality Questionnaire (SLQQ) [ Time Frame: Baseline and 12 weeks ]Placebo Tadalafil
Participants Analyzed
72 244
Improvement in the Sexual Quality of Life [units: units on a scale]Least Squares Mean ± Standard Error
SQoL - Subject
SQoL - partner
12.59 ± 2.866 7.93 ± 2.861
39.37 ± 1.651
32.87 ± 1.638
3. Change From Baseline to Endpoint in the Percent of "Yes" Responses to Sexual Encounter Profile (SEP) Diary Questions 2 (SEP2) and 3 (SEP3). [ Time Frame: Baseline and 12 weeks ]
Placebo Tadalafil
Participants Analyzed
Change in the Percent of "Yes" Responses to Sexual Encounter Profile (SEP)
Question 2
Question 3
2.19 ± 2.833
10.80 ± 3.767
28.80 ± 1.644
46.46 ± 2.185
Secondary outcome measures
1. Change From Baseline to Week 12 Endpoint in the International Index of Erectile Function - Intercourse Satisfaction Domain - Subject Response [ Time Frame: Baseline and 12 weeks ]
Placebo Tadalafil
Participants Analyzed 72 244
Change in Intercourse Satisfaction Domain
0.09 ± 0.356 2.74 ± 0.205
2. Change From Baseline to 12 Week Endpoint in Overall Satisfaction Domain of the International Index of Erectile Function (IIEF-OS) - Subject Response [ Time Frame: Baseline and 12 weeks ]
Placebo Tadalafil
Participants Analyzed 72 244
Change in Overall Satisfaction Domain
0.44 ± 0.257 2.57 ± 0.148
Statistical Analysis to measure outcomes
Groups All groups
Method ANCOVA
P-value <0.001
Significance level 0.025
Serious adverse eventsPlacebo Tadalafil
Total, Adverse events # participants affected
1 3
Pancreatitis 1/78 0/264
Hypersensitivity 0/78 1/264
Gastroenteritis 0/78 1/264
Cerebrovascular accident
0/78 1/264
Other adverse eventsEvent Placebo Tadalafil
Headache 4 26
Dyspepsia 0 13
Nasal congestion 0 9
Diarrhoea 1 5
Painful erection 0 5
Pharyngitis 1 4
Nausea 0 3
Questionnaire
The International Index of Erectile Function
Questionnaire (IIEF)
1.Over the last month, how often were you able to get an erection during sexual activity?
0 No sexual activity 5 Almost always or always 4 Most times (much more than half the time) 3 Sometimes (about half the time) 2 A few times (much less than half the time) 1 Almost never or never
2. Over the last month, when you had erections with sexual stimulation, how often were your erections hard enough for penetration?
3. Over the last month, when you attempted intercourse, how often were you able to penetrate your partner?
4. Over the last month, during sexual intercourse, how often were you able to maintain your erection after you had penetrated your partner?
5. Over the last month, during sexual intercourse, how difficult was it to maintain your erection to completion of intercourse?
6. Over the last month, how many times have you attempted sexual intercourse?
7. Over the last month, when you attempted sexual intercourse how often was it satisfactory for you?
8. Over the last month, how much have you enjoyed sexual intercourse?
9. Over the last month, when you had sexual stimulation or intercourse, how often did you ejaculate?
10. Over the last month, when you had sexual stimulation or intercourse, how often did you have the feeling of orgasm (with or without ejaculation)?
11. Over the last month, how often have you felt sexual desire?
12. Over the last month, how would you rate your level of sexual desire?
13. Over the last month, how satisfied have you been with your overall sex life?
14. Over the last month, how satisfied have you been with your sexual relationship with your partner?
15. Over the last month, how do you rate your confidence that you can get and keep your erection?
Area Questions
ScoreRange
MaximumScore
YourScore
Erectile function
1-5, 15 0-5 30
Orgasmic funtion
9, 10 0-5 10
Sexual desire
11-12 1-5 10
Intercourse satisfaction
6-8 0-5 15
Overall satisfaction
13-14 1-5 10
CONCLUSION:
Integrated analysis of data from phase III trial demonstrated that tadalafil at dose 5 mg significantly improved erectile function (vs placebo) by all efficacy measures.
Improved quality of life
Tadalafil was safe and well tolerated in the phase III studies, with headache and dyspepsia being the most frequent adverse events
REFERENCES:
http://clinicaltrials.gov/ct2/show/results/NCT00422734?term=erectile+dysfunction§=X0125#all
http://www.seekwellness.com/mensexuality/questionnaire.htm
http://en.wikipedia.org/wiki/Impotence
http://www.healthcentral.com/erectile-dysfunction/understanding-erectile-dysfunction-44026-47.html
THANK YOU
“Keep that Spark Alive”
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