Long-Term Safety and Efficacy Study of Avanafil in Men With Erectile Dysfunction

• Sponsor: VIVUS LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00853606
• Collaborator: (none)
• Enrollment: 712
• Locations: 40
• Arm: 1
• Duration (Months): 13
• Patients Per Site: 17.8
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Mar 1, 2009
• Actual Primary Completion Date: Apr 1, 2010
• Actual Study Completion Date: Apr 1, 2010

Arms and Interventions

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: TA-1790 Stendra

Outcome Measures

Primary Outcome Measures

1. Change in Percentage of Sexual Attempts in Which Subjects Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse. [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.

2. Change in Percentage of Sexual Attempts in Which Subjects Were Able to Insert the Penis Into the Partner's Vagina [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.

3. Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

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	Jupiter	Florida	United States	33458
14	Research Site	Ocala	Florida	United States	34471
15	Research Site	Pembroke Pines	Florida	United States	33024
16	Research Site	Ponte Vedra	Florida	United States	32081
17	Research Site	Tampa	Florida	United States	33624
18	Research Site	Sandy Springs	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	New York	New York	United States	10016
26	Research Site	Cary	North Carolina	United States	27518
27	Research Site	Charlotte	North Carolina	United States	28207
28	Research Site	Charlotte	North Carolina	United States	28209
29	Research Site	Harrisburg	North Carolina	United States	28075
30	Research Site	Hickory	North Carolina	United States	28601
31	Research Site	Raleigh	North Carolina	United States	27609
32	Research Site	Salisbury	North Carolina	United States	28144
33	Research Site	Wilmington	North Carolina	United States	28401
34	Research Site	Winston-Salem	North Carolina	United States	27103
35	Research Site	Cleveland	Ohio	United States	44122
36	Research Site	Bala Cynwyd	Pennsylvania	United States	19004
37	Research Site	Lancaster	Pennsylvania	United States	17601
38	Research Site	El Paso	Texas	United States	79935
39	Research Site	Houston	Texas	United States	77074
40	Research Site	Spring	Texas	United States	77386

Sponsors and Collaborators

• VIVUS LLC

Investigators

• Principal Investigator: Andrew McCullough, MD, NYU Urology Associates

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: VIVUS LLC
• ClinicalTrials.gov Identifier: NCT00853606
• Other Study ID Numbers: TA-314
• First Posted: Mar 2, 2009
• Last Update Posted: Aug 17, 2012
• Last Verified: Aug 1, 2012

• Keywords provided by VIVUS LLC: ED; Erectile Dysfunction; Dysfunction; Erectile
• Additional relevant MeSH terms: Erectile Dysfunction

Study Results

Participant Flow

Recruitment Details	Subject recruitment occurred at US investigative sites between March 2009 and April 2010.

Arm/Group Title	Avanafil
Arm/Group Description	All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with the 100 mg dose may request a dose reduction to 50 mg. Study medication should be taken orally with water 30 minutes prior to the initiation of sexual activity.
Period Title: Overall Study
STARTED	712
COMPLETED	492
NOT COMPLETED	220

Baseline Characteristics

Arm/Group Title	Avanafil
Arm/Group Description	All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with the 100 mg dose may request a dose reduction to 50 mg. Study medication should be taken orally with water 30 minutes prior to the initiation of sexual activity.
Overall Participants	712
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.4 (10.19)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	712 100%
Region of Enrollment (participants) [Number]
United States	712 100%

Outcome Measures

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.
Description	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.
Time Frame	Baseline, 52 weeks

Outcome Measure Data

Analysis Population Description

Number of participants analyzed represents the Intent-to-Treat population.

Arm/Group Title	Avanafil
Arm/Group Description	All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with the 100 mg dose may request a dose reduction to 50 mg. Study medication should be taken orally with water 30 minutes prior to the initiation of sexual activity.
Measure Participants	686
Mean (Standard Deviation) [percentage of sexual attempts]	54.75 (35.915)

2. Primary Outcome

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 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.
Time Frame	Baseline, 52 weeks

Outcome Measure Data

Analysis Population Description

Number of participants analyzed represents to Intent-to-Treat population.

Arm/Group Title	Avanafil
Arm/Group Description	All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with the 100 mg dose may request a dose reduction to 50 mg. Study medication should be taken orally with water 30 minutes prior to the initiation of sexual activity.
Measure Participants	686
Mean (Standard Deviation) [percentage of sexual attempts]	36.91 (36.142)

3. Primary Outcome

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. 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.
Time Frame	Baseline, End of Treatment

Outcome Measure Data

Analysis Population Description

Number of participants analyzed represents the Intent-to-Treat population. For dropouts of missing data, the last observation carried forward convention was used.

Arm/Group Title	Avanafil
Arm/Group Description	All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with the 100 mg dose may request a dose reduction to 50 mg. Study medication should be taken orally with water 30 minutes prior to the initiation of sexual activity.
Measure Participants	686
Mean (Standard Deviation) [scores on a scale]	10.3 (7.88)

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 received at least one dose of avanafil during TA-314 and who have any safety data.
Arm/Group Title	Avanafil
Arm/Group Description	All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with the 100 mg dose may request a dose reduction to 50 mg. Study medication should be taken orally with water 30 minutes prior to the initiation of sexual activity.
All Cause Mortality
	Avanafil
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Avanafil
	Affected / at Risk (%)	# Events
Total	11/712 (1.5%)
Cardiac disorders
coronary artery disease	1/712 (0.1%)
atrial fibrillation	1/712 (0.1%)
aortic valve stenosis	1/712 (0.1%)
cardiac failure congestive	1/712 (0.1%)
Gastrointestinal disorders
pancreatitis acute	1/712 (0.1%)
inguinal hernia	1/712 (0.1%)
small intestinal obstruction	1/712 (0.1%)
Injury, poisoning and procedural complications
subdural hematoma	1/712 (0.1%)
cervical vertebral fracture	1/712 (0.1%)
Musculoskeletal and connective tissue disorders
cervical spinal stenosis	1/712 (0.1%)
Nervous system disorders
syncope vasovagal	1/712 (0.1%)
Psychiatric disorders
Acute physchosis	1/712 (0.1%)
Respiratory, thoracic and mediastinal disorders
pneumothorax	1/712 (0.1%)
Vascular disorders
femoral artery occlusion	1/712 (0.1%)
Other (Not Including Serious) Adverse Events
	Avanafil
	Affected / at Risk (%)	# Events
Total	87/712 (12.2%)
Infections and infestations
nasopharyngitis	24/712 (3.4%)
Nervous system disorders
headache	40/712 (5.6%)
Respiratory, thoracic and mediastinal disorders
nasal congestion	15/712 (2.1%)
Vascular disorders
flushing	25/712 (3.5%)

Limitations/Caveats

[Not Specified]

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.