Trial Outcomes & Findings for Research Evaluating an Investigational Medication for Erectile Dysfunction - Post-Prostatectomy (NCT NCT00895011)

NCT ID: NCT00895011

Last Updated: 2012-10-01

Results Overview

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?"

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 298 participants
• Primary outcome timeframe: Baseline, Week 12
• Results posted on: 2012-10-01

Participant Flow

Subject recruitment occurred at US investigative sites between April 2009 and December 2010.

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.

Participant milestones

Measure	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
Overall Study STARTED	100	99	99
Overall Study COMPLETED	76	85	91
Overall Study NOT COMPLETED	24	14	8

Reasons for withdrawal

Measure	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
Overall Study Withdrawal by Subject	14	7	2
Overall Study Lost to Follow-up	5	4	1
Overall Study Protocol Violation	3	1	3
Overall Study Adverse Event	1	2	2
Overall Study schedule conflict	1	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Placebo n=100 Participants	Avanafil 100 mg n=99 Participants	Avanafil 200 mg n=99 Participants	Total n=298 Participants Total of all reporting groups
Region of Enrollment United States	100 participants n=5 Participants	99 participants n=7 Participants	99 participants n=5 Participants	298 participants n=4 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	85 Participants n=5 Participants	81 Participants n=7 Participants	84 Participants n=5 Participants	250 Participants n=4 Participants
Age, Categorical >=65 years	15 Participants n=5 Participants	18 Participants n=7 Participants	15 Participants n=5 Participants	48 Participants n=4 Participants
Age Continuous	58.6 years STANDARD_DEVIATION 5.87 • n=5 Participants	58.9 years STANDARD_DEVIATION 5.88 • n=7 Participants	57.7 years STANDARD_DEVIATION 6.60 • n=5 Participants	58.4 years STANDARD_DEVIATION 6.13 • n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Male	100 Participants n=5 Participants	99 Participants n=7 Participants	99 Participants n=5 Participants	298 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

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

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?"

Outcome measures

Measure	Placebo n=96 Participants placeb 30 minutes orally prior to initiation of sexual activity	Avanafil 100 mg n=94 Participants avanafil 100 mg 30 minutes orally prior to initiation of sexual activity	Avanafil 200 mg n=96 Participants avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
Change in Percentage of Sexual Attempts in Which Subjects Are Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse	13.9 percentage of sexual attempts Standard Error 3.42	28.0 percentage of sexual attempts Standard Error 3.54	29.4 percentage of sexual attempts Standard Error 3.33

PRIMARY outcome

Timeframe: Baseline, Week 12

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

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?"

Outcome measures

Measure	Placebo n=96 Participants placeb 30 minutes orally prior to initiation of sexual activity	Avanafil 100 mg n=94 Participants avanafil 100 mg 30 minutes orally prior to initiation of sexual activity	Avanafil 200 mg n=96 Participants avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
The Change in Percentage of Sexual Attempts in Which Subjects Are Able to Insert the Penis Into the Partner's Vagina	7.5 Percentage of Sexual Attempts Standard Deviation 3.68	22.3 Percentage of Sexual Attempts Standard Deviation 3.66	27.7 Percentage of Sexual Attempts Standard Deviation 3.48

PRIMARY outcome

Timeframe: Baseline, End of Treatment (up to 12 weeks)

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

Questionnaire assesses subject's evaluation of erectile function over the previous 4-week period. Total scores from questions 1-5 & 15 range from 1 to 30. A higher score indicates better erectile function.

Outcome measures

Measure	Placebo n=95 Participants placeb 30 minutes orally prior to initiation of sexual activity	Avanafil 100 mg n=94 Participants avanafil 100 mg 30 minutes orally prior to initiation of sexual activity	Avanafil 200 mg n=96 Participants avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score	1.2 scores on a scale Standard Error 1.16	4.7 scores on a scale Standard Error 1.18	6.2 scores on a scale Standard Error 1.11

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Avanafil 100 mg

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Avanafil 200 mg

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=100 participants at risk	Avanafil 100 mg n=99 participants at risk	Avanafil 200 mg n=99 participants at risk
Infections and infestations Nasopharyngitis	0.00% 0/100 • 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. A treatment-emergent adverse event (TEAE) is an adverse event occurring on or after the first dose of study medication, or on or after the first dispensed date if missing, and prior to the last visit.	3.0% 3/99 • Number of events 3 • 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. A treatment-emergent adverse event (TEAE) is an adverse event occurring on or after the first dose of study medication, or on or after the first dispensed date if missing, and prior to the last visit.	5.1% 5/99 • Number of events 5 • 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. A treatment-emergent adverse event (TEAE) is an adverse event occurring on or after the first dose of study medication, or on or after the first dispensed date if missing, and prior to the last visit.
Nervous system disorders Headache	1.0% 1/100 • Number of events 1 • 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. A treatment-emergent adverse event (TEAE) is an adverse event occurring on or after the first dose of study medication, or on or after the first dispensed date if missing, and prior to the last visit.	8.1% 8/99 • Number of events 19 • 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. A treatment-emergent adverse event (TEAE) is an adverse event occurring on or after the first dose of study medication, or on or after the first dispensed date if missing, and prior to the last visit.	12.1% 12/99 • Number of events 35 • 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. A treatment-emergent adverse event (TEAE) is an adverse event occurring on or after the first dose of study medication, or on or after the first dispensed date if missing, and prior to the last visit.
Vascular disorders Flushing	0.00% 0/100 • 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. A treatment-emergent adverse event (TEAE) is an adverse event occurring on or after the first dose of study medication, or on or after the first dispensed date if missing, and prior to the last visit.	5.1% 5/99 • Number of events 30 • 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. A treatment-emergent adverse event (TEAE) is an adverse event occurring on or after the first dose of study medication, or on or after the first dispensed date if missing, and prior to the last visit.	10.1% 10/99 • Number of events 31 • 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. A treatment-emergent adverse event (TEAE) is an adverse event occurring on or after the first dose of study medication, or on or after the first dispensed date if missing, and prior to the last visit.

Additional Information

Wesley W Day, PhD

Vivus, Inc.

Phone: 650-934-5200

Email: medaffairs@vivus.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER