Research Evaluating an Investigational Medication for Erectile Dysfunction - Diabetic ED (REVIVE-D)
Study Details
Study Description
Brief Summary
This study is being conducted to compare the safety and efficacy of 2 doses of avanafil to placebo in diabetic men with mild to severe erectile dysfunction.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Placebo Comparator: placebo
|
Drug: placebo
30 minutes orally prior to initiation of sexual activity
|
Experimental: avanafil 100 mg
|
Drug: avanafil
30 minutes orally prior to initiation of sexual activity
Other Names:
|
Experimental: avanafil 200 mg
|
Drug: avanafil
30 minutes orally prior to initiation of sexual activity
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in Percentage of Sexual Attempts in Which Subjects Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse [Baseline, 12-weeks]
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?"
- Change in Percentage of Sexual Attempts in Which Subjects Were Able to Insert the Penis Into the Partner's Vagina [Baseline, 12 Weeks]
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?"
- Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score [Baseline, End of Treatment (up to 12 weeks)]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male subjects, age ≥ 18 years;
-
Minimum 6 month history of mild to severe erectile dysfunction;
-
Have documented diabetes (type 1 or type 2);
-
Subject is in a monogamous, heterosexual relationship for at least 3 months;
-
Subject agrees to make at least 4 attempts at intercourse per month;
-
Subject is willing and able to provide informed consent.
Exclusion Criteria:
-
Allergy or hypersensitivity to PDE5 inhibitors;
-
History of dose-limiting AEs during therapy with a PDE5 inhibitor or hx of consistent treatment failure with other PDE5 inhibitors for therapy of ED;
-
Current or expected use of organic nitrates at any time during the study;
-
Previous or current antiandrogen therapy;
-
Use of prescription or over-the-counter drugs known to inhibit the activity of CYP3A4 at any time during the study;
-
Androgen replacement therapy that has not been stable for at least 3 month;
-
Initiation or change in dose of any alpha-blocker within 14 days prior to randomization;
-
ED as a result of spinal cord injury or radical prostatectomy;
-
Untreated hypogonadism or low serum total testosterone
-
History of or predisposition to priapism;
-
Any penile implant;
-
Elevated PSA, other evidence of prostate cancer, or previous radical prostatectomy;
-
History of any malignancy (except basal cell carcinoma or squamous cell carcinoma of the skin successfully treated by curative excision);
-
Uncontrolled diabetes;
-
Uncontrolled hypertension;
-
Hypotension;
-
Orthostatic hypotension;
-
Significant cardiovascular disease;
-
Abnormal ECG;
-
Hepatic or renal impairment;
-
Positive STD screen;
-
Clinically evident penile lesions, abrasions, or anatomical deformities;
-
Urinary tract or bladder infection;
-
Use of any treatment for erectile dysfunction other than study drug at any time during the study;
-
Participation in another investigational study within 30 days of screening or at any time during this study;
-
Previous participation in any other investigational study of avanafil;
-
History or current drug, alcohol, or substance abuse;
-
Any history of bipolar disorder or psychosis, greater than one lifetime episode of major depression, current depression of moderate or greater severity or antidepressant use that has not been stable for at least 3 months;
-
Partners who are < 18 years of age, who are nursing, who are known to be pregnant at screening, who wish to become pregnant during the study period, who have any gynecologic problems or major medical conditions that would limit participation in sexual intercourse;
-
Evidence of any other condition by history, physical examination, or laboratory studies that, in the opinion of the investigator, would contraindicate the administration of study medication, affect compliance, interfere with study evaluations, limit study participation, contraindicate sexual activity, or confound the interpretation of study results.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Research Site | Birmingham | Alabama | United States | 35209 |
2 | Research Site | Homewood | Alabama | United States | 35209 |
3 | Research Site | Tucson | Arizona | United States | 85712 |
4 | Research Site | Sacramento | California | United States | 95821 |
5 | Research Site | San Diego | California | United States | 92120 |
6 | Research Site | San Diego | California | United States | 92123 |
7 | Research Site | Waterbury | Connecticut | United States | 06708 |
8 | Research Site | Clearwater | Florida | United States | 33756 |
9 | Research Site | Clearwater | Florida | United States | 33761 |
10 | Research Site | Coral Gables | Florida | United States | 33134 |
11 | Research Site | Hialeah | Florida | United States | 33012 |
12 | Research Site | Jacksonville | Florida | United States | 32205 |
13 | Research Site | Jacksonville | Florida | United States | 32259 |
14 | Research Site | Jupiter | Florida | United States | 33458 |
15 | Research Site | Ocala | Florida | United States | 34471 |
16 | Research Site | Pembroke Pines | Florida | United States | 33024 |
17 | Research Site | Tampa | Florida | United States | 33624 |
18 | Research Site | Atlanta | Georgia | United States | 30328 |
19 | Research Site | Wichita | Kansas | United States | 67205 |
20 | Research Site | Madisonville | Kentucky | United States | 42431 |
21 | Research Site | Shreveport | Louisiana | United States | 71106 |
22 | Research Site | Kansas City | Missouri | United States | 64114 |
23 | Research Site | Lawrenceville | New Jersey | United States | 08648 |
24 | Research Site | Albany | New York | United States | 12206 |
25 | Research Site | Cary | North Carolina | United States | 27518 |
26 | Research Site | Charlotte | North Carolina | United States | 28207 |
27 | Research Site | Charlotte | North Carolina | United States | 2829 |
28 | Research Site | Harrisburg | North Carolina | United States | 28075 |
29 | Research Site | Raleigh | North Carolina | United States | 27609 |
30 | Research Site | Salisbury | North Carolina | United States | 28144 |
31 | Research Site | Wilmington | North Carolina | United States | 28401 |
32 | Research Site | Winston-Salem | North Carolina | United States | 27103 |
33 | Research Site | Beachwood | Ohio | United States | 44122 |
34 | Research Site | Bala Cynwyd | Pennsylvania | United States | 19004 |
35 | Research Site | Lancaster | Pennsylvania | United States | 17601 |
36 | Research Site | El Paso | Texas | United States | 79935 |
37 | Research Site | Houston | Texas | United States | 77074 |
38 | Research Site | San Antonio | Texas | United States | 78229 |
39 | Research Site | Spring | Texas | United States | 77386 |
Sponsors and Collaborators
- VIVUS LLC
Investigators
- Principal Investigator: Irwin Goldstein, MD, San Diego Sexual Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TA-302
Study Results
Participant Flow
Recruitment Details | Subject recruitment occurred at US investigative sites between December 2008 and February 2010. |
---|---|
Pre-assignment Detail | 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 |
---|---|---|---|
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 |
Baseline Characteristics
Arm/Group Title | Placebo | Avanafil 100 mg | Avanafil 200 mg | Total |
---|---|---|---|---|
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 Participants | 130 | 129 | 131 | 390 |
Age (years) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [years] |
58.2
(8.62)
|
58.2
(9.62)
|
57.5
(8.99)
|
58.0
(9.07)
|
Sex: Female, Male (Count of Participants) | ||||
Female |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Male |
130
100%
|
129
100%
|
131
100%
|
390
100%
|
Region of Enrollment (participants) [Number] | ||||
United States |
130
100%
|
129
100%
|
131
100%
|
390
100%
|
Outcome Measures
Title | Change in Percentage of Sexual Attempts in Which Subjects Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Number of participants analyzed represents the Intent-to-Treat population. |
Arm/Group Title | Placebo | Avanafil 100 mg | Avanafil 200 mg |
---|---|---|---|
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 |
Measure Participants | 127 | 126 | 126 |
Least Squares Mean (Standard Error) [percentage of sexual attempts] |
13.6
(2.77)
|
28.7
(2.78)
|
34.0
(2.76)
|
Title | Change in Percentage of Sexual Attempts in Which Subjects Were Able to Insert the Penis Into the Partner's Vagina |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Number of participants analyzed represents the Intent-to-Treat population. |
Arm/Group Title | Placebo | Avanafil 100 mg | Avanafil 200 mg |
---|---|---|---|
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 |
Measure Participants | 127 | 126 | 126 |
Least Squares Mean (Standard Error) [percentage of sexual attempts] |
7.5
(2.85)
|
21.5
(2.85)
|
25.9
(2.90)
|
Title | Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score |
---|---|
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) |
Outcome Measure Data
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 |
---|---|---|---|
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 |
Measure Participants | 125 | 125 | 125 |
Least Squares Mean (Standard Deviation) [scores on a scale] |
1.8
(0.64)
|
4.5
(0.64)
|
5.4
(0.66)
|
Adverse Events
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 | |||
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 (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
Placebo | Avanafil 100 mg | Avanafil 200 mg | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 1/130 (0.8%) | 3/127 (2.4%) | 4/131 (3.1%) | |||
Cardiac disorders | ||||||
angina unstable | 0/130 (0%) | 0/127 (0%) | 1/131 (0.8%) | |||
Infections and infestations | ||||||
urinary tract infection | 0/130 (0%) | 1/127 (0.8%) | 0/131 (0%) | |||
localised infection | 0/130 (0%) | 1/127 (0.8%) | 0/131 (0%) | |||
pneumonia | 0/130 (0%) | 0/127 (0%) | 1/131 (0.8%) | |||
Injury, poisoning and procedural complications | ||||||
spinal compression fracture | 1/130 (0.8%) | 0/127 (0%) | 0/131 (0%) | |||
Musculoskeletal and connective tissue disorders | ||||||
pain in extremity | 0/130 (0%) | 0/127 (0%) | 1/131 (0.8%) | |||
muscular weakness | 0/130 (0%) | 0/127 (0%) | 1/131 (0.8%) | |||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
bladder cancer | 0/130 (0%) | 0/127 (0%) | 1/131 (0.8%) | |||
Vascular disorders | ||||||
deep vein thrombosis | 0/130 (0%) | 1/127 (0.8%) | 0/131 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
Placebo | Avanafil 100 mg | Avanafil 200 mg | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 12/130 (9.2%) | 18/127 (14.2%) | 27/131 (20.6%) | |||
Gastrointestinal disorders | ||||||
dyspepsia | 0/130 (0%) | 0/127 (0%) | 4/131 (3.1%) | |||
Infections and infestations | ||||||
nasopharyngitis | 6/130 (4.6%) | 4/127 (3.1%) | 4/131 (3.1%) | |||
sinusitis | 0/130 (0%) | 4/127 (3.1%) | 1/131 (0.8%) | |||
influenza | 0/130 (0%) | 3/127 (2.4%) | 0/131 (0%) | |||
Musculoskeletal and connective tissue disorders | ||||||
back pain | 3/130 (2.3%) | 2/127 (1.6%) | 1/131 (0.8%) | |||
Nervous system disorders | ||||||
headache | 2/130 (1.5%) | 5/127 (3.9%) | 15/131 (11.5%) | |||
Respiratory, thoracic and mediastinal disorders | ||||||
sinus congestion | 1/130 (0.8%) | 1/127 (0.8%) | 4/131 (3.1%) | |||
Vascular disorders | ||||||
flushing | 0/130 (0%) | 2/127 (1.6%) | 5/131 (3.8%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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 |
- TA-302