clinical trial on erectile dysfunction 151110

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CLINICAL TRIAL ON ERECTILE DYSFUNCTION case study K.UPENDRA REDDY 2010H146037H

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Page 1: Clinical trial on erectile dysfunction 151110

CLINICAL TRIAL ON ERECTILE DYSFUNCTION

case study

K.UPENDRA REDDY2010H146037H

Page 2: Clinical trial on erectile dysfunction 151110

OFFICIAL TITLE

Tadalafil 5 mg Once a Day Compared to Placebo in Improving Erectile Dysfunction and Sexual

Quality of Life

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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

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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

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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.

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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

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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.

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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)

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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.

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RECRUITEMENT INFORMATION

Recruitment Status

completed

Enrollment 342

Start date November 2006

Primary Completion Date

January 2008

Completion Date January 2008

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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

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PARTICIPANT FLOW

Placebo Tadalafil

Started 78 264

Completed 64 243

Not completedPhysician decisionProtocol violationWithdrawal by subjectsAdverse eventsPartner decision

14111200

2116833

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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

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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

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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

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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

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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

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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

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Statistical Analysis to measure outcomes

Groups All groups

Method ANCOVA

P-value <0.001

Significance level 0.025

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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

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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

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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

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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?

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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)?

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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?

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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

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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

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REFERENCES:

http://clinicaltrials.gov/ct2/show/results/NCT00422734?term=erectile+dysfunction&sect=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

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THANK YOU

“Keep that Spark Alive”