Trial Outcomes & Findings for Treatment of Erectile Dysfunction II (NCT NCT01037218)
NCT ID: NCT01037218
Last Updated: 2015-06-19
Results Overview
Erectile Function domain: 0 - 5 scoring scale for each of 6 questions (scale: 0/min/poor - 30/max/good). Over last month: How often were you able to get erection? When you had erections with stimulation, how often were your erections hard enough for penetration? When you attempted intercourse, how often were you able to penetrate your partner? How often were you able to maintain your erection after penetrating your partner? How difficult was it to maintain your erection to completion of intercourse? How do you rate your confidence that you can get \& keep your erection?
COMPLETED
PHASE3
601 participants
Baseline and Week 12
2015-06-19
Participant Flow
First Subject enrolled 28-Sep-2009
Participant milestones
| Measure |
Udenafil 50 mg
Udenafil 50 mg tablets
|
Udenafil 100 mg
Udenafil 100 mg tablets
|
Udenafil 150mg
Udenafil 150mg tablets
|
Placebo
Placebo tablets
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
147
|
149
|
155
|
150
|
|
Overall Study
Safety Population
|
147
|
148
|
154
|
150
|
|
Overall Study
mITT Population
|
141
|
140
|
147
|
141
|
|
Overall Study
COMPLETED
|
131
|
128
|
134
|
134
|
|
Overall Study
NOT COMPLETED
|
16
|
21
|
21
|
16
|
Reasons for withdrawal
| Measure |
Udenafil 50 mg
Udenafil 50 mg tablets
|
Udenafil 100 mg
Udenafil 100 mg tablets
|
Udenafil 150mg
Udenafil 150mg tablets
|
Placebo
Placebo tablets
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
2
|
2
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
1
|
5
|
|
Overall Study
Lost to Follow-up
|
3
|
5
|
4
|
2
|
|
Overall Study
Withdrawal by Subject
|
6
|
7
|
7
|
4
|
|
Overall Study
Partner Withdrew Consent
|
0
|
3
|
2
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
2
|
2
|
|
Overall Study
Various
|
3
|
2
|
3
|
1
|
Baseline Characteristics
Treatment of Erectile Dysfunction II
Baseline characteristics by cohort
| Measure |
Udenafil 50 mg
n=147 Participants
Udenafil 50 mg tablets
|
Udenafil 100 mg
n=149 Participants
Udenafil 100 mg tablets
|
Udenafil 150mg
n=155 Participants
Udenafil 150mg tablets
|
Placebo
n=150 Participants
Placebo tablets
|
Total
n=601 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
59.1 years
STANDARD_DEVIATION 8.92 • n=99 Participants
|
56.8 years
STANDARD_DEVIATION 10.22 • n=107 Participants
|
58.7 years
STANDARD_DEVIATION 9.48 • n=206 Participants
|
58.9 years
STANDARD_DEVIATION 10.31 • n=7 Participants
|
58.4 years
STANDARD_DEVIATION 9.77 • n=31 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
147 Participants
n=99 Participants
|
149 Participants
n=107 Participants
|
155 Participants
n=206 Participants
|
150 Participants
n=7 Participants
|
601 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
29 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
140 Participants
n=99 Participants
|
143 Participants
n=107 Participants
|
145 Participants
n=206 Participants
|
142 Participants
n=7 Participants
|
570 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
69 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
129 Participants
n=99 Participants
|
125 Participants
n=107 Participants
|
139 Participants
n=206 Participants
|
127 Participants
n=7 Participants
|
520 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
147 participants
n=99 Participants
|
149 participants
n=107 Participants
|
155 participants
n=206 Participants
|
150 participants
n=7 Participants
|
601 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: mITT, LOCF
Erectile Function domain: 0 - 5 scoring scale for each of 6 questions (scale: 0/min/poor - 30/max/good). Over last month: How often were you able to get erection? When you had erections with stimulation, how often were your erections hard enough for penetration? When you attempted intercourse, how often were you able to penetrate your partner? How often were you able to maintain your erection after penetrating your partner? How difficult was it to maintain your erection to completion of intercourse? How do you rate your confidence that you can get \& keep your erection?
Outcome measures
| Measure |
Udenafil 50 mg
n=141 Participants
Udenafil 50 mg tablets
|
Udenafil 100 mg
n=140 Participants
Udenafil 100 mg tablets
|
Udenafil 150mg
n=147 Participants
Udenafil 150mg tablets
|
Placebo
n=141 Participants
Placebo tablets
|
|---|---|---|---|---|
|
Change in Erectile Function Domain Assessed by International Index of Erectile Function (IIEF), Baseline to Final Visit/Week 12, mITT (Modified Intent-to-Treat), LOCF (Last Observation Carried Forward)
|
3.79 Units on a Scale
Interval 2.58 to 5.0
|
6.14 Units on a Scale
Interval 4.92 to 7.37
|
7.94 Units on a Scale
Interval 6.75 to 9.12
|
0.41 Units on a Scale
Interval -0.81 to 1.62
|
PRIMARY outcome
Timeframe: Baseline and Weeks 1-12Population: mITT
Question 2 SEP: Were you able to insert your penis into your partner's vagina? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.
Outcome measures
| Measure |
Udenafil 50 mg
n=141 Participants
Udenafil 50 mg tablets
|
Udenafil 100 mg
n=140 Participants
Udenafil 100 mg tablets
|
Udenafil 150mg
n=147 Participants
Udenafil 150mg tablets
|
Placebo
n=141 Participants
Placebo tablets
|
|---|---|---|---|---|
|
Changes in Sexual Encounter Profile (SEP), Question 2, Change From Baseline to Overall Study/Weeks 1-12, mITT
|
14.47 Percentage of Yes Reponses
Interval 9.6 to 19.33
|
19.34 Percentage of Yes Reponses
Interval 14.46 to 24.23
|
27.12 Percentage of Yes Reponses
Interval 22.39 to 31.85
|
-5.72 Percentage of Yes Reponses
Interval -10.57 to -0.86
|
PRIMARY outcome
Timeframe: Baseline and Weeks 1-12Population: mITT
Question 3 SEP: Did your erection last long enough for you to have successful completion of intercourse? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.
Outcome measures
| Measure |
Udenafil 50 mg
n=141 Participants
Udenafil 50 mg tablets
|
Udenafil 100 mg
n=140 Participants
Udenafil 100 mg tablets
|
Udenafil 150mg
n=147 Participants
Udenafil 150mg tablets
|
Placebo
n=141 Participants
Placebo tablets
|
|---|---|---|---|---|
|
Changes in Sexual Encounter Profile (SEP), Question 3, Change From Baseline to Overall Study/Weeks 1-12, mITT
|
33.24 Percentage of Yes Responses
Interval 27.81 to 38.67
|
38.34 Percentage of Yes Responses
Interval 32.89 to 43.8
|
46.93 Percentage of Yes Responses
Interval 41.66 to 52.2
|
11.53 Percentage of Yes Responses
Interval 6.1 to 16.95
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: mITT, LOCF
Satisfaction of Intercourse domain: 0 (poor) - 5/(good) scoring scale for each of 3 questions (0-15/good). Over last month: How many times have you attempted sexual intercourse? When you attempted intercourse, how often was it satisfactory for you? How much have you enjoyed sexual intercourse?
Outcome measures
| Measure |
Udenafil 50 mg
n=141 Participants
Udenafil 50 mg tablets
|
Udenafil 100 mg
n=140 Participants
Udenafil 100 mg tablets
|
Udenafil 150mg
n=147 Participants
Udenafil 150mg tablets
|
Placebo
n=141 Participants
Placebo tablets
|
|---|---|---|---|---|
|
Change in Satisfaction of Intercourse Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF
|
1.49 Units on a Scale
Interval 0.97 to 2.0
|
2.25 Units on a Scale
Interval 1.73 to 2.76
|
2.86 Units on a Scale
Interval 2.36 to 3.36
|
-0.04 Units on a Scale
Interval -0.55 to 0.47
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: mITT, LOCF
Orgasmic Function domain: 0/poor - 5/good scoring scale for each of 2 questions (0-10/good). Over last month, when you had sexual stimulation or intercourse how often did you ejaculate? When you had sexual stimulation or intercourse how often did you have the feeling of orgasm (with or without ejaculation)?
Outcome measures
| Measure |
Udenafil 50 mg
n=141 Participants
Udenafil 50 mg tablets
|
Udenafil 100 mg
n=140 Participants
Udenafil 100 mg tablets
|
Udenafil 150mg
n=147 Participants
Udenafil 150mg tablets
|
Placebo
n=141 Participants
Placebo tablets
|
|---|---|---|---|---|
|
Change in Orgasmic Function Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF
|
0.84 Units on a Scale
Interval 0.38 to 1.29
|
1.77 Units on a Scale
Interval 1.32 to 2.23
|
1.78 Units on a Scale
Interval 1.33 to 2.22
|
0.25 Units on a Scale
Interval -0.21 to 0.7
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: mITT, LOCF
Sexual Desire domain: 1/poor - 5/good scoring scale for each of 2 questions (2-10/good). Over last month, how often have you felt sexual desire? How would you rate your level of sexual desire?
Outcome measures
| Measure |
Udenafil 50 mg
n=141 Participants
Udenafil 50 mg tablets
|
Udenafil 100 mg
n=140 Participants
Udenafil 100 mg tablets
|
Udenafil 150mg
n=147 Participants
Udenafil 150mg tablets
|
Placebo
n=141 Participants
Placebo tablets
|
|---|---|---|---|---|
|
Change in Sexual Desire Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF
|
0.30 Units on a Scale
Interval 0.04 to 0.57
|
0.65 Units on a Scale
Interval 0.38 to 0.92
|
0.65 Units on a Scale
Interval 0.39 to 0.91
|
-0.06 Units on a Scale
Interval -0.32 to 0.21
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: mITT, LOCF
Overall Satisfaction domain: 1/poor - 5/good scoring scale for each of 2 questions (2-10/good). Over last month, how satisfied have you been with your overall sex life? How satisfied have you been with your sexual relationship with your partner?
Outcome measures
| Measure |
Udenafil 50 mg
n=141 Participants
Udenafil 50 mg tablets
|
Udenafil 100 mg
n=140 Participants
Udenafil 100 mg tablets
|
Udenafil 150mg
n=147 Participants
Udenafil 150mg tablets
|
Placebo
n=141 Participants
Placebo tablets
|
|---|---|---|---|---|
|
Change in Overall Satisfaction Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF
|
1.46 Units on a Scale
Interval 1.07 to 1.85
|
2.15 Units on a Scale
Interval 1.76 to 2.55
|
2.69 Units on a Scale
Interval 2.31 to 3.07
|
0.60 Units on a Scale
Interval 0.21 to 0.99
|
SECONDARY outcome
Timeframe: Week 12Population: mITT
While Using the Study Medication, Did You Feel That Your Erections Improved (Yes Responders)
Outcome measures
| Measure |
Udenafil 50 mg
n=141 Participants
Udenafil 50 mg tablets
|
Udenafil 100 mg
n=140 Participants
Udenafil 100 mg tablets
|
Udenafil 150mg
n=147 Participants
Udenafil 150mg tablets
|
Placebo
n=141 Participants
Placebo tablets
|
|---|---|---|---|---|
|
Global Assessment Questionnaire (GAQ), Week 12/Final Visit, mITT Population
|
68 Yes Responders
|
85 Yes Responders
|
105 Yes Responders
|
33 Yes Responders
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: mITT, LOCF
EDITS -sum of responses (mapped to 0/bad-4/good scale, 11 questions standardized to scale of 100): How satisfied are you w/treatment? How likely to continue?, During past 4 wks, has treatment met expectations? How easy to use ? How satisfied w/how quickly it works? How long it lasts? How confident has it made you feel about ability to engage in sex? How satisfied is partner is with treatment effects? How does your partner feel about continuing use? How natural did process of achieving erection feel? Compared to before erection problem, how natural did erection feel in terms of hardness?
Outcome measures
| Measure |
Udenafil 50 mg
n=141 Participants
Udenafil 50 mg tablets
|
Udenafil 100 mg
n=140 Participants
Udenafil 100 mg tablets
|
Udenafil 150mg
n=147 Participants
Udenafil 150mg tablets
|
Placebo
n=141 Participants
Placebo tablets
|
|---|---|---|---|---|
|
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Derived Score, Subject Version, Week 12/Final Visit, LOCF, mITT
|
57.20 Units on a Scale
Interval 53.13 to 61.27
|
64.16 Units on a Scale
Interval 60.05 to 68.27
|
71.56 Units on a Scale
Interval 67.59 to 75.53
|
44.55 Units on a Scale
Interval 40.49 to 48.61
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: mITT
PASE: Chose one: 1) No evidence of tumescence or erection 2) partial tumescence or erection (not likely to be sufficient for penetration) 3) greater tumescence or erection sufficient for vaginal penetration, but not fully rigid 4) full rigidity; scale 1/poor, no evidence of erection - 4/good, full rigidity
Outcome measures
| Measure |
Udenafil 50 mg
n=141 Participants
Udenafil 50 mg tablets
|
Udenafil 100 mg
n=140 Participants
Udenafil 100 mg tablets
|
Udenafil 150mg
n=147 Participants
Udenafil 150mg tablets
|
Placebo
n=141 Participants
Placebo tablets
|
|---|---|---|---|---|
|
Change From Baseline to Week 12/Final Visit in Mean Patient Self-Assessment of Erection (PSAE), mITT Population
|
0.39 Units on a Scale
Interval 0.29 to 0.49
|
0.49 Units on a Scale
Interval 0.39 to 0.6
|
0.78 Units on a Scale
Interval 0.69 to 0.88
|
-0.05 Units on a Scale
Interval -0.15 to 0.05
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1-12Population: mITT
SEP Question 1: Were you able to achieve at least some erection (some enlargement of the penis)? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.
Outcome measures
| Measure |
Udenafil 50 mg
n=141 Participants
Udenafil 50 mg tablets
|
Udenafil 100 mg
n=140 Participants
Udenafil 100 mg tablets
|
Udenafil 150mg
n=147 Participants
Udenafil 150mg tablets
|
Placebo
n=141 Participants
Placebo tablets
|
|---|---|---|---|---|
|
Change in SEP Question 1, Change From Baseline to Overall/Weeks 1-12, mITT
|
3.39 Percentage Yes Responses
Interval -0.18 to 6.97
|
3.16 Percentage Yes Responses
Interval -0.44 to 6.75
|
9.28 Percentage Yes Responses
Interval 5.8 to 12.76
|
-11.78 Percentage Yes Responses
Interval -15.36 to -8.2
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1-12Population: mITT
SEP Question 4: Were you satisfied with the hardness of your erection? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.
Outcome measures
| Measure |
Udenafil 50 mg
n=141 Participants
Udenafil 50 mg tablets
|
Udenafil 100 mg
n=140 Participants
Udenafil 100 mg tablets
|
Udenafil 150mg
n=147 Participants
Udenafil 150mg tablets
|
Placebo
n=141 Participants
Placebo tablets
|
|---|---|---|---|---|
|
Change in SEP Question 4, Change From Baseline to Overall Study/Weeks 1-12, mITT
|
27.12 Percentage Yes Responses
Interval 21.85 to 32.38
|
37.92 Percentage Yes Responses
Interval 32.63 to 43.21
|
43.42 Percentage Yes Responses
Interval 38.31 to 48.54
|
9.61 Percentage Yes Responses
Interval 4.35 to 14.86
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1-12Population: mITT
SEP Question 5: Were you satisfied with this overall sexual experience? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.
Outcome measures
| Measure |
Udenafil 50 mg
n=141 Participants
Udenafil 50 mg tablets
|
Udenafil 100 mg
n=140 Participants
Udenafil 100 mg tablets
|
Udenafil 150mg
n=147 Participants
Udenafil 150mg tablets
|
Placebo
n=141 Participants
Placebo tablets
|
|---|---|---|---|---|
|
Change in SEP Question 5, Change From Baseline to Overall/Weeks 1-12, mITT
|
26.27 Percentage Yes Responses
Interval 20.86 to 31.68
|
36.93 Percentage Yes Responses
Interval 31.48 to 42.38
|
41.88 Percentage Yes Responses
Interval 36.62 to 47.14
|
7.53 Percentage Yes Responses
Interval 2.13 to 12.94
|
Adverse Events
Udenafil 50 mg
Udenafil 100 mg
Udenafil 150mg
Placebo
Serious adverse events
| Measure |
Udenafil 50 mg
n=147 participants at risk
Udenafil 50 mg tablets
|
Udenafil 100 mg
n=148 participants at risk
Udenafil 100 mg tablets
|
Udenafil 150mg
n=150 participants at risk；n=154 participants at risk
Udenafil 150mg tablets
|
Placebo
n=150 participants at risk
Placebo tablets
|
|---|---|---|---|---|
|
Cardiac disorders
Coronary Artery Stenosis
|
0.00%
0/147 • Twelve weeks
|
0.00%
0/148 • Twelve weeks
|
0.00%
0/154 • Twelve weeks
|
0.67%
1/150 • Twelve weeks
|
|
Infections and infestations
Endocarditis
|
0.68%
1/147 • Twelve weeks
|
0.00%
0/148 • Twelve weeks
|
0.00%
0/154 • Twelve weeks
|
0.00%
0/150 • Twelve weeks
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/147 • Twelve weeks
|
0.68%
1/148 • Twelve weeks
|
0.00%
0/154 • Twelve weeks
|
0.00%
0/150 • Twelve weeks
|
|
Cardiac disorders
Angina Unstable
|
0.00%
0/147 • Twelve weeks
|
0.00%
0/148 • Twelve weeks
|
0.65%
1/154 • Twelve weeks
|
0.00%
0/150 • Twelve weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/147 • Twelve weeks
|
0.00%
0/148 • Twelve weeks
|
0.65%
1/154 • Twelve weeks
|
0.00%
0/150 • Twelve weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Squamous Cell Carcinoma Stage Unspecified
|
0.00%
0/147 • Twelve weeks
|
0.00%
0/148 • Twelve weeks
|
0.65%
1/154 • Twelve weeks
|
0.00%
0/150 • Twelve weeks
|
Other adverse events
| Measure |
Udenafil 50 mg
n=147 participants at risk
Udenafil 50 mg tablets
|
Udenafil 100 mg
n=148 participants at risk
Udenafil 100 mg tablets
|
Udenafil 150mg
n=150 participants at risk；n=154 participants at risk
Udenafil 150mg tablets
|
Placebo
n=150 participants at risk
Placebo tablets
|
|---|---|---|---|---|
|
Infections and infestations
Upper Respiratory Tract Infection
|
4.8%
7/147 • Twelve weeks
|
4.7%
7/148 • Twelve weeks
|
4.0%
6/150 • Twelve weeks
|
0.00%
0/150 • Twelve weeks
|
|
Infections and infestations
Nasopharyngitis
|
4.1%
6/147 • Twelve weeks
|
1.4%
2/148 • Twelve weeks
|
3.3%
5/150 • Twelve weeks
|
3.3%
5/150 • Twelve weeks
|
|
Infections and infestations
Sinusitis
|
1.4%
2/147 • Twelve weeks
|
2.7%
4/148 • Twelve weeks
|
1.3%
2/150 • Twelve weeks
|
1.3%
2/150 • Twelve weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
0.68%
1/147 • Twelve weeks
|
4.7%
7/148 • Twelve weeks
|
2.7%
4/150 • Twelve weeks
|
0.00%
0/150 • Twelve weeks
|
|
Nervous system disorders
Headache
|
2.7%
4/147 • Twelve weeks
|
6.8%
10/148 • Twelve weeks
|
10.0%
15/150 • Twelve weeks
|
0.00%
0/150 • Twelve weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
4.8%
7/147 • Twelve weeks
|
4.1%
6/148 • Twelve weeks
|
2.7%
4/150 • Twelve weeks
|
1.3%
2/150 • Twelve weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.68%
1/147 • Twelve weeks
|
2.0%
3/148 • Twelve weeks
|
2.0%
3/150 • Twelve weeks
|
0.00%
0/150 • Twelve weeks
|
|
Vascular disorders
Flushing
|
6.1%
9/147 • Twelve weeks
|
5.4%
8/148 • Twelve weeks
|
6.7%
10/150 • Twelve weeks
|
0.00%
0/150 • Twelve weeks
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
2.0%
3/147 • Twelve weeks
|
2.7%
4/148 • Twelve weeks
|
0.00%
0/150 • Twelve weeks
|
0.67%
1/150 • Twelve weeks
|
|
Investigations
Blood Pressure Increased
|
2.0%
3/147 • Twelve weeks
|
0.00%
0/148 • Twelve weeks
|
0.00%
0/150 • Twelve weeks
|
0.67%
1/150 • Twelve weeks
|
Additional Information
Grexan Wulff, Manager Regulatory Affairs
Warner Chilcott
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60