Trial · NCT00790751

Research Evaluating an Investigational Medication for Erectile Dysfunction - General ED

NCT00790751, Phase 3, Completed, VIVUS LLC; results first posted 2012-06-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Research Evaluating an Investigational Medication for Erectile Dysfunction - General ED. Trials, record NCT00790751. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00790751

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Research Evaluating an Investigational Medication for Erectile Dysfunction - General ED
NCT number: NCT00790751
Status: Completed
Phases: Phase 3
Enrollment: 646 participants, actual
Lead sponsor: VIVUS LLC
Conditions: Erectile Dysfunction
Interventions: placebo, avanafil, avanafil, avanafil
First posted: 2008-11-13
Last updated: 2012-07-11
Results first posted: 2012-06-28

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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?"
Primary	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?"
Primary	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.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	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	Number of participants analyzed represents the Intent-to-Treat population.	percentage of sexual attempts	LEAST_SQUARES_MEAN
PRIMARY	Change in Percentage of Sexual Attempts in Which Subjects Were Able to Insert the Penis Into the Partner's Vagina	Baseline, 12 weeks	Number of participants analyzed represents the Intent-to-Treat population.	percentage of sexual attempts	LEAST_SQUARES_MEAN
PRIMARY	Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score	Baseline, End of Treatment (up to 12 weeks)	Number of participants analyzed represents the Intent-to-Treat population. For dropouts or missing data, the last observation carried forward convention was used.	scores on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Percentage of Sexual Attempts in Which Subjects Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse	Placebo	14.1	Standard Error 2.57	percentage of sexual attempts
Change in Percentage of Sexual Attempts in Which Subjects Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse	Avanafil 50 mg	27.8	Standard Error 2.58	percentage of sexual attempts
Change in Percentage of Sexual Attempts in Which Subjects Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse	Avanafil 100 mg	43.4	Standard Error 2.56	percentage of sexual attempts
Change in Percentage of Sexual Attempts in Which Subjects Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse	Avanafil 200 mg	44.2	Standard Error 2.57	percentage of sexual attempts
Change in Percentage of Sexual Attempts in Which Subjects Were Able to Insert the Penis Into the Partner's Vagina	Placebo	7.1	Standard Error 2.33	percentage of sexual attempts
Change in Percentage of Sexual Attempts in Which Subjects Were Able to Insert the Penis Into the Partner's Vagina	Avanafil 50 mg	18.2	Standard Error 2.34	percentage of sexual attempts
Change in Percentage of Sexual Attempts in Which Subjects Were Able to Insert the Penis Into the Partner's Vagina	Avanafil 100 mg	27.2	Standard Error 2.32	percentage of sexual attempts
Change in Percentage of Sexual Attempts in Which Subjects Were Able to Insert the Penis Into the Partner's Vagina	Avanafil 200 mg	29.8	Standard Error 2.33	percentage of sexual attempts
Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score	Placebo	2.9	Standard Error 0.57	scores on a scale
Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score	Avanafil 50 mg	5.4	Standard Error 0.57	scores on a scale

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	162
Overall Study	STARTED	Avanafil 50 mg	161
Overall Study	STARTED	Avanafil 100 mg	161
Overall Study	STARTED	Avanafil 200 mg	162
Overall Study	COMPLETED	Placebo	137
Overall Study	COMPLETED	Avanafil 50 mg	131
Overall Study	COMPLETED	Avanafil 100 mg	141
Overall Study	COMPLETED	Avanafil 200 mg	141
Overall Study	NOT COMPLETED	Placebo	25
Overall Study	NOT COMPLETED	Avanafil 50 mg	30

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events56

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Nasopharyngitis	Infections and infestations	Placebo	2	161
other	Nasopharyngitis	Infections and infestations	Avanafil 50 mg	1	160
other	Nasopharyngitis	Infections and infestations	Avanafil 100 mg	2	161
other	Nasopharyngitis	Infections and infestations	Avanafil 200 mg	6	162
other	Bronchitis	Infections and infestations	Placebo	1	161
other	Bronchitis	Infections and infestations	Avanafil 50 mg	3	160
other	Bronchitis	Infections and infestations	Avanafil 100 mg	1	161
other	Bronchitis	Infections and infestations	Avanafil 200 mg	4	162
other	Headache	Nervous system disorders	Placebo	2	161
other	Headache	Nervous system disorders	Avanafil 50 mg	7	160

1 to 10 of 56Source ClinicalTrials.gov

See all 56 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Avanafil 50 mg
Total, all-cause mortality	Avanafil 100 mg
Total, all-cause mortality	Avanafil 200 mg
Total, other adverse events	Placebo	7	161
Total, other adverse events	Avanafil 50 mg	16	160
Total, other adverse events	Avanafil 100 mg	28	161
Total, other adverse events	Avanafil 200 mg	31	162
Total, serious adverse events	Placebo	2	161
Total, serious adverse events	Avanafil 50 mg	1	160

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
22248153	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00790751

GET https://conductscience.org/api/trials/v1/NCT00790751/events?page=2

API reference For AI assistants