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Research Evaluating an Investigational Medication for Erectile Dysfunction - Diabetic ED (REVIVE-D) (REVIVE-D)

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ClinicalTrials.gov Identifier: NCT00809471
Recruitment Status : Completed
First Posted : December 17, 2008
Results First Posted : June 28, 2012
Last Update Posted : August 17, 2012
Sponsor:
Information provided by (Responsible Party):
VIVUS, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Erectile Dysfunction
Interventions Drug: placebo
Drug: avanafil
Enrollment 390

Recruitment Details Subject recruitment occurred at US investigative sites between December 2008 and February 2010.
Pre-assignment Details Subjects meeting the initial eligibility criteria completed a 4-week non-treatment run-in period during which information on each attempt at intercourse was recorded. At the end of the run-in, subjects meeting the randomization criteria were eligible for assignment to one of the treatment groups.
Arm/Group Title Placebo Avanafil 100 mg Avanafil 200 mg
Hide Arm/Group Description placebo 30 minutes orally prior to initiation of sexual activity avanafil 100 mg 30 minutes orally prior to initiation of sexual activity avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
Period Title: Overall Study
Started 130 129 131
Completed 110 109 114
Not Completed 20 20 17
Reason Not Completed
Protocol non-compliance             15             15             6
Lost to Follow-up             4             2             9
Adverse Event             0             2             2
Requirement for restricted medication             1             1             0
Arm/Group Title Placebo Avanafil 100 mg Avanafil 200 mg Total
Hide Arm/Group Description placebo 30 minutes orally prior to initiation of sexual activity avanafil 100 mg 30 minutes orally prior to initiation of sexual activity avanafil 200 mg 30 minutes orally prior to initiation of sexual activity Total of all reporting groups
Overall Number of Baseline Participants 130 129 131 390
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 130 participants 129 participants 131 participants 390 participants
58.2  (8.62) 58.2  (9.62) 57.5  (8.99) 58.0  (9.07)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 130 participants 129 participants 131 participants 390 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
130
 100.0%
129
 100.0%
131
 100.0%
390
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 130 participants 129 participants 131 participants 390 participants
130 129 131 390
1.Primary Outcome
Title Change in Percentage of Sexual Attempts in Which Subjects Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse
Hide Description Data presented as mean change from baseline in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 3 "Did your erection last long enough for you to have successful intercourse?"
Time Frame Baseline, 12-weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed represents the Intent-to-Treat population.
Arm/Group Title Placebo Avanafil 100 mg Avanafil 200 mg
Hide Arm/Group Description:
placebo 30 minutes orally prior to initiation of sexual activity
avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
Overall Number of Participants Analyzed 127 126 126
Least Squares Mean (Standard Error)
Unit of Measure: percentage of sexual attempts
13.6  (2.77) 28.7  (2.78) 34.0  (2.76)
2.Primary Outcome
Title Change in Percentage of Sexual Attempts in Which Subjects Were Able to Insert the Penis Into the Partner's Vagina
Hide Description Data presented as mean change from baseline in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 2 "Were you able to insert your penis into your partner's vagina?"
Time Frame Baseline, 12 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed represents the Intent-to-Treat population.
Arm/Group Title Placebo Avanafil 100 mg Avanafil 200 mg
Hide Arm/Group Description:
placebo 30 minutes orally prior to initiation of sexual activity
avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
Overall Number of Participants Analyzed 127 126 126
Least Squares Mean (Standard Error)
Unit of Measure: percentage of sexual attempts
7.5  (2.85) 21.5  (2.85) 25.9  (2.90)
3.Primary Outcome
Title Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score
Hide Description Questionnaire assesses subject's evaluation of erectile function over the previous 4-week period. Total score from questions 1-5 & 15 ranges from 1 to 30. A higher score indicates better erectile function.
Time Frame Baseline, End of Treatment (up to 12 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed represents the Intent-to-Treat population. For dropouts or missing data, the last observation carried forward convention was used.
Arm/Group Title Placebo Avanafil 100 mg Avanafil 200 mg
Hide Arm/Group Description:
placebo 30 minutes orally prior to initiation of sexual activity
avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
Overall Number of Participants Analyzed 125 125 125
Least Squares Mean (Standard Deviation)
Unit of Measure: scores on a scale
1.8  (0.64) 4.5  (0.64) 5.4  (0.66)
Time Frame AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
Adverse Event Reporting Description # participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
 
Arm/Group Title Placebo Avanafil 100 mg Avanafil 200 mg
Hide Arm/Group Description placebo 30 minutes orally prior to initiation of sexual activity avanafil 100 mg 30 minutes orally prior to initiation of sexual activity avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
All-Cause Mortality
Placebo Avanafil 100 mg Avanafil 200 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Avanafil 100 mg Avanafil 200 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/130 (0.77%)   3/127 (2.36%)   4/131 (3.05%) 
Cardiac disorders       
angina unstable  1  0/130 (0.00%)  0/127 (0.00%)  1/131 (0.76%) 
Infections and infestations       
urinary tract infection  1  0/130 (0.00%)  1/127 (0.79%)  0/131 (0.00%) 
localised infection  1  0/130 (0.00%)  1/127 (0.79%)  0/131 (0.00%) 
pneumonia  1  0/130 (0.00%)  0/127 (0.00%)  1/131 (0.76%) 
Injury, poisoning and procedural complications       
spinal compression fracture  1  1/130 (0.77%)  0/127 (0.00%)  0/131 (0.00%) 
Musculoskeletal and connective tissue disorders       
pain in extremity  1  0/130 (0.00%)  0/127 (0.00%)  1/131 (0.76%) 
muscular weakness  1  0/130 (0.00%)  0/127 (0.00%)  1/131 (0.76%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
bladder cancer  1  0/130 (0.00%)  0/127 (0.00%)  1/131 (0.76%) 
Vascular disorders       
deep vein thrombosis  1  0/130 (0.00%)  1/127 (0.79%)  0/131 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo Avanafil 100 mg Avanafil 200 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   12/130 (9.23%)   18/127 (14.17%)   27/131 (20.61%) 
Gastrointestinal disorders       
dyspepsia  1  0/130 (0.00%)  0/127 (0.00%)  4/131 (3.05%) 
Infections and infestations       
nasopharyngitis  1  6/130 (4.62%)  4/127 (3.15%)  4/131 (3.05%) 
sinusitis  1  0/130 (0.00%)  4/127 (3.15%)  1/131 (0.76%) 
influenza  1  0/130 (0.00%)  3/127 (2.36%)  0/131 (0.00%) 
Musculoskeletal and connective tissue disorders       
back pain  1  3/130 (2.31%)  2/127 (1.57%)  1/131 (0.76%) 
Nervous system disorders       
headache  1  2/130 (1.54%)  5/127 (3.94%)  15/131 (11.45%) 
Respiratory, thoracic and mediastinal disorders       
sinus congestion  1  1/130 (0.77%)  1/127 (0.79%)  4/131 (3.05%) 
Vascular disorders       
flushing  1  0/130 (0.00%)  2/127 (1.57%)  5/131 (3.82%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
After Sponsor's written notification that publication of results is no longer planned or 12 months after termination of the study at all sites, Institution & PI may publish, upon written approval from Sponsor, results of the Study. Sponsor will be given the opportunity to review any proposed publication at least 60 days prior to submission for publication or disclosure. Upon Sponsor's written request, Institution and PI shall not publish or disclose information related to the Study.
Results Point of Contact
Name/Title: Wesley W Day PhD
Organization: Vivus, Inc
Phone: 650-934-5200
Responsible Party: VIVUS, Inc.
ClinicalTrials.gov Identifier: NCT00809471     History of Changes
Other Study ID Numbers: TA-302
First Submitted: December 15, 2008
First Posted: December 17, 2008
Results First Submitted: May 25, 2012
Results First Posted: June 28, 2012
Last Update Posted: August 17, 2012