Research Evaluating an Investigational Medication for Erectile Dysfunction - Post-Prostatectomy

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

VIVUS, Inc.

ClinicalTrials.gov Identifier:

NCT00895011

First received: May 5, 2009

Last updated: September 14, 2012

Last verified: September 2012

History of Changes

Results First Received: May 25, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Erectile Dysfunction
Interventions:	Drug: Placebo Drug: Avanafil

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subject recruitment occurred at US investigative sites between April 2009 and December 2010.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
Placebo	placebo 30 minutes orally prior to initiation of sexual activity
Avanafil 100 mg	avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
Avanafil 200 mg	avanafil 200 mg 30 minutes orally prior to initiation of sexual activity

Participant Flow: Overall Study

	Placebo	Avanafil 100 mg	Avanafil 200 mg
STARTED	100	99	99
COMPLETED	76	85	91
NOT COMPLETED	24	14	8
Withdrawal by Subject	14	7	2
Lost to Follow-up	5	4	1
Protocol Violation	3	1	3
Adverse Event	1	2	2
schedule conflict	1	0	0

Baseline Characteristics

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Reporting Groups

	Description
Placebo	No text entered.
Avanafil 100 mg	No text entered.
Avanafil 200 mg	No text entered.
Total	Total of all reporting groups

Baseline Measures

	Placebo	Avanafil 100 mg	Avanafil 200 mg	Total
Number of Participants [units: participants]	100	99	99	298
Age [units: participants]
<=18 years	0	0	0	0
Between 18 and 65 years	85	81	84	250
>=65 years	15	18	15	48
Age [units: years] Mean ± Standard Deviation	58.6 ± 5.87	58.9 ± 5.88	57.7 ± 6.60	58.4 ± 6.13
Gender [units: participants]
Female	0	0	0	0
Male	100	99	99	298
Region of Enrollment [units: participants]
United States	100	99	99	298

Outcome Measures

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1. Primary:

Change in Percentage of Sexual Attempts in Which Subjects Are Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse [ Time Frame: Baseline, Week 12 ]

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2. Primary:

The Change in Percentage of Sexual Attempts in Which Subjects Are Able to Insert the Penis Into the Partner's Vagina [ Time Frame: Baseline, Week 12 ]

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3. Primary:

Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score [ Time Frame: Baseline, End of Treatment (up to 12 weeks) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Wesley W Day, PhD
Organization: Vivus, Inc.
phone: 650-934-5200
e-mail: medaffairs@vivus.com

No publications provided

Responsible Party:	VIVUS, Inc.
ClinicalTrials.gov Identifier:	NCT00895011 History of Changes
Obsolete Identifiers:	NCT01171001
Other Study ID Numbers:	TA-303
Study First Received:	May 5, 2009
Results First Received:	May 25, 2012
Last Updated:	September 14, 2012
Health Authority:	United States: Food and Drug Administration

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