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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

712 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Erectile Dysfunction

Keywords

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ED Erectile Dysfunction Dysfunction Erectile

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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avanafil

Group Type EXPERIMENTAL

avanafil

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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TA-1790 Stendra

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew McCullough, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Urology Associates

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Belkoff LH, McCullough A, Goldstein I, Jones L, Bowden CH, DiDonato K, Trask B, Day WW. An open-label, long-term evaluation of the safety, efficacy and tolerability of avanafil in male patients with mild to severe erectile dysfunction. Int J Clin Pract. 2013 Apr;67(4):333-41. doi: 10.1111/ijcp.12065.

Reference Type DERIVED

PMID: 23521325 (View on PubMed)

Other Identifiers

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TA-314

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

avanafil

avanafil

Interventions

avanafil

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

VIVUS LLC

Responsible Party

Principal Investigators

Andrew McCullough, MD

Locations

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Countries

References

Other Identifiers

TA-314