Trial Outcomes & Findings for Treatment of Erectile Dysfunction I (NCT NCT01037244)
NCT ID: NCT01037244
Last Updated: 2011-12-22
Results Overview
Erectile Function domain: 0 (poor) - 5/(good) scoring scale for each of 6 questions (0-30/max/good). Over last month: How often were you able to get an erection during sex? 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
618 participants
Baseline and Week 12
2011-12-22
Participant Flow
Enrollment began 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
|
154
|
152
|
158
|
154
|
|
Overall Study
mITT (Modified Intent-to-Treat)
|
150
|
148
|
154
|
153
|
|
Overall Study
Safety Population
|
155
|
150
|
159
|
152
|
|
Overall Study
COMPLETED
|
141
|
138
|
144
|
140
|
|
Overall Study
NOT COMPLETED
|
13
|
14
|
14
|
14
|
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
|
3
|
2
|
6
|
3
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
4
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
5
|
3
|
5
|
|
Overall Study
Partner Withdrew Consent
|
2
|
1
|
0
|
0
|
|
Overall Study
Various
|
3
|
2
|
1
|
1
|
Baseline Characteristics
Treatment of Erectile Dysfunction I
Baseline characteristics by cohort
| Measure |
Udenafil 50 mg
n=154 Participants
Udenafil 50 mg tablets
|
Udenafil 100 mg
n=152 Participants
Udenafil 100 mg tablets
|
Udenafil 150mg
n=158 Participants
Udenafil 150mg tablets
|
Placebo
n=154 Participants
Placebo tablets
|
Total
n=618 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
|
59.0 years
STANDARD_DEVIATION 10.03 • n=93 Participants
|
59.5 years
STANDARD_DEVIATION 9.69 • n=4 Participants
|
58.5 years
STANDARD_DEVIATION 10.75 • n=27 Participants
|
60.3 years
STANDARD_DEVIATION 10.16 • n=483 Participants
|
59.3 years
STANDARD_DEVIATION 10.17 • n=36 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
154 Participants
n=93 Participants
|
152 Participants
n=4 Participants
|
158 Participants
n=27 Participants
|
154 Participants
n=483 Participants
|
618 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
154 participants
n=93 Participants
|
152 participants
n=4 Participants
|
158 participants
n=27 Participants
|
154 participants
n=483 Participants
|
618 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Last Observation Carried Forward (LOCF), Modified Intent-to-Treat (mITT)
Erectile Function domain: 0 (poor) - 5/(good) scoring scale for each of 6 questions (0-30/max/good). Over last month: How often were you able to get an erection during sex? 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=150 Participants
Udenafil 50 mg tablets
|
Udenafil 100 mg
n=148 Participants
Udenafil 100 mg tablets
|
Udenafil 150mg
n=154 Participants
Udenafil 150mg tablets
|
Placebo
n=153 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)
|
4.85 units on a scale
95% Confidence Interval 7.78 • Interval 3.61 to 6.08
|
6.98 units on a scale
95% Confidence Interval 7.82 • Interval 5.75 to 8.22
|
7.76 units on a scale
95% Confidence Interval 8.53 • Interval 6.54 to 8.98
|
-0.19 units on a scale
95% Confidence Interval 5.31 • Interval -1.42 to 1.03
|
PRIMARY outcome
Timeframe: Baseline and Weeks 1 - 12Population: Modified Intent-to-Treat (mITT)
Question 2 SEP: Were you able to insert your penis into your partner's vagina? yes/no response; no scale. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period.
Outcome measures
| Measure |
Udenafil 50 mg
n=150 Participants
Udenafil 50 mg tablets
|
Udenafil 100 mg
n=148 Participants
Udenafil 100 mg tablets
|
Udenafil 150mg
n=154 Participants
Udenafil 150mg tablets
|
Placebo
n=153 Participants
Placebo tablets
|
|---|---|---|---|---|
|
Change in Sexual Encounter Profile (SEP), Question 2, Change From Baseline to Overall Study/Weeks 1-12, mITT
|
16.74 Percentage Yes Responders
Interval 11.71 to 21.78
|
27.16 Percentage Yes Responders
Interval 22.13 to 32.18
|
29.65 Percentage Yes Responders
Interval 24.71 to 34.6
|
-1.86 Percentage Yes Responders
Interval -6.88 to 3.16
|
PRIMARY outcome
Timeframe: Baseline and Weeks 1 - 12Population: Modified Intent-to-Treat (mITT)
Question 3 SEP: Did your erection last long enough for you to have successful completion of intercourse? yes/no response; no scale. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period.
Outcome measures
| Measure |
Udenafil 50 mg
n=150 Participants
Udenafil 50 mg tablets
|
Udenafil 100 mg
n=148 Participants
Udenafil 100 mg tablets
|
Udenafil 150mg
n=154 Participants
Udenafil 150mg tablets
|
Placebo
n=153 Participants
Placebo tablets
|
|---|---|---|---|---|
|
Change in SEP Question 3, Change From Baseline to Overall Study/Weeks 1-12, mITT
|
31.17 Percentage Yes Responders
Interval 25.85 to 36.5
|
38.78 Percentage Yes Responders
Interval 33.46 to 44.1
|
49.00 Percentage Yes Responders
Interval 43.76 to 54.23
|
11.20 Percentage Yes Responders
Interval 5.87 to 16.52
|
SECONDARY outcome
Timeframe: Week 12Population: mITT Population
Outcome measures
| Measure |
Udenafil 50 mg
n=150 Participants
Udenafil 50 mg tablets
|
Udenafil 100 mg
n=148 Participants
Udenafil 100 mg tablets
|
Udenafil 150mg
n=154 Participants
Udenafil 150mg tablets
|
Placebo
n=153 Participants
Placebo tablets
|
|---|---|---|---|---|
|
Global Assessment Questionnaire (GAQ), While Using the Study Medication, Did You Feel That Your Erections Improved? (Yes Responders), Week 12/Final Visit, mITT Population
|
82 participants
|
92 participants
|
111 participants
|
26 participants
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: mITT Population
PSAE, select one of the following: 1) no evidence of any tumescence or erection, 2) partial tumescence or erection (not likely to be sufficient for penetration), 3) great tumescence or erection sufficient for vaginal penetration, but not fully rigid, 4) full rigidity, scale 1/no evidence of erection (min) to 4/full erection (max)
Outcome measures
| Measure |
Udenafil 50 mg
n=150 Participants
Udenafil 50 mg tablets
|
Udenafil 100 mg
n=148 Participants
Udenafil 100 mg tablets
|
Udenafil 150mg
n=154 Participants
Udenafil 150mg tablets
|
Placebo
n=153 Participants
Placebo tablets
|
|---|---|---|---|---|
|
Change From Baseline to Week 12/Final Visit in Mean Patient Self-Assessment of Erection (PSAE), mITT Population
|
0.38 units on a scale
Interval 0.28 to 0.49
|
0.62 units on a scale
Interval 0.52 to 0.73
|
0.75 units on a scale
Interval 0.64 to 0.85
|
-0.06 units on a scale
Interval -0.16 to 0.05
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: mITT Population
EDITS-derived score is sum of responses, range 0/bad-4/good, 11 questions, standardized to scale of 100: How satisfied 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 made you feel to engage in sex? How satisfied do you believe your partner is with treatment effects? How does your partner feel about your 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=150 Participants
Udenafil 50 mg tablets
|
Udenafil 100 mg
n=148 Participants
Udenafil 100 mg tablets
|
Udenafil 150mg
n=154 Participants
Udenafil 150mg tablets
|
Placebo
n=153 Participants
Placebo tablets
|
|---|---|---|---|---|
|
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Derived Score, Subject Version, Week 12/ Final Visit, LOCF, mITT Population
|
59.59 units on a scale
Interval 55.6 to 63.59
|
65.49 units on a scale
Interval 61.48 to 69.5
|
71.31 units on a scale
Interval 67.38 to 75.23
|
42.92 units on a scale
Interval 38.97 to 46.87
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Last Observation Carried Forward (LOCF), Modified Intent-to-Treat (mITT)
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=150 Participants
Udenafil 50 mg tablets
|
Udenafil 100 mg
n=148 Participants
Udenafil 100 mg tablets
|
Udenafil 150mg
n=154 Participants
Udenafil 150mg tablets
|
Placebo
n=153 Participants
Placebo tablets
|
|---|---|---|---|---|
|
Change in Satisfaction of Intercourse Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF
|
1.81 units on a scale
Interval 1.27 to 2.34
|
2.18 units on a scale
Interval 1.65 to 2.71
|
2.93 units on a scale
Interval 2.41 to 3.45
|
-0.09 units on a scale
Interval -0.61 to 0.44
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Last Observation Carried Forward (LOCF), Modified Intent-to-Treat (mITT)
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=150 Participants
Udenafil 50 mg tablets
|
Udenafil 100 mg
n=148 Participants
Udenafil 100 mg tablets
|
Udenafil 150mg
n=154 Participants
Udenafil 150mg tablets
|
Placebo
n=153 Participants
Placebo tablets
|
|---|---|---|---|---|
|
Change in Orgasmic Function Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF
|
1.37 units on a scale
Interval 0.92 to 1.82
|
1.60 units on a scale
Interval 1.16 to 2.05
|
1.93 units on a scale
Interval 1.49 to 2.37
|
-0.05 units on a scale
Interval -0.49 to 0.4
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Last Observation Carried Forward (LOCF), Modified Intent-to-Treat (mITT)
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=150 Participants
Udenafil 50 mg tablets
|
Udenafil 100 mg
n=148 Participants
Udenafil 100 mg tablets
|
Udenafil 150mg
n=154 Participants
Udenafil 150mg tablets
|
Placebo
n=153 Participants
Placebo tablets
|
|---|---|---|---|---|
|
Change in Sexual Desire Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF
|
0.45 units on a scale
Interval 0.18 to 0.71
|
0.61 units on a scale
Interval 0.35 to 0.88
|
0.73 units on a scale
Interval 0.47 to 0.99
|
-0.12 units on a scale
Interval -0.38 to 0.14
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Last Observation Carried Forward (LOCF), Modified Intent-to-Treat (mITT)
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=150 Participants
Udenafil 50 mg tablets
|
Udenafil 100 mg
n=148 Participants
Udenafil 100 mg tablets
|
Udenafil 150mg
n=154 Participants
Udenafil 150mg tablets
|
Placebo
n=153 Participants
Placebo tablets
|
|---|---|---|---|---|
|
Change in Overall Satisfaction Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF
|
1.98 units on a scale
Interval 1.59 to 2.37
|
2.08 units on a scale
Interval 1.69 to 2.47
|
2.88 units on a scale
Interval 2.5 to 3.26
|
0.32 units on a scale
Interval -0.06 to 0.71
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1 - 12Population: Modified Intent-to-Treat (mITT)
Question 1 SEP: Were you able to achieve at least some erection (some enlargement of the penis)? yes/no response. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period.
Outcome measures
| Measure |
Udenafil 50 mg
n=150 Participants
Udenafil 50 mg tablets
|
Udenafil 100 mg
n=148 Participants
Udenafil 100 mg tablets
|
Udenafil 150mg
n=154 Participants
Udenafil 150mg tablets
|
Placebo
n=153 Participants
Placebo tablets
|
|---|---|---|---|---|
|
Change in SEP Question 1, Change From Baseline to Overall/Weeks 1-12, mITT
|
0.60 Percentage of Yes Responders
Interval -3.11 to 4.32
|
7.55 Percentage of Yes Responders
Interval 3.86 to 11.25
|
7.42 Percentage of Yes Responders
Interval 3.79 to 11.06
|
-11.74 Percentage of Yes Responders
Interval -15.43 to -8.05
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1 - 12Population: Modified Intent-to-Treat (mITT)
Question 4 SEP: Were you satisfied with the hardness of your erection? yes/no response. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period.
Outcome measures
| Measure |
Udenafil 50 mg
n=150 Participants
Udenafil 50 mg tablets
|
Udenafil 100 mg
n=148 Participants
Udenafil 100 mg tablets
|
Udenafil 150mg
n=154 Participants
Udenafil 150mg tablets
|
Placebo
n=153 Participants
Placebo tablets
|
|---|---|---|---|---|
|
Change in SEP Question 4, Change From Baseline to Overall Study/Weeks 1-12, mITT
|
27.36 Percentage of Yes Responders
Interval 21.96 to 32.77
|
32.83 Percentage of Yes Responders
Interval 27.42 to 38.23
|
45.55 Percentage of Yes Responders
Interval 40.24 to 50.86
|
9.30 Percentage of Yes Responders
Interval 3.91 to 14.68
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1 - 12Population: Modified Intent-to-Treat (mITT)
Question 5 SEP: Were you satisfied with this overall sexual experience? yes/no response. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period.
Outcome measures
| Measure |
Udenafil 50 mg
n=150 Participants
Udenafil 50 mg tablets
|
Udenafil 100 mg
n=148 Participants
Udenafil 100 mg tablets
|
Udenafil 150mg
n=154 Participants
Udenafil 150mg tablets
|
Placebo
n=153 Participants
Placebo tablets
|
|---|---|---|---|---|
|
Change in SEP Question 5, Change From Baseline to Overall/Weeks 1-12, mITT
|
26.72 Percentage of Yes Responders
Interval 21.3 to 32.15
|
33.78 Percentage of Yes Responders
Interval 28.36 to 39.2
|
45.52 Percentage of Yes Responders
Interval 40.18 to 50.86
|
8.53 Percentage of Yes Responders
Interval 3.11 to 13.95
|
Adverse Events
Udenafil 50 mg
Udenafil 100 mg
Udenafil 150mg
Placebo
Serious adverse events
| Measure |
Udenafil 50 mg
n=155 participants at risk
Udenafil 50 mg tablets
|
Udenafil 100 mg
n=150 participants at risk
Udenafil 100 mg tablets
|
Udenafil 150mg
n=159 participants at risk
Udenafil 150mg tablets
|
Placebo
n=152 participants at risk
Placebo tablets
|
|---|---|---|---|---|
|
Nervous system disorders
Carotid Artery Disease
|
0.00%
0/155 • 12-week treatment period
|
0.00%
0/150 • 12-week treatment period
|
0.00%
0/159 • 12-week treatment period
|
0.66%
1/152 • Number of events 1 • 12-week treatment period
|
|
Eye disorders
Unilateral Blindness
|
0.00%
0/155 • 12-week treatment period
|
0.00%
0/150 • 12-week treatment period
|
0.00%
0/159 • 12-week treatment period
|
0.66%
1/152 • Number of events 1 • 12-week treatment period
|
|
Eye disorders
Retinal Artery Embolism
|
0.00%
0/155 • 12-week treatment period
|
0.00%
0/150 • 12-week treatment period
|
0.00%
0/159 • 12-week treatment period
|
0.66%
1/152 • Number of events 1 • 12-week treatment period
|
|
Nervous system disorders
Transient Ischemic Attack
|
0.00%
0/155 • 12-week treatment period
|
0.00%
0/150 • 12-week treatment period
|
0.00%
0/159 • 12-week treatment period
|
0.66%
1/152 • Number of events 1 • 12-week treatment period
|
|
Infections and infestations
Pharyngeal Abscess
|
0.00%
0/155 • 12-week treatment period
|
0.00%
0/150 • 12-week treatment period
|
0.00%
0/159 • 12-week treatment period
|
0.66%
1/152 • Number of events 1 • 12-week treatment period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue Neoplasm Malignant Stage Unspecified
|
0.65%
1/155 • Number of events 1 • 12-week treatment period
|
0.00%
0/150 • 12-week treatment period
|
0.00%
0/159 • 12-week treatment period
|
0.00%
0/152 • 12-week treatment period
|
|
Cardiac disorders
Iscemic Cardiomyopathy
|
0.65%
1/155 • Number of events 1 • 12-week treatment period
|
0.00%
0/150 • 12-week treatment period
|
0.00%
0/159 • 12-week treatment period
|
0.00%
0/152 • 12-week treatment period
|
|
Nervous system disorders
Brain Stem Infarction
|
0.00%
0/155 • 12-week treatment period
|
0.67%
1/150 • Number of events 1 • 12-week treatment period
|
0.00%
0/159 • 12-week treatment period
|
0.00%
0/152 • 12-week treatment period
|
|
Skin and subcutaneous tissue disorders
Hypoesthesia Facial
|
0.00%
0/155 • 12-week treatment period
|
0.67%
1/150 • Number of events 1 • 12-week treatment period
|
0.00%
0/159 • 12-week treatment period
|
0.00%
0/152 • 12-week treatment period
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
0.00%
0/155 • 12-week treatment period
|
0.67%
1/150 • Number of events 1 • 12-week treatment period
|
0.00%
0/159 • 12-week treatment period
|
0.00%
0/152 • 12-week treatment period
|
|
Nervous system disorders
Hemorrhagic Cerebral Infarction
|
0.00%
0/155 • 12-week treatment period
|
0.67%
1/150 • Number of events 1 • 12-week treatment period
|
0.00%
0/159 • 12-week treatment period
|
0.00%
0/152 • 12-week treatment period
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/155 • 12-week treatment period
|
0.67%
1/150 • Number of events 1 • 12-week treatment period
|
0.00%
0/159 • 12-week treatment period
|
0.00%
0/152 • 12-week treatment period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm
|
0.00%
0/155 • 12-week treatment period
|
0.67%
1/150 • Number of events 1 • 12-week treatment period
|
0.00%
0/159 • 12-week treatment period
|
0.00%
0/152 • 12-week treatment period
|
|
Endocrine disorders
Goiter
|
0.00%
0/155 • 12-week treatment period
|
0.00%
0/150 • 12-week treatment period
|
0.63%
1/159 • Number of events 1 • 12-week treatment period
|
0.00%
0/152 • 12-week treatment period
|
Other adverse events
| Measure |
Udenafil 50 mg
n=155 participants at risk
Udenafil 50 mg tablets
|
Udenafil 100 mg
n=150 participants at risk
Udenafil 100 mg tablets
|
Udenafil 150mg
n=159 participants at risk
Udenafil 150mg tablets
|
Placebo
n=152 participants at risk
Placebo tablets
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
3.2%
5/155 • 12-week treatment period
|
7.3%
11/150 • 12-week treatment period
|
4.4%
7/159 • 12-week treatment period
|
5.3%
8/152 • 12-week treatment period
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
4.5%
7/155 • 12-week treatment period
|
4.0%
6/150 • 12-week treatment period
|
3.8%
6/159 • 12-week treatment period
|
2.6%
4/152 • 12-week treatment period
|
|
Infections and infestations
Sinusitis
|
1.9%
3/155 • 12-week treatment period
|
2.0%
3/150 • 12-week treatment period
|
2.5%
4/159 • 12-week treatment period
|
2.6%
4/152 • 12-week treatment period
|
|
Infections and infestations
Influenza
|
1.9%
3/155 • 12-week treatment period
|
2.0%
3/150 • 12-week treatment period
|
1.3%
2/159 • 12-week treatment period
|
1.3%
2/152 • 12-week treatment period
|
|
Nervous system disorders
Headache
|
1.3%
2/155 • 12-week treatment period
|
5.3%
8/150 • 12-week treatment period
|
11.9%
19/159 • 12-week treatment period
|
2.6%
4/152 • 12-week treatment period
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
1.3%
2/155 • 12-week treatment period
|
2.0%
3/150 • 12-week treatment period
|
6.9%
11/159 • 12-week treatment period
|
0.00%
0/152 • 12-week treatment period
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
1.3%
2/155 • 12-week treatment period
|
2.0%
3/150 • 12-week treatment period
|
1.3%
2/159 • 12-week treatment period
|
2.6%
4/152 • 12-week treatment period
|
|
Gastrointestinal disorders
Dyspepsia
|
1.9%
3/155 • 12-week treatment period
|
2.7%
4/150 • 12-week treatment period
|
2.5%
4/159 • 12-week treatment period
|
0.66%
1/152 • 12-week treatment period
|
|
Gastrointestinal disorders
Nausea
|
1.9%
3/155 • 12-week treatment period
|
3.3%
5/150 • 12-week treatment period
|
1.3%
2/159 • 12-week treatment period
|
1.3%
2/152 • 12-week treatment period
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
2.6%
4/155 • 12-week treatment period
|
1.3%
2/150 • 12-week treatment period
|
1.3%
2/159 • 12-week treatment period
|
2.6%
4/152 • 12-week treatment period
|
|
Vascular disorders
Flushing
|
3.9%
6/155 • 12-week treatment period
|
3.3%
5/150 • 12-week treatment period
|
6.3%
10/159 • 12-week treatment period
|
0.66%
1/152 • 12-week treatment period
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.9%
3/155 • 12-week treatment period
|
2.7%
4/150 • 12-week treatment period
|
0.63%
1/159 • 12-week treatment period
|
0.66%
1/152 • 12-week treatment period
|
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