Long-Term Safety and Efficacy Study of Avanafil in Men With Erectile Dysfunction
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00853606 |
|
Recruitment Status :
Completed
First Posted : March 2, 2009
Results First Posted : June 28, 2012
Last Update Posted : August 17, 2012
|
Sponsor:
VIVUS LLC
Information provided by (Responsible Party):
VIVUS LLC
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Brief Summary:
This open-label study is being conducted to evaluate the long-term safety, tolerability, and efficacy of avanafil in men with mild to severe erectile dysfunction. Approximately 400 subjects will be enrolled and treated with avanafil for up to 52 weeks.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Erectile Dysfunction | Drug: avanafil | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 712 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Open-Label, Long-Term Evaluation of the Safety and Efficacy of Avanafil in Men With Erectile Dysfunction |
| Study Start Date : | March 2009 |
| Actual Primary Completion Date : | April 2010 |
| Actual Study Completion Date : | April 2010 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Erectile Dysfunction
Drug Information available for:
Avanafil
| Arm | Intervention/treatment |
|---|---|
| Experimental: avanafil |
Drug: avanafil
All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with 100 mg may undergo dose reduction to 50 mg. Subjects who tolerate avanafil 100 mg but who desire increased efficacy may request a dose increase to 200 mg.
Other Names:
|
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. [ Time Frame: Baseline, 52 weeks ]Data presented as mean change from baseline and the treatment period 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?" Baseline is the run-in period from the qualifying study (TA-301/TA-302) consisting of all data reported during the non-treatment interval from Visit 1 to Visit 2. The treatment period is the on-treatment interval beginning with the first dose of study drug and ending on the last study visit.
- Change in Percentage of Sexual Attempts in Which Subjects Were Able to Insert the Penis Into the Partner's Vagina [ Time Frame: Baseline, 52 weeks ]Data presented as mean change from baseline and the treatment period 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?" Baseline is the run-in period from the qualifying study (TA-301/TA-302) consisting of all data reported during the non-treatment interval from Visit 1 to Visit 2. The treatment period is the on-treatment interval beginning with the first dose of study drug and ending on the last study visit.
- Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score [ Time Frame: Baseline, End of Treatment ]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. Baseline is the observation at Visit 2 of the qualifying study (TA-301/TA-302). End of treatment is the observation at Visit 8 of the last observation carried forward.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Successfully completed the entire treatment period in a qualifying study (TA-301 [NCT00790751] or TA-302 [NCT00809471]);
- Demonstrated compliance with the study protocol, including drug administration, diary completion, and scheduled study visits, during the qualifying trial;
- Made at least 4 attempts at intercourse during the last treatment period of the qualifying trial;
- Agree to make at least 4 attempts at intercourse each month through the course of this study;
- Agree not to use any other treatments for erectile dysfunction during participation in this study.
- Provide written informed consent;
- Willing and able to comply with scheduled study visits, treatment plan, laboratory tests, and other study procedures.
Exclusion Criteria:
- Subjects who, in the opinion of the investigator, have developed one or more comorbidities during the qualifying study that would pose a safety concern to their continuation on treatment in study TA-314;
- Subjects requiring treatment with an excluded medication.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00853606
Locations
| United States, Alabama | |
| Research Site | |
| Birmingham, Alabama, United States, 35209 | |
| Research Site | |
| Homewood, Alabama, United States, 35209 | |
| United States, Arizona | |
| Research Site | |
| Tucson, Arizona, United States, 85712 | |
| United States, California | |
| Research Site | |
| Sacramento, California, United States, 95821 | |
| Research Site | |
| San Diego, California, United States, 92120 | |
| Research Site | |
| San Diego, California, United States, 92123 | |
| United States, Connecticut | |
| Research Site | |
| Waterbury, Connecticut, United States, 06708 | |
| United States, Florida | |
| Research Site | |
| Clearwater, Florida, United States, 33756 | |
| Research Site | |
| Clearwater, Florida, United States, 33761 | |
| Research Site | |
| Coral Gables, Florida, United States, 33134 | |
| Research Site | |
| Hialeah, Florida, United States, 33012 | |
| Research Site | |
| Jacksonville, Florida, United States, 32205 | |
| Research Site | |
| Jupiter, Florida, United States, 33458 | |
| Research Site | |
| Ocala, Florida, United States, 34471 | |
| Research Site | |
| Pembroke Pines, Florida, United States, 33024 | |
| Research Site | |
| Ponte Vedra, Florida, United States, 32081 | |
| Research Site | |
| Tampa, Florida, United States, 33624 | |
| United States, Georgia | |
| Research Site | |
| Sandy Springs, Georgia, United States, 30328 | |
| United States, Kansas | |
| Research Site | |
| Wichita, Kansas, United States, 67205 | |
| United States, Kentucky | |
| Research Site | |
| Madisonville, Kentucky, United States, 42431 | |
| United States, Louisiana | |
| Research Site | |
| Shreveport, Louisiana, United States, 71106 | |
| United States, Missouri | |
| Research Site | |
| Kansas City, Missouri, United States, 64114 | |
| United States, New Jersey | |
| Research Site | |
| Lawrenceville, New Jersey, United States, 08648 | |
| United States, New York | |
| Research Site | |
| Albany, New York, United States, 12206 | |
| Research Site | |
| New York, New York, United States, 10016 | |
| United States, North Carolina | |
| Research Site | |
| Cary, North Carolina, United States, 27518 | |
| Research Site | |
| Charlotte, North Carolina, United States, 28207 | |
| Research Site | |
| Charlotte, North Carolina, United States, 28209 | |
| Research Site | |
| Harrisburg, North Carolina, United States, 28075 | |
| Research Site | |
| Hickory, North Carolina, United States, 28601 | |
| Research Site | |
| Raleigh, North Carolina, United States, 27609 | |
| Research Site | |
| Salisbury, North Carolina, United States, 28144 | |
| Research Site | |
| Wilmington, North Carolina, United States, 28401 | |
| Research Site | |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, Ohio | |
| Research Site | |
| Cleveland, Ohio, United States, 44122 | |
| United States, Pennsylvania | |
| Research Site | |
| Bala Cynwyd, Pennsylvania, United States, 19004 | |
| Research Site | |
| Lancaster, Pennsylvania, United States, 17601 | |
| United States, Texas | |
| Research Site | |
| El Paso, Texas, United States, 79935 | |
| Research Site | |
| Houston, Texas, United States, 77074 | |
| Research Site | |
| Spring, Texas, United States, 77386 | |
Sponsors and Collaborators
VIVUS LLC
Investigators
| Principal Investigator: | Andrew McCullough, MD | NYU Urology Associates |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | VIVUS LLC |
| ClinicalTrials.gov Identifier: | NCT00853606 |
| Other Study ID Numbers: |
TA-314 |
| First Posted: | March 2, 2009 Key Record Dates |
| Results First Posted: | June 28, 2012 |
| Last Update Posted: | August 17, 2012 |
| Last Verified: | August 2012 |
Keywords provided by VIVUS LLC:
|
ED Erectile Dysfunction Dysfunction Erectile |
Additional relevant MeSH terms:
|
Erectile Dysfunction Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Mental Disorders |