Trial Outcomes & Findings for A Multicenter, Open Label, To Evaluate The Efficacy And Satisfaction Of Patrex® In Men With Erectile Dysfunction. (NCT NCT00468650)

Results Overview

IIEF is a self-administered scale designed to assess erectile functioning: includes 15 questions on 5 relevant domains of male sexual function; one is erectile function (EF). IIEF-EF Domain: sum of scores for Questions 1, 2, 3, 4, 5 \& 15 from IIEF. Score range: 0 to 5 (Q1 to Q5), 1 to 5 (Q15); total 1 to 30. Higher score indicates better outcome.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

117 participants

Primary outcome timeframe

Week 6 LOCF

Results posted on

2021-02-18

Participant Flow

Eligible subjects had to have at least 2 attempts at sexual intercourse during the 2 week screening phase to begin the sildenafil citrate 50mg treatment at baseline.

Participant milestones

Participant milestones
Measure	Open Label Sildenafil Citrate Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Overall Study STARTED	117
Overall Study COMPLETED	110
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Open Label Sildenafil Citrate Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Overall Study Lost to Follow-up	4
Overall Study Withdrawal by Subject	2
Overall Study Protocol Violation	1

Baseline Characteristics

A Multicenter, Open Label, To Evaluate The Efficacy And Satisfaction Of Patrex® In Men With Erectile Dysfunction.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open Label Sildenafil Citrate n=117 Participants Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Age, Continuous	53.3 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	117 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 6 LOCF

Population: Modified intent to treat (MITT) population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, last assessment collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

IIEF is a self-administered scale designed to assess erectile functioning: includes 15 questions on 5 relevant domains of male sexual function; one is erectile function (EF). IIEF-EF Domain: sum of scores for Questions 1, 2, 3, 4, 5 \& 15 from IIEF. Score range: 0 to 5 (Q1 to Q5), 1 to 5 (Q15); total 1 to 30. Higher score indicates better outcome.

Outcome measures

Outcome measures
Measure	Open Label Sildenafil Citrate n=113 Participants Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score- Change From Baseline to Week 6 Last Observation Carried Forward (LOCF)	10.96 score on scale Standard Deviation 5.19

SECONDARY outcome

Timeframe: Week 2, Week 4 and Week 6

Population: MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. Week 6 Endpoint = last observation recorded after Week 2

IIEF is a self-administered scale designed to assess erectile functioning: includes 15 questions on 5 relevant domains of male sexual function; one is erectile function (EF). IIEF-EF Domain: sum of scores for Questions 1, 2, 3, 4, 5 \& 15 from IIEF. Score range: 0 to 5 (Q1 to Q5), 1 to 5 (Q15); total 1 to 30. Higher score indicates better outcome.

Outcome measures

Outcome measures
Measure	Open Label Sildenafil Citrate n=113 Participants Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score - Change From Baseline at Weeks 2, 4 and 6 Week 2 (N=113)	7.14 score on a scale Standard Deviation 5.21
International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score - Change From Baseline at Weeks 2, 4 and 6 Week 4 (N=112)	10.57 score on a scale Standard Deviation 5.43
International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score - Change From Baseline at Weeks 2, 4 and 6 Week 6 (N=110)	10.93 score on a scale Standard Deviation 5.26
International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score - Change From Baseline at Weeks 2, 4 and 6 Week 6 Endpoint (N=112)	10.95 score on a scale Standard Deviation 5.21

SECONDARY outcome

Timeframe: Week 4 and Week 6

Population: MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

IIEF is a self-administered scale designed to assess erectile functioning: includes 15 questions on 5 relevant domains of male sexual function; one is erectile function (EF). IIEF-EF Domain: sum of scores for Questions 1, 2, 3, 4, 5 \& 15 from IIEF. Score range: 0 to 5 (Q1 to Q5), 1 to 5 (Q15); total 1 to 30. Higher score indicates better outcome.

Outcome measures

Outcome measures
Measure	Open Label Sildenafil Citrate n=112 Participants Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score- Change From Week 2 Week 4 (N=112)	3.48 score on scale Standard Deviation 3.97
International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score- Change From Week 2 Week 6 (N=110)	3.88 score on scale Standard Deviation 4.38
International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score- Change From Week 2 Week 6 LOCF (N=112)	3.86 score on scale Standard Deviation 4.35
International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score- Change From Week 2 Week 6 Endpoint (N=112)	3.86 score on scale Standard Deviation 4.35

SECONDARY outcome

Timeframe: Week 2, Week 4 and Week 6

Population: MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is orgasmic function. IIEF Orgasmic Function Domain was sum of scores for Questions 9 and 10 from the IIEF. Score range: 0 to 5; total 0 to 10. Higher score indicates better outcome.

Outcome measures

Outcome measures
Measure	Open Label Sildenafil Citrate n=113 Participants Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
International Index of Erectile Function (IIEF), Orgasmic Function Domain- Change From Baseline Week 4 (N=112)	2.46 score on scale Standard Deviation 2.32
International Index of Erectile Function (IIEF), Orgasmic Function Domain- Change From Baseline Week 2 (N=113)	1.89 score on scale Standard Deviation 2.40
International Index of Erectile Function (IIEF), Orgasmic Function Domain- Change From Baseline Week 6 (N=110)	2.59 score on scale Standard Deviation 2.44
International Index of Erectile Function (IIEF), Orgasmic Function Domain- Change From Baseline Week 6 LOCF (N=113)	2.63 score on scale Standard Deviation 2.45
International Index of Erectile Function (IIEF), Orgasmic Function Domain- Change From Baseline Week 6 Endpoint (N=112)	2.59 score on scale Standard Deviation 2.42

SECONDARY outcome

Timeframe: Week 4 and Week 6

Population: MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is orgasmic function. IIEF Orgasmic Function Domain was sum of scores for Questions 9 and 10 from the IIEF. Score range: 0 to 5; total 0 to 10. Higher score indicates better outcome.

Outcome measures

Outcome measures
Measure	Open Label Sildenafil Citrate n=112 Participants Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
International Index of Erectile Function (IIEF), Orgasmic Function Domain- Change From Week 2 Week 4 (N=112)	0.61 score on scale Standard Deviation 1.51
International Index of Erectile Function (IIEF), Orgasmic Function Domain- Change From Week 2 Week 6 (N=110)	0.75 score on scale Standard Deviation 1.46
International Index of Erectile Function (IIEF), Orgasmic Function Domain- Change From Week 2 Week 6 LOCF (N=112)	0.74 score on scale Standard Deviation 1.45
International Index of Erectile Function (IIEF), Orgasmic Function Domain- Change From Week 2 Week 6 Endpoint (N=112)	0.74 score on scale Standard Deviation 1.45

SECONDARY outcome

Timeframe: Week 2, Week 4 and Week 6

Population: MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one of which is sexual desire. IIEF Sexual Desire Domain was sum of scores for Questions 11 and 12 from the IIEF. Score range: 1 to 5; total 2 to 10. Higher score indicates better outcome.

Outcome measures

Outcome measures
Measure	Open Label Sildenafil Citrate n=113 Participants Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
International Index of Erectile Function (IIEF), Sexual Desire Domain Score- Change From Baseline Week 2 (N=113)	1.43 score on scale Standard Deviation 1.87
International Index of Erectile Function (IIEF), Sexual Desire Domain Score- Change From Baseline Week 4 (N=112)	2.00 score on scale Standard Deviation 1.86
International Index of Erectile Function (IIEF), Sexual Desire Domain Score- Change From Baseline Week 6 (N=110)	2.25 score on scale Standard Deviation 1.91
International Index of Erectile Function (IIEF), Sexual Desire Domain Score- Change From Baseline Week 6 LOCF (N=113)	2.26 score on scale Standard Deviation 1.94
International Index of Erectile Function (IIEF), Sexual Desire Domain Score- Change From Baseline Week 6 Endpoint (N=112)	2.28 score on scale Standard Deviation 1.93

SECONDARY outcome

Timeframe: Week 4 and Week 6

Population: MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one of which is sexual desire. IIEF Sexual Desire Domain was sum of scores for Questions 11 and 12 from the IIEF. Score range: 1 to 5; total 2 to 10. Higher score indicates better outcome.

Outcome measures

Outcome measures
Measure	Open Label Sildenafil Citrate n=112 Participants Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
International Index of Erectile Function (IIEF), Sexual Desire Domain Score- Change From Week 2 Week 4 (N=112)	0.55 score on scale Standard Deviation 1.41
International Index of Erectile Function (IIEF), Sexual Desire Domain Score- Change From Week 2 Week 6 (N=110)	0.81 score on scale Standard Deviation 1.47
International Index of Erectile Function (IIEF), Sexual Desire Domain Score- Change From Week 2 Week 6 LOCF (N=112)	0.83 score on scale Standard Deviation 1.49
International Index of Erectile Function (IIEF), Sexual Desire Domain Score- Change From Week 2 Week 6 Endpoint (N=112)	0.83 score on scale Standard Deviation 1.49

SECONDARY outcome

Timeframe: Week 2, Week 4, and Week 6

Population: MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is intercourse satisfaction. IIEF Intercourse Satisfaction Domain: sum of scores for Questions 6, 7 and 8 from IIEF. Score range: 0 to 5; total 0 to 15. Higher score indicates better outcome.

Outcome measures

Outcome measures
Measure	Open Label Sildenafil Citrate n=113 Participants Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain Score- Change From Baseline Week 2 (N=113)	3.18 score on scale Standard Deviation 2.42
International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain Score- Change From Baseline Week 4 (N=112)	4.38 score on scale Standard Deviation 2.39
International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain Score- Change From Baseline Week 6 (N=110)	4.73 score on scale Standard Deviation 2.53
International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain Score- Change From Baseline Week 6 LOCF (N=113)	4.70 score on scale Standard Deviation 2.52
International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain Score- Change From Baseline Week 6 Endpoint (N=112)	4.72 score on scale Standard Deviation 2.52

SECONDARY outcome

Timeframe: Week 4 and Week 6

Population: MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is intercourse satisfaction. IIEF Intercourse Satisfaction Domain: sum of scores for Questions 6, 7 and 8 from IIEF. Score range: 0 to 5; total 0 to 15. Higher score indicates better outcome.

Outcome measures

Outcome measures
Measure	Open Label Sildenafil Citrate n=112 Participants Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain Score- Change From Week 2 Week 4 (N=112)	1.20 score on scale Standard Deviation 2.10
International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain Score- Change From Week 2 Week 6 (N=110)	1.54 score on scale Standard Deviation 2.20
International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain Score- Change From Week 2 Week 6 LOCF (N=112)	1.54 score on scale Standard Deviation 2.19
International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain Score- Change From Week 2 Week 6 Endpoint (N=112)	1.54 score on scale Standard Deviation 2.19

SECONDARY outcome

Timeframe: Week 2, Week 4 and Week 6

Population: MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is overall satisfaction. IIEF Overall Satisfaction Domain was sum of scores for Questions 13 and 14 from the IIEF. Score range: 1 to 5; total 2 to 10. Higher score indicates better outcome.

Outcome measures

Outcome measures
Measure	Open Label Sildenafil Citrate n=113 Participants Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
International Index of Erectile Function (IIEF), Overall Satisfaction Domain Score- Change From Baseline Week 2 (N=113)	2.73 score on scale Standard Deviation 2.38
International Index of Erectile Function (IIEF), Overall Satisfaction Domain Score- Change From Baseline Week 4 (N=112)	3.67 score on scale Standard Deviation 2.49
International Index of Erectile Function (IIEF), Overall Satisfaction Domain Score- Change From Baseline Week 6 (N=110)	3.92 score on scale Standard Deviation 2.52
International Index of Erectile Function (IIEF), Overall Satisfaction Domain Score- Change From Baseline Week 6 LOCF (N=113)	3.91 score on scale Standard Deviation 2.53
International Index of Erectile Function (IIEF), Overall Satisfaction Domain Score- Change From Baseline Week 6 Endpoint (N=112)	3.89 score on scale Standard Deviation 2.53

SECONDARY outcome

Timeframe: Week 4 and Week 6

Population: MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is overall satisfaction. IIEF Overall Satisfaction Domain was sum of scores for Questions 13 and 14 from the IIEF. Score range: 1 to 5; total 2 to 10. Higher score indicates better outcome.

Outcome measures

Outcome measures
Measure	Open Label Sildenafil Citrate n=112 Participants Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
International Index of Erectile Function (IIEF), Overall Satisfaction Domain Score- Change From Week 2 Week 4 (N=112)	0.97 score on scale Standard Deviation 1.88
International Index of Erectile Function (IIEF), Overall Satisfaction Domain Score- Change From Week 2 Week 6 (N=110)	1.21 score on scale Standard Deviation 1.92
International Index of Erectile Function (IIEF), Overall Satisfaction Domain Score- Change From Week 2 Week 6 LOCF (N=112)	1.20 score on scale Standard Deviation 1.90
International Index of Erectile Function (IIEF), Overall Satisfaction Domain Score- Change From Week 2 Week 6 Endpoint (N=112)	1.20 score on scale Standard Deviation 1.90

SECONDARY outcome

Timeframe: Week 2, Week 4, and Week 6

Population: MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

QEQ is a self-administered scale used to assess erection hardness and overall quality of erections. The QEQ total score is defined as the sum of the scores from QEQ Questions 1-6. Score range: 1 to 5. Higher score indicates better outcome. Raw QEQ score ranges from 6-30 and is transformed onto a 0-100 scale.

Outcome measures

Outcome measures
Measure	Open Label Sildenafil Citrate n=113 Participants Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Quality of Erection Questionnaire (QEQ): Total Score - Change From Baseline Week 2 (N=113)	32.71 score on scale Standard Deviation 25.36
Quality of Erection Questionnaire (QEQ): Total Score - Change From Baseline Week 4 (N=112)	46.21 score on scale Standard Deviation 26.27
Quality of Erection Questionnaire (QEQ): Total Score - Change From Baseline Week 6 (N=110)	45.53 score on scale Standard Deviation 26.96
Quality of Erection Questionnaire (QEQ): Total Score - Change From Baseline Week 6 LOCF (N=113)	45.28 score on scale Standard Deviation 27.01
Quality of Erection Questionnaire (QEQ): Total Score - Change From Baseline Week 6 Endpoint (N=112)	45.05 score on scale Standard Deviation 27.02

SECONDARY outcome

Timeframe: Week 4 and Week 6

QEQ is a self-administered scale used to assess erection hardness and overall quality of erections. The QEQ total score is defined as the sum of the scores from QEQ Questions 1-6. Score range: 1 to 5. Higher score indicates better outcome. Raw QEQ score ranges from 6-30 and is transformed onto a 0-100 scale.

Outcome measures

Outcome measures
Measure	Open Label Sildenafil Citrate n=113 Participants Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Quality of Erection Questionnaire (QEQ): Total Score- Change From Week 2 Week 4 (N=112)	13.84 score on scale Standard Deviation 21.10
Quality of Erection Questionnaire (QEQ): Total Score- Change From Week 2 Week 6 (N=110)	13.07 score on scale Standard Deviation 24.25
Quality of Erection Questionnaire (QEQ): Total Score- Change From Week 2 Week 6 LOCF (N=112)	12.69 score on scale Standard Deviation 24.26
Quality of Erection Questionnaire (QEQ): Total Score- Change From Week 2 Week 6 Endpoint (N=112)	12.69 score on scale Standard Deviation 24.26

SECONDARY outcome

Timeframe: Week 2, Week 4 and Week 6

Population: MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions. Sex-Q Erection domain: sum of scores for Questions 1, 2, 3, 4, 5 and 6 from the Sex-Q. Score range: 1 to 5; total 6 to 30. Higher score indicates better outcome.

Outcome measures

Outcome measures
Measure	Open Label Sildenafil Citrate n=113 Participants Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Sexual Experience Questionnaire (Sex-Q): Erection Domain - Change From Baseline Week 2 (N=113)	5.41 score on scale Standard Deviation 4.40
Sexual Experience Questionnaire (Sex-Q): Erection Domain - Change From Baseline Week 4 (N=112)	8.85 score on scale Standard Deviation 4.96
Sexual Experience Questionnaire (Sex-Q): Erection Domain - Change From Baseline Week 6 (N=110)	9.21 score on scale Standard Deviation 5.19
Sexual Experience Questionnaire (Sex-Q): Erection Domain - Change From Baseline Week 6 LOCF (N=113)	9.28 score on scale Standard Deviation 5.14
Sexual Experience Questionnaire (Sex-Q): Erection Domain - Change From Baseline Week 6 Endpoint (N=112)	9.25 score on scale Standard Deviation 5.15

SECONDARY outcome

Timeframe: Week 4 and Week 6

Population: MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions. Sex-Q Erection domain: sum of scores for Questions 1, 2, 3, 4, 5 and 6 from the Sex-Q. Score range: 1 to 5; total 6 to 30. Higher score indicates better outcome.

Outcome measures

Outcome measures
Measure	Open Label Sildenafil Citrate n=112 Participants Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Sexual Experience Questionnaire (Sex-Q): Erection Domain- Change From Week 2 Week 4 (N=112)	3.51 score on scale Standard Deviation 3.89
Sexual Experience Questionnaire (Sex-Q): Erection Domain- Change From Week 2 Week 6 (N=110)	3.91 score on scale Standard Deviation 4.41
Sexual Experience Questionnaire (Sex-Q): Erection Domain- Change From Week 2 Week 6 LOCF (N=112)	3.91 score on scale Standard Deviation 4.38
Sexual Experience Questionnaire (Sex-Q): Erection Domain- Change From Week 2 Week 6 Endpoint (N=112)	3.91 score on scale Standard Deviation 4.38

SECONDARY outcome

Timeframe: Week 2, Week 4, and Week 6

Population: MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions (q). Sex-Q Satisfaction domain:sum of scores for q 10, 11, 12, 13, 14 and 15 from Sex-Q. Score range:1 to 5; total 6 to 30. Higher score indicates better outcome

Outcome measures

Outcome measures
Measure	Open Label Sildenafil Citrate n=113 Participants Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Sexual Experience Questionnaire (Sex-Q): Satisfaction Domain - Change From Baseline Week 2 (N=113)	6.68 score on scale Standard Deviation 4.86
Sexual Experience Questionnaire (Sex-Q): Satisfaction Domain - Change From Baseline Week 4 (N=112)	9.94 score on scale Standard Deviation 5.21
Sexual Experience Questionnaire (Sex-Q): Satisfaction Domain - Change From Baseline Week 6 (N=108)	10.59 score on scale Standard Deviation 5.08
Sexual Experience Questionnaire (Sex-Q): Satisfaction Domain - Change From Baseline Week 6 LOCF (N=111)	10.63 score on scale Standard Deviation 5.03
Sexual Experience Questionnaire (Sex-Q): Satisfaction Domain - Change From Baseline Week 6 Endpoint (N=110)	10.64 score on scale Standard Deviation 5.06

SECONDARY outcome

Timeframe: Week 4 and Week 6

Population: MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions (q). Sex-Q Satisfaction domain:sum of scores for q 10, 11, 12, 13, 14 and 15 from Sex-Q. Score range:1 to 5; total 6 to 30. Higher score indicates better outcome

Outcome measures

Outcome measures
Measure	Open Label Sildenafil Citrate n=112 Participants Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Sexual Experience Questionnaire (Sex-Q): Satisfaction Domain - Change From Week 2 Week 6 LOCF (N=110)	4.01 score on scale Standard Deviation 5.04
Sexual Experience Questionnaire (Sex-Q): Satisfaction Domain - Change From Week 2 Week 4 (N=112)	3.29 score on scale Standard Deviation 4.10
Sexual Experience Questionnaire (Sex-Q): Satisfaction Domain - Change From Week 2 Week 6 (N=108)	4.03 score on scale Standard Deviation 5.09
Sexual Experience Questionnaire (Sex-Q): Satisfaction Domain - Change From Week 2 Week 6 Endpoint (N=110)	4.01 score on scale Standard Deviation 5.04

SECONDARY outcome

Timeframe: Week 2, Week 4, and Week 6

Population: MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions. Sex-Q Relationship domain was sum of scores for Questions 7, 8 and 9 from the Sex-Q. Score range: 1 to 5; total 3 to 15. Higher score indicates better outcome.

Outcome measures

Outcome measures
Measure	Open Label Sildenafil Citrate n=112 Participants Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Sexual Experience Questionnaire (Sex-Q): Relationship Domain - Change From Baseline Week 2 (N=112)	2.79 score on scale Standard Deviation 2.44
Sexual Experience Questionnaire (Sex-Q): Relationship Domain - Change From Baseline Week 4 (N=111)	4.23 score on scale Standard Deviation 2.56
Sexual Experience Questionnaire (Sex-Q): Relationship Domain - Change From Baseline Week 6 (N=108)	4.74 score on scale Standard Deviation 2.84
Sexual Experience Questionnaire (Sex-Q): Relationship Domain - Change From Baseline Week 6 LOCF (N=111)	4.78 score on scale Standard Deviation 2.81
Sexual Experience Questionnaire (Sex-Q): Relationship Domain - Change From Baseline Week 6 Endpoint (N=110)	4.76 score on scale Standard Deviation 2.82

SECONDARY outcome

Timeframe: Week 4 and Week 6

Population: MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions. Sex-Q Relationship domain was sum of scores for Questions 7, 8 and 9 from the Sex-Q. Score range: 1 to 5; total 3 to 15. Higher score indicates better outcome.

Outcome measures

Outcome measures
Measure	Open Label Sildenafil Citrate n=112 Participants Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Sexual Experience Questionnaire (Sex-Q): Relationship Domain - Change From Week 2 Week 4 (N=112)	1.49 score on scale Standard Deviation 1.91
Sexual Experience Questionnaire (Sex-Q): Relationship Domain - Change From Week 2 Week 6 (N=109)	1.96 score on scale Standard Deviation 2.08
Sexual Experience Questionnaire (Sex-Q): Relationship Domain - Change From Week 2 Week 6 LOCF (N=111)	1.98 score on scale Standard Deviation 2.07
Sexual Experience Questionnaire (Sex-Q): Relationship Domain - Change From Week 2 Week 6 Endpoint (N=111)	1.98 score on scale Standard Deviation 2.07

SECONDARY outcome

Timeframe: Week 2, Week 4 and Week 6

Population: MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Mean change: mean change at each visit minus mean at baseline. Percent of "Yes" responses to Question 1 based on occasions (= sexual stimulation): 100\*(number of occasions where SEP Question 1 \[Were you able to achieve at least some erection (some enlargement of the penis)?\] = Yes) / (number of occasions where Question 1 was answered Yes or No)

Outcome measures

Outcome measures
Measure	Open Label Sildenafil Citrate n=110 Participants Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 1 on Occasions With Sexual Stimulation- Change From Baseline Question 1 (Week 2) N=110	8.84 per-patient percentage Standard Deviation 28.70
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 1 on Occasions With Sexual Stimulation- Change From Baseline Question 1 (Week 4) N=108	10.18 per-patient percentage Standard Deviation 27.51
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 1 on Occasions With Sexual Stimulation- Change From Baseline Question 1 (Week 6) N=105	12.29 per-patient percentage Standard Deviation 28.88
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 1 on Occasions With Sexual Stimulation- Change From Baseline Question 1 (Week 6 LOCF) N=110	11.96 per-patient percentage Standard Deviation 28.33
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 1 on Occasions With Sexual Stimulation- Change From Baseline Question 1 (Week 6 Endpoint) N=108	11.95 per-patient percentage Standard Deviation 28.55

SECONDARY outcome

Timeframe: Week 4 and Week 6

Population: MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Mean change: mean change at each visit minus mean at Week 2. Percent of "Yes" responses to Question 1 based on occasions (= sexual stimulation): 100\*(number of occasions where SEP Question 1 \[Were you able to achieve at least some erection (some enlargement of the penis)?\] = Yes) / (number of occasions where Question 1 was answered Yes or No)

Outcome measures

Outcome measures
Measure	Open Label Sildenafil Citrate n=113 Participants Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 1 Based on Occasions With Sexual Stimulation- Change From Week 2 Question 1 (Week 4) N=111	1.37 per-patient percentage Standard Deviation 14.85
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 1 Based on Occasions With Sexual Stimulation- Change From Week 2 Question 1 (Week 6) N=108	3.12 per-patient percentage Standard Deviation 14.26
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 1 Based on Occasions With Sexual Stimulation- Change From Week 2 Question 1 (Week 6 LOCF) N=113	2.98 per-patient percentage Standard Deviation 13.95
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 1 Based on Occasions With Sexual Stimulation- Change From Week 2 Question 1 (Week 6 Endpoint) N=111	3.04 per-patient percentage Standard Deviation 14.07

SECONDARY outcome

Timeframe: Week 2, Week 4 and Week 6

Population: MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Mean change: mean change at each visit minus mean at baseline. Percent of "Yes" responses to SEP Question 2 based on occasions (= sexual stimulation): 100\*(number of occasions where SEP Question 2 \["Were you able to insert your penis into your partner's vagina?"\] = "Yes") / (number of occasions where SEP Question 2 was answered "Yes" or "No").

Outcome measures

Outcome measures
Measure	Open Label Sildenafil Citrate n=102 Participants Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 2 on Occasions With Sexual Stimulation- Change From Baseline Question 2 (Week 2) N=102	15.37 per-patient percentage Standard Deviation 30.51
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 2 on Occasions With Sexual Stimulation- Change From Baseline Question 2 (Week 4) N=100	17.15 per-patient percentage Standard Deviation 32.22
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 2 on Occasions With Sexual Stimulation- Change From Baseline Question 2 (Week 6) N=97	18.22 per-patient percentage Standard Deviation 32.44
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 2 on Occasions With Sexual Stimulation- Change From Baseline Question 2 (Week 6 LOCF) N=102	17.33 per-patient percentage Standard Deviation 31.87
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 2 on Occasions With Sexual Stimulation- Change From Baseline Question 2 (Week 6 Endpoint) N=100	17.68 per-patient percentage Standard Deviation 32.10

SECONDARY outcome

Timeframe: Week 4 and Week 6

Population: MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Mean change: mean change at each visit minus mean at Week 2. Percent of "Yes" responses to SEP Question 2 based on occasions (= sexual stimulation): 100\*(number of occasions where SEP Question 2 \["Were you able to insert your penis into your partner's vagina?"\] = "Yes") / (number of occasions where SEP Question 2 was answered "Yes" or "No").

Outcome measures

Outcome measures
Measure	Open Label Sildenafil Citrate n=112 Participants Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 2 on Occasions With Sexual Stimulation- Change From Week 2 Question 2 (Week 4) N=110	1.46 per-patient percentage Standard Deviation 9.41
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 2 on Occasions With Sexual Stimulation- Change From Week 2 Question 2 (Week 6) N=107	1.18 per-patient percentage Standard Deviation 12.33
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 2 on Occasions With Sexual Stimulation- Change From Week 2 Question 2 (Week 6 LOCF) N=112	1.13 per-patient percentage Standard Deviation 12.05
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 2 on Occasions With Sexual Stimulation- Change From Week 2 Question 2 (Week 6 Endpoint) N=110	1.15 per-patient percentage Standard Deviation 12.16

SECONDARY outcome

Timeframe: Week 2, Week 4 and Week 6

Population: MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

Mean change: mean change at each visit minus mean at baseline. Percent of "Yes" responses to SEP Question 2 based on occasions (= sexual stimulation): 100\*(number of occasions where SEP Question 3 \[Did your erection last long enough for you to have successful intercourse?\] = Yes) / (number of occasions where SEP Question 3 was answered Yes or No)

Outcome measures

Outcome measures
Measure	Open Label Sildenafil Citrate n=102 Participants Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 on Occasions With Sexual Stimulation- Change From Baseline Question 3 (Week 2) N=102	56.96 per-patient percentage Standard Deviation 38.93
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 on Occasions With Sexual Stimulation- Change From Baseline Question 3 (Week 4) N=100	70.78 per-patient percentage Standard Deviation 35.46
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 on Occasions With Sexual Stimulation- Change From Baseline Question 3 (Week 6) N=97	71.23 per-patient percentage Standard Deviation 35.79
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 on Occasions With Sexual Stimulation- Change From Baseline Question 3 (Week 6 LOCF) N=102	72.15 per-patient percentage Standard Deviation 35.41
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 on Occasions With Sexual Stimulation- Change From Baseline Question 3 (Week 6 Endpoint) N=100	71.60 per-patient percentage Standard Deviation 35.55

SECONDARY outcome

Timeframe: Week 4 and Week 6

Population: MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Mean change: mean change at each visit minus mean at Week 2. Percent of "Yes" responses to SEP Question 2 based on occasions (= sexual stimulation): 100\*(number of occasions where SEP Question 3 \[Did your erection last long enough for you to have successful intercourse?\] = Yes) / (number of occasions where SEP Question 3 was answered Yes or No)

Outcome measures

Outcome measures
Measure	Open Label Sildenafil Citrate n=112 Participants Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 Based on Occasions With Sexual Stimulation- Change From Week 2 Question 3 (Week 4) N=110	13.56 per-patient percentage Standard Deviation 30.89
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 Based on Occasions With Sexual Stimulation- Change From Week 2 Question 3 (Week 6) N=107	14.25 per-patient percentage Standard Deviation 31.31
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 Based on Occasions With Sexual Stimulation- Change From Week 2 Question 3 (Week 6 LOCF) N=112	14.51 per-patient percentage Standard Deviation 31.77
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 Based on Occasions With Sexual Stimulation- Change From Week 2 Question 3 (Week 6 Endpoint) N=110	14.77 per-patient percentage Standard Deviation 32.00

SECONDARY outcome

Timeframe: Week 2, Week 4 and Week 6

Population: MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Mean change: mean change at each visit minus mean at baseline. Percent of "Yes" responses to SEP Question 4 based on occasions (= sexual stimulation): 100\*(number of occasions where SEP Question 4 \["Were you satisfied with the hardness of your erection?"\] = "Yes") / (number of occasions where SEP Question 4 was answered "Yes" or "No").

Outcome measures

Outcome measures
Measure	Open Label Sildenafil Citrate n=102 Participants Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 4 Based on Occasions With Sexual Stimulation- Change From Baseline Question 4 (Week 2) N=102	58.58 per-patient percentage Standard Deviation 41.24
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 4 Based on Occasions With Sexual Stimulation- Change From Baseline Question 4 (Week 4) N=100	76.29 per-patient percentage Standard Deviation 37.21
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 4 Based on Occasions With Sexual Stimulation- Change From Baseline Question 4(Week 6) N=97	77.69 per-patient percentage Standard Deviation 37.26
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 4 Based on Occasions With Sexual Stimulation- Change From Baseline Question 4 (Week 6 LOCF) N=102	78.79 per-patient percentage Standard Deviation 36.65
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 4 Based on Occasions With Sexual Stimulation- Change From Baseline Question 4 (Week 6 Endpoint) N=100	78.36 per-patient percentage Standard Deviation 36.89

SECONDARY outcome

Timeframe: Week 4 and Week 6

Population: MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Mean change: mean change at each visit minus mean at Week 2. Percent of "Yes" responses to SEP Question 4 based on occasions (= sexual stimulation): 100\*(number of occasions where SEP Question 4 \["Were you satisfied with the hardness of your erection?"\] = "Yes") / (number of occasions where SEP Question 4 was answered "Yes" or "No").

Outcome measures

Outcome measures
Measure	Open Label Sildenafil Citrate n=112 Participants Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 4 Based on Occasions With Sexual Stimulation- Change From Week 2 Question 4 (Week 4) N=110	17.90 per-patient percentage Standard Deviation 36.63
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 4 Based on Occasions With Sexual Stimulation- Change From Week 2 Question 4 (Week 6) N=107	19.50 per-patient percentage Standard Deviation 36.84
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 4 Based on Occasions With Sexual Stimulation- Change From Week 2 Question 4 (Week 6 LOCF) N=112	19.52 per-patient percentage Standard Deviation 36.99
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 4 Based on Occasions With Sexual Stimulation- Change From Week 2 Question 4 (Week 6 Endpoint) N=110	19.88 per-patient percentage Standard Deviation 37.23

SECONDARY outcome

Timeframe: Week 2, Week 4 and Week 6

Population: MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

Mean change: mean change at each visit minus mean at baseline. Percent of "Yes" responses to SEP Question 5 based on occasions (= sexual stimulation): 100\*(number of occasions where SEP Question 5 \["Were you satisfied with this sexual encounter?"\] = "Yes") / (number of occasions where SEP Question 5 was answered "Yes" or "No")

Outcome measures

Outcome measures
Measure	Open Label Sildenafil Citrate n=102 Participants Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 5 Based on Occasions With Sexual Stimulation- Change From Baseline Question 5 (Week 2) N=101	57.34 per-patient percentage Standard Deviation 42.60
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 5 Based on Occasions With Sexual Stimulation- Change From Baseline Question 5 (Week 4) N=100	70.72 per-patient percentage Standard Deviation 40.30
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 5 Based on Occasions With Sexual Stimulation- Change From Baseline Question 5 (Week 6) N=97	70.63 per-patient percentage Standard Deviation 40.78
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 5 Based on Occasions With Sexual Stimulation- Change From Baseline Question 5 (Week 6 LOCF) N=102	72.07 per-patient percentage Standard Deviation 40.27
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 5 Based on Occasions With Sexual Stimulation- Change From Baseline Question 5 (Week 6 Endpoint) N=100	71.51 per-patient percentage Standard Deviation 40.48

SECONDARY outcome

Timeframe: Week 4 and Week 6

Population: MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Mean change: mean change at each visit minus mean at Week 2. Percent of "Yes" responses to SEP Question 5 based on occasions (= sexual stimulation): 100\*(number of occasions where SEP Question 5 \["Were you satisfied with this sexual encounter?"\] = "Yes") / (number of occasions where SEP Question 5 was answered "Yes" or "No")

Outcome measures

Outcome measures
Measure	Open Label Sildenafil Citrate n=111 Participants Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 5 Based on Occasions With Sexual Stimulation- Change From Week 2 Question 5 (Week 4) N=109	13.10 per-patient percentage Standard Deviation 29.11
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 5 Based on Occasions With Sexual Stimulation- Change From Week 2 Question 5 (Week 6) N=106	14.11 per-patient percentage Standard Deviation 32.53
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 5 Based on Occasions With Sexual Stimulation- Change From Week 2 Question 5 (Week 6 LOCF) N=111	13.47 per-patient percentage Standard Deviation 31.92
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 5 Based on Occasions With Sexual Stimulation- Change From Week 2 Question 5 (Week 6 Endpoint) N=109	13.72 per-patient percentage Standard Deviation 32.16

SECONDARY outcome

Timeframe: Week 2, Week 4, and Week 6

Population: MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Mean change: mean change at each visit minus mean at baseline. Percent of "Yes" responses to SEP Q3 based on attempts with sexual stimulation (SS): 100\* (number of attempts with SS where SEP Q3 \[Did your erection last long enough for you to have successful intercourse?\] = Yes)/(number of attempts with SS where SEP Q3 was answered Yes or No)

Outcome measures

Outcome measures
Measure	Open Label Sildenafil Citrate n=102 Participants Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 (Q3) Based on Attempts With Sexual Stimulation- Change From Baseline Week 2 (N=102)	56.96 per-patient percentage Standard Deviation 38.93
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 (Q3) Based on Attempts With Sexual Stimulation- Change From Baseline Week 4 (N=100)	70.78 per-patient percentage Standard Deviation 35.46
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 (Q3) Based on Attempts With Sexual Stimulation- Change From Baseline Week 6 (N=97)	71.23 per-patient percentage Standard Deviation 35.79
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 (Q3) Based on Attempts With Sexual Stimulation- Change From Baseline Week 6 LOCF (N=102)	72.15 per-patient percentage Standard Deviation 35.41
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 (Q3) Based on Attempts With Sexual Stimulation- Change From Baseline Week 6 Endpoint (N=100)	71.60 per-patient percentage Standard Deviation 35.55

SECONDARY outcome

Timeframe: Week 4 and Week 6

Population: MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Mean change: mean change at each visit minus mean at Week 2. Percent of "Yes" responses to SEP Q3 based on attempts with sexual stimulation (SS): 100\* (number of attempts with SS where SEP Q3 \[Did your erection last long enough for you to have successful intercourse?\] = Yes)/(number of attempts with SS where SEP Q3 was answered Yes or No)

Outcome measures

Outcome measures
Measure	Open Label Sildenafil Citrate n=112 Participants Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 (Q3) Based on Attempts With Sexual Stimulation- Change From Week 2 Week 4 (N=110)	13.56 per-patient percentage Standard Deviation 30.89
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 (Q3) Based on Attempts With Sexual Stimulation- Change From Week 2 Week 6 (N=107)	14.25 per-patient percentage Standard Deviation 31.31
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 (Q3) Based on Attempts With Sexual Stimulation- Change From Week 2 Week 6 LOCF (N=112)	14.51 per-patient percentage Standard Deviation 31.77
Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 (Q3) Based on Attempts With Sexual Stimulation- Change From Week 2 Week 6 Endpoint (N=110)	14.77 per-patient percentage Standard Deviation 32.00

SECONDARY outcome

Timeframe: Week 2, Week 4 and Week 6

Population: MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

Mean change: mean change at each visit minus mean at baseline. Percent of Grade 1 (1=increase in size, but not hard) erection hardness based on occasions: 100\*(number of occasions where Erection Hardness Scale Answer 1)/(number of occasions where Erection Hardness Scale was answered)

Outcome measures

Outcome measures
Measure	Open Label Sildenafil Citrate n=103 Participants Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Mean Per-Patient Percentage of Grade 1 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation- Change From Baseline Grade 1 (Week 2) N=103	-12.58 per-patient percentage Standard Deviation 37.77
Mean Per-Patient Percentage of Grade 1 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation- Change From Baseline Grade 1 (Week 4) N=101	-20.55 per-patient percentage Standard Deviation 35.04
Mean Per-Patient Percentage of Grade 1 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation- Change From Baseline Grade 1 (Week 6) N=98	-22.53 per-patient percentage Standard Deviation 36.64
Mean Per-Patient Percentage of Grade 1 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation- Change From Baseline Grade 1 (Week 6 LOCF) N=103	-21.44 per-patient percentage Standard Deviation 36.06
Mean Per-Patient Percentage of Grade 1 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation- Change From Baseline Grade 1 (Week 6 Endpoint) N=101	-21.86 per-patient percentage Standard Deviation 36.29

SECONDARY outcome

Timeframe: Week 4 and Week 6

Population: MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 1 (1=increase in size, but not hard) erection hardness based on occasions: 100\*(number of occasions where Erection Hardness Scale Answer 1)/(number of occasions where Erection Hardness Scale was answered)

Outcome measures

Outcome measures
Measure	Open Label Sildenafil Citrate n=112 Participants Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Mean Per-Patient Percentage of Grade 1 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation- Change From Week 2 Grade 1 (Week 6 Endpoint) N=110	-7.57 per-patient percentage Standard Deviation 24.40
Mean Per-Patient Percentage of Grade 1 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation- Change From Week 2 Grade 1 (Week 4) N=110	-6.79 per-patient percentage Standard Deviation 22.58
Mean Per-Patient Percentage of Grade 1 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation- Change From Week 2 Grade 1 (Week 6) N=107	-6.85 per-patient percentage Standard Deviation 23.02
Mean Per-Patient Percentage of Grade 1 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation- Change From Week 2 Grade 1 (Week 6 LOCF) N=112	-7.43 per-patient percentage Standard Deviation 24.20

SECONDARY outcome

Timeframe: Week 2, Week 4 and Week 6

Population: MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

Mean change: mean change at each visit minus mean at baseline. Percent of Grade 2 (2= hard, but not hard enough for penetration) erection hardness based on occasions: 100\*(number of occasions where Erection Hardness Scale Answer 2)/(number of occasions where Erection Hardness Scale was answered)

Outcome measures

Outcome measures
Measure	Open Label Sildenafil Citrate n=103 Participants Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Mean Per-Patient Percentage of Grade 2 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline Grade 2 (Week 2) N=103	-9.87 Per-patient percentage Standard Deviation 34.44
Mean Per-Patient Percentage of Grade 2 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline Grade 2 (Week 4) N=101	-11.74 Per-patient percentage Standard Deviation 32.80
Mean Per-Patient Percentage of Grade 2 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline Grade 2 (Week 6) N=98	-12.78 Per-patient percentage Standard Deviation 33.56
Mean Per-Patient Percentage of Grade 2 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline Grade 2 (Week 6 LOCF) N=103	-13.13 Per-patient percentage Standard Deviation 33.94
Mean Per-Patient Percentage of Grade 2 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline Grade 2 (Week 6 Endpoint) N=101	-12.40 Per-patient percentage Standard Deviation 33.13

SECONDARY outcome

Timeframe: Week 4 and Week 6

Population: MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 2 (2= hard, but not hard enough for penetration) erection hardness based on occasions: 100\*(number of occasions where Erection Hardness Scale Answer 2)/(number of occasions where Erection Hardness Scale was answered)

Outcome measures

Outcome measures
Measure	Open Label Sildenafil Citrate n=112 Participants Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Mean Per-Patient Percentage of Grade 2 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2 Grade 2 (Week 4) N=110	-2.39 per-patient percentage Standard Deviation 22.00
Mean Per-Patient Percentage of Grade 2 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2 Grade 2 (Week 6) N=107	-1.91 per-patient percentage Standard Deviation 20.73
Mean Per-Patient Percentage of Grade 2 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2 Grade 2 (Week 6 LOCF) N=112	-2.71 per-patient percentage Standard Deviation 22.28
Mean Per-Patient Percentage of Grade 2 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2 Grade 2 (Week 6 Endpoint) N=110	-2.76 per-patient percentage Standard Deviation 22.48

SECONDARY outcome

Timeframe: Week 2, Week 4 and Week 6

Population: MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Mean change: mean change at each visit minus mean at baseline. Percent of Grade 3 (3= hard enough for penetration \[but not completely hard\]) erection hardness based on occasions: 100\*(number of occasions where Erection Hardness Scale Answer 3)/(number of occasions where Erection Hardness Scale was answered)

Outcome measures

Outcome measures
Measure	Open Label Sildenafil Citrate n=103 Participants Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Mean Per-Patient Percentage of Grade 3 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline Grade 3 (Week 2) N=103	-10.82 per-patient percentage Standard Deviation 56.75
Mean Per-Patient Percentage of Grade 3 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline Grade 3 (Week 4) N=101	-29.16 per-patient percentage Standard Deviation 59.81
Mean Per-Patient Percentage of Grade 3 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline Grade 3 (Week 6) N=98	-30.79 per-patient percentage Standard Deviation 60.90
Mean Per-Patient Percentage of Grade 3 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline Grade 3 (Week 6 LOCF) N=103	-30.27 per-patient percentage Standard Deviation 61.70
Mean Per-Patient Percentage of Grade 3 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline Grade 3 (Week 6 Endpoint) N=101	-30.87 per-patient percentage Standard Deviation 60.54

SECONDARY outcome

Timeframe: Week 4 and Week 6

Population: MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 3 (3= hard enough for penetration \[but not completely hard\]) erection hardness based on occasions: 100\*(number of occasions where Erection Hardness Scale Answer 3)/(number of occasions where Erection Hardness Scale was answered)

Outcome measures

Outcome measures
Measure	Open Label Sildenafil Citrate n=112 Participants Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Mean Per-Patient Percentage of Grade 3 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2 Grade 1 (Week 4) N=110	-18.36 per-patient percentage Standard Deviation 46.03
Mean Per-Patient Percentage of Grade 3 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2 Grade 1 (Week 6) N=107	-22.16 per-patient percentage Standard Deviation 45.24
Mean Per-Patient Percentage of Grade 3 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2 Grade 1 (Week 6 LOCF) N=112	-20.28 per-patient percentage Standard Deviation 45.86
Mean Per-Patient Percentage of Grade 3 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2 Grade 1 (Week 6 Endpoint) N=110	-20.65 per-patient percentage Standard Deviation 46.20

SECONDARY outcome

Timeframe: Week 2, Week 4 and Week 6

Population: MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

Mean change: mean change at each visit minus mean at baseline. Percent of Grade 4 (4= completely hard) erection hardness based on occasions: 100\*(number of occasions where Erection Hardness Scale Answer 4)/(number of occasions where Erection Hardness Scale was answered)

Outcome measures

Outcome measures
Measure	Open Label Sildenafil Citrate n=103 Participants Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Mean Per-Patient Percentage of Grade 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline Grade 4 (Week 2) N=103	33.27 per-patient percentage Standard Deviation 41.43
Mean Per-Patient Percentage of Grade 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline Grade 4 (Week 4) N=101	61.45 per-patient percentage Standard Deviation 44.77
Mean Per-Patient Percentage of Grade 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline Grade 4 (Week 6) N=98	66.10 per-patient percentage Standard Deviation 45.15
Mean Per-Patient Percentage of Grade 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline Grade 4 (Week 6 LOCF) N=103	64.84 per-patient percentage Standard Deviation 45.70
Mean Per-Patient Percentage of Grade 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline Grade 4 (Week 6 Endpoint) N=101	65.13 per-patient percentage Standard Deviation 45.56

SECONDARY outcome

Timeframe: Week 4 and Week 6

Population: MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2

Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 4 (4= completely hard) erection hardness based on occasions: 100\*(number of occasions where Erection Hardness Scale Answer 4)/(number of occasions where Erection Hardness Scale was answered)

Outcome measures

Outcome measures
Measure	Open Label Sildenafil Citrate n=112 Participants Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Mean Per-Patient Percentage of Grade 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2 Grade 4 (Week 6 LOCF) N=112	30.43 per-patient percentage Standard Deviation 41.88
Mean Per-Patient Percentage of Grade 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2 Grade 4 (Week 4) N=110	27.53 per-patient percentage Standard Deviation 40.19
Mean Per-Patient Percentage of Grade 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2 Grade 4 (Week 6) N=107	30.92 per-patient percentage Standard Deviation 41.90
Mean Per-Patient Percentage of Grade 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2 Grade 4 (Week 6 Endpoint) N=110	30.98 per-patient percentage Standard Deviation 42.06

SECONDARY outcome

Timeframe: Week 2, Week 4 and Week 6

Population: MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Mean change: mean change at each visit minus mean at baseline. Percent of Grade 3 (hard enough for penetration \[but not completely hard\]) or 4 (completely hard) erection hardness based on occasions: 100\*(number of occasions where Erection Hardness Scale Answer 3 or 4)/ (number of occasions where Erection Hardness Scale was answered)

Outcome measures

Outcome measures
Measure	Open Label Sildenafil Citrate n=103 Participants Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Mean Per-Patient Percentage of Grade 3 or 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline Grade 3 or 4 (Week 2) N=103	22.45 per-patient percentage Standard Deviation 46.10
Mean Per-Patient Percentage of Grade 3 or 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline Grade 3 or 4 (Week 4) N=101	32.30 per-patient percentage Standard Deviation 42.15
Mean Per-Patient Percentage of Grade 3 or 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline Grade 3 or 4 (Week 6) N=98	35.31 per-patient percentage Standard Deviation 43.52
Mean Per-Patient Percentage of Grade 3 or 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline Grade 3 or 4 (Week 6 LOCF) N=103	34.57 per-patient percentage Standard Deviation 43.48
Mean Per-Patient Percentage of Grade 3 or 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline Grade 3 or 4 (Week 6 Endpoint) N=101	34.26 per-patient percentage Standard Deviation 43.29

SECONDARY outcome

Timeframe: Week 4 and Week 6

Population: MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.

Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 3 (hard enough for penetration \[but not completely hard\]) or 4 (completely hard) erection hardness based on occasions: 100\*(number of occasions where Erection Hardness Scale Answer 3 or 4)/ (number of occasions where Erection Hardness Scale was answered)

Outcome measures

Outcome measures
Measure	Open Label Sildenafil Citrate n=110 Participants Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Mean Per-Patient Percentage of Grade 3 or 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2 Grade 3 or 4 (Week 4) N=110	9.18 per-patient percentage Standard Deviation 29.45
Mean Per-Patient Percentage of Grade 3 or 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2 Grade 3 or 4 (Week 6) N=107	8.75 per-patient percentage Standard Deviation 29.26
Mean Per-Patient Percentage of Grade 3 or 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2 Grade 3 or 4 (Week 6 LOCF ) N=112	10.15 per-patient percentage Standard Deviation 31.11
Mean Per-Patient Percentage of Grade 3 or 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2 Grade 3 or 4 (Week 6 Endpoint ) N=110	10.33 per-patient percentage Standard Deviation 31.36

Adverse Events

Open Label Sildenafil Citrate

Serious events: 0 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Open Label Sildenafil Citrate n=117 participants at risk Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
Nervous system disorders Headache	15.4% 18/117
Vascular disorders Hot Flush	8.5% 10/117
Respiratory, thoracic and mediastinal disorders Nasal Congestion	2.6% 3/117
Vascular disorders Flushing	2.6% 3/117
Gastrointestinal disorders Gastritis	2.6% 3/117

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \<60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \<12 mo from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
Publication restrictions are in place

Restriction type: OTHER