Vardenafil Orodispersible Tablet (ODT) Versus Placebo in Males With Erectile Dysfunction, 50% of Whom Are to be 65 Years or Older.

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00655629
• Collaborator: GlaxoSmithKline (Industry), Schering-Plough (Industry)
• Enrollment: 339
• Locations: 40
• Arms: 2
• Duration (Months): 10.1
• Patients Per Site: 8.5
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

This study investigates the safety and efficacy of a new dosage form of Vardenafil, an orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo (inactive) tablet in the treatment of erectile dysfunction. After a 4-week unmedicated phase, patients will receive Vardenafil ODT or matching placebo for 12 weeks. Safety will be determined by laboratory and other evaluations. Efficacy will be determined by the results of different questionnaires and the patient diary that will be used.

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction	Drug: Vardenafil ODT (STAXYN, BAY38-9456); Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 339 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Pivotal Phase III Trial to Investigate the Efficacy and Safety of an Orodispersible Tablet Vardenafil Versus Placebo in the Treatment of Men With Erectile Dysfunction (ED) - a Fixed-dose, Double-blind, Randomized Multi-center Trial
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Feb 1, 2009
• Actual Study Completion Date: Feb 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vardenafil ODT (STAXYN, BAY38-9456) Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.	Drug: Vardenafil ODT (STAXYN, BAY38-9456); Subjects will receive 12 weeks of PRN (on demand) treatment with Vardenafil 10 mg orodispersible tablet (ODT)
Placebo Comparator: Placebo Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.	Drug: Placebo; Subjects will receive 12 weeks of PRN (on demand) treatment with matching placebo tablet

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or Last Observation Carried Forward (LOCF) [from baseline up to 12 weeks]

   The primary variable was the treatment group difference from baseline to Week 12 or LOCF of the least square mean difference in the IIEF-EF domain score (Range: 1-30 ordinal. Directionality: severity of erectile dysfunction: <=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; >25 'no ED'.)

2. Change in Percentage From Baseline in Success of Penetration (SEP2) at 12 Weeks [from baseline up to 12 weeks of treatment]

   SEP (Sexual Encounter Profile) items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to penetrate the partner.

3. Change From Baseline in Success of Erection Maintenance at 12 Weeks [from baseline up to 12 weeks of treatment]

   SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to maintain an erection after penetration.

Secondary Outcome Measures

1. Percentage of Subjects Achieving "Back to Normal" Erectile Function [up to 12 weeks of treatment]

   Responders: percentage of subjects achieving an IIEF-EF score > 25. The primary variable was the treatment group difference from baseline to Week 12 or Last observation carried forward (LOCF) of the least square mean difference in the IIEF-EF domain score (1-30 ordinal points, specifying the severity of erectile dysfunction: <=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; >25 'no ED').

2. Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks [from baseline up to 12 weeks of treatment]

   SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to obtain successful erections.

3. Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks [from baseline up to 12 weeks of treatment]

   SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to get satisfactory hardness of erections.

4. Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks [from baseline up to 12 weeks of treatment]

   SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to overall satisfactory attempts.

5. Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks [from baseline up to 12 weeks of treatment]

   SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to have successful ejaculations.

6. Number of Sexual Attempts Till First Successful Attempt [up to 12 weeks of treatment]

7. Change From Baseline in Ease With Erection at 12 Weeks or LOCF [from baseline up to 12 weeks]

   Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain "Ease with Erection" from baseline to Week 12 or LOCF expressed as the least square mean difference.

8. Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF [from baseline up to 12 weeks]

   Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain "Erectile function satisfaction" from baseline to Week 12 or LOCF expressed as the least square mean difference

9. Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF [from baseline up to 12 weeks]

   Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain "Pleasure of sexual activity" from baseline to Week 12 or LOCF expressed as the least square mean difference

10. Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF [from baseline up to 12 weeks]

    Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain "Satisfaction with orgasm" from baseline to Week 12 or LOCF expressed as the least square mean difference

11. Change From Baseline in Confidence for Completion at 12 Weeks or LOCF [from baseline up to 12 weeks]

    Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain "Confidence for completion" from baseline to Week 12 or LOCF expressed as the least square mean difference

12. Satisfaction With Medication at Week 12 or LOCF [up to 12 weeks]

    Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain "Satisfaction with medication" at LOCF expressed as the least square mean difference

13. Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale [up to 12 weeks of treatment]

    Categorical Rating Scale is a binary rating scale with 2 response options which is 'yes/no'; percentage of participants with positive answers to the Global Assessment Question. Global Assessment Question (GAQ): 'Has the treatment you have been taking over the past for weeks improved your erection?' (yes/no)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Males 18 years-of-age or older.

• Stable, heterosexual relationship for at least 6 months.

• A history of erectile dysfunction (ED) for at least 6 months

Exclusion Criteria:

• Any underlying cardiovascular condition, including unstable angina pectoris

• History of myocardial infarction, stroke or life-threatening arrhythmia within 6 months prior to visit 1

• Uncontrolled atrial fibrillation / flutter at screening

• History of congenital QT prolongation

• History of surgical prostatectomy due to prostate cancer

• Hereditary degenerative retinal disorders

• History of loss of vision because of NAION (Non-arteritic anterior ischemic optic neuropathy), temporary or permanent loss of vision

• Presence of penile anatomical abnormalities

• Spinal cord injury

• Resting or postural hypotension or hypertension

• Subjects who are taking nitrates or nitric oxide donors, androgens, anti-androgens, alpha-blockers, HIV (Human immunodeficiency virus) protease inhibitors, itraconazole or ketoconazole, and clarithromycin and erythromycin.

• Subjects taking medication known to prolong QT interval, such as Type Ia and Type 3 anti-arrhythmics.

• Subjects who have been confirmed with phenylketonuria (PKU).

• Use of any treatment for ED within 7 days of Visit 1.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	East Valley Family Physicians, PLC	Chandler	Arizona	United States	85224
2	Mesa Family Medical Center	Mesa	Arizona	United States	85203
3	Desert Clinical Research	Mesa	Arizona	United States	85213
4	Arizona Research Center, Inc.	Phoenix	Arizona	United States	85023
5	Tatum Highlands Medical Associates, PLLC	Phoenix	Arizona	United States	85050
6	Fiel Family & Sports Medicine, PC	Tempe	Arizona	United States	85283
7	Irvine Center for Clinical Research	Irvine	California	United States	92618-3603
8	Synergy Clinical Research Center	National City	California	United States	91950
9	San Diego Uro-Research	San Diego	California	United States	92103
10	San Diego Clinical Trials	San Diego	California	United States	92120
11	South Florida Medical Research	Aventura	Florida	United States	33180
12	Jacksonville Impotence Treatment Center	Jacksonville	Florida	United States	32223
13	University Clinical Research, Inc.	Pembroke Pines	Florida	United States	33024
14	Tulane Medical Center	New Orleans	Louisiana	United States	70112
15	Office of Dr. Bruce Gilbert, MD	Great Neck	New York	United States	11021
16	Mount Sinai Medical Center	New York	New York	United States	10029
17	The Urology Group	Cincinnati	Ohio	United States	45212-2787
18	Columbus Urology Research, LLC	Columbus	Ohio	United States	43220
19	Family Medical Associates	Levittown	Pennsylvania	United States	19056
20	Pearl Clinical Research	Norristown	Pennsylvania	United States	19401
21	Office of Dr. Roger Fincher, MD	Spokane	Washington	United States	99206
22	Sydney Men's Health	Bondi Junction	New South Wales	Australia	2022
23	Berry Road Medical Centre	St Leonards	New South Wales	Australia	2065
24	South Terrace Urology	Adelaide	South Australia	Australia	5000
25	Cabrini Medical Centre	Melbourne	Victoria	Australia	3144
26	Queen Elizabeth II Medical Centre	Nedlands	Western Australia	Australia	6009
27	Perth Human Sexuality Centre	Perth	Western Australia	Australia	6009
28	St.Joseph's Health Care-London	London	Ontario	Canada	N6A 4V2
29	The Male Health Centres	Oakville	Ontario	Canada	L6H 3P1
30	Office of Dr. Rajiv Singal, MD	Toronto	Ontario	Canada	M4C 5T2
31	Sunnybrook Health Sciences Centre	Toronto	Ontario	Canada	M4N 3M5
32	Clinique d'Urologie du Saguenay	Chicoutimi	Quebec	Canada	G7H 4A3
33	Urology South Shore Research	Greenfield Park	Quebec	Canada	J4V 2H3
34	Centre de Recherche en Sante Sexuelle du Quebec	Montreal	Quebec	Canada	H2X 1N8
35	Sir Mortimer B. Davis Jewish General Hospital	Montreal	Quebec	Canada	H3T 1E2
36	Hospital Dalinde	México, D. F.	Distrito Federal	Mexico	06700
37	Consultorio Dr. Rodríguez Rivera	Guadalajara	Jalisco	Mexico	45040
38	Centro Médico de las Américas	Mérida	Yucatán	Mexico	97001
39	Asociación Mexicana para la Salud Sexual A. C.	México D. F.		Mexico	14000
40	Hospital Santa Fé	México, D. F.		Mexico	06700

Sponsors and Collaborators

• Bayer
• GlaxoSmithKline
• Schering-Plough

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT00655629
• Other Study ID Numbers: 12094
• First Posted: Apr 10, 2008
• Last Update Posted: Aug 1, 2014
• Last Verified: Jul 1, 2014

• Keywords provided by Bayer: Erectile Dysfunction
• Additional relevant MeSH terms: Erectile Dysfunction; Vardenafil Dihydrochloride

Study Results

Participant Flow

Recruitment Details	Subjects recruited to 35 investigational centers in the USA (20), Canada (4), Mexico (5), and Australia (6). First patient first visit on 28 Apr 2008, last patient last visit on 13 Feb 2009.
Pre-assignment Detail	473 subjects screened (<65 years: n=230; >=65 years: n=243), 339 randomized (Vardenafil 10 mg ODT=172, placebo=167). The main efficacy analysis set was the ITT (Intent to Treat) population (randomized treated sub. with baseline and post-baseline in any of the efficacy variables and safety assessment); Vardenafil 10 mg ODT=169, placebo=162

Arm/Group Title	Vardenafil ODT (STAXYN, BAY38-9456)	Placebo
Arm/Group Description	Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.	Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Period Title: Overall Study
STARTED	172	167
Participants Received Treatment	171	166
COMPLETED	151	144
NOT COMPLETED	21	23

Baseline Characteristics

Arm/Group Title	Vardenafil ODT (STAXYN, BAY38-9456)	Placebo	Total
Arm/Group Description	Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.	Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.	Total of all reporting groups
Overall Participants	171	166	337
Age, Customized (participants) [Number]
<65 years	86 50.3%	84 50.6%	170 50.4%
>=65 years	85 49.7%	82 49.4%	167 49.6%
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	171 100%	166 100%	337 100%
Body Mass Index (BMI) (Kilograms per square meter (kg/m^2)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kilograms per square meter (kg/m^2)]	28.9 (4.4)	28.7 (4.2)	28.8 (4.3)

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or Last Observation Carried Forward (LOCF)
Description	The primary variable was the treatment group difference from baseline to Week 12 or LOCF of the least square mean difference in the IIEF-EF domain score (Range: 1-30 ordinal. Directionality: severity of erectile dysfunction: <=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; >25 'no ED'.)
Time Frame	from baseline up to 12 weeks

Outcome Measure Data

Analysis Population Description

The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data

Arm/Group Title	Vardenafil ODT (STAXYN, BAY38-9456)	Placebo
Arm/Group Description	Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.	Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Measure Participants	167	160
<65 years	10.3 (7.78)	1.7 (6.28)
>=65 years	6.7 (8.06)	1.1 (6.01)
Total	8.5 (8.11)	1.4 (6.14)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vardenafil ODT (STAXYN, BAY38-9456), Placebo
	Comments	Power adjustment for 3 primary efficacy variables (3 variables have to be significant in favor of Vardenafil to conclude efficacy). Statistical analysis applies to the total population.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-6.92
	Confidence Interval	() 95%; -8.45 to -5.38
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Change in Percentage From Baseline in Success of Penetration (SEP2) at 12 Weeks
Description	SEP (Sexual Encounter Profile) items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to penetrate the partner.
Time Frame	from baseline up to 12 weeks of treatment

Outcome Measure Data

Analysis Population Description

The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data

Arm/Group Title	Vardenafil ODT (STAXYN, BAY38-9456)	Placebo
Arm/Group Description	Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.	Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Measure Participants	168	161
<65 years	33.2 (33.27)	4.6 (34.12)
>=65 years	27.3 (37.39)	3.0 (33.33)
Total	30.2 (35.40)	3.8 (33.63)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vardenafil ODT (STAXYN, BAY38-9456), Placebo
	Comments	Statistical analysis applies to the total population.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-25.972
	Confidence Interval	() 95%; -32.688 to -19.256
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	Change From Baseline in Success of Erection Maintenance at 12 Weeks
Description	SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to maintain an erection after penetration.
Time Frame	from baseline up to 12 weeks of treatment

Outcome Measure Data

Analysis Population Description

The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data

Arm/Group Title	Vardenafil ODT (STAXYN, BAY38-9456)	Placebo
Arm/Group Description	Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.	Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Measure Participants	168	160
<65 years	53.2 (33.22)	15.2 (29.55)
>=65 years	38.8 (38.32)	8.7 (29.15)
Total	46.0 (36.47)	12.0 (29.44)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vardenafil ODT (STAXYN, BAY38-9456), Placebo
	Comments	Statistical analysis applies to the total population.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-33.432
	Confidence Interval	() 95%; -40.439 to -26.425
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Percentage of Subjects Achieving "Back to Normal" Erectile Function
Description	Responders: percentage of subjects achieving an IIEF-EF score > 25. The primary variable was the treatment group difference from baseline to Week 12 or Last observation carried forward (LOCF) of the least square mean difference in the IIEF-EF domain score (1-30 ordinal points, specifying the severity of erectile dysfunction: <=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; >25 'no ED').
Time Frame	up to 12 weeks of treatment

Outcome Measure Data

Analysis Population Description

The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data

Arm/Group Title	Vardenafil ODT (STAXYN, BAY38-9456)	Placebo
Arm/Group Description	Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.	Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Measure Participants	167	160
<65 years	59	11
>=65 years	32	8
Total	46	9

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vardenafil ODT (STAXYN, BAY38-9456), Placebo
	Comments	Statistical analysis applies to the total population.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	CMH adjusted for age group and center
Method of Estimation	Estimation Parameter	Cochran-Mantel-Haenszel
	Estimated Value	53.8693
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks
Description	SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to obtain successful erections.
Time Frame	from baseline up to 12 weeks of treatment

Outcome Measure Data

Analysis Population Description

The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data

Arm/Group Title	Vardenafil ODT (STAXYN, BAY38-9456)	Placebo
Arm/Group Description	Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.	Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Measure Participants	168	161
<65 years	13.4 (28.63)	-5.8 (38.18)
>=65 years	9.6 (35.96)	-3.8 (37.04)
Total	11.5 (32.46)	-4.8 (37.51)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vardenafil ODT (STAXYN, BAY38-9456), Placebo
	Comments	Statistical analysis applies to the total population.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-16.078
	Confidence Interval	() 95%; -22.41 to -9.746
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks
Description	SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to get satisfactory hardness of erections.
Time Frame	from baseline up to 12 weeks of treatment

Outcome Measure Data

Analysis Population Description

The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data

Arm/Group Title	Vardenafil ODT (STAXYN, BAY38-9456)	Placebo
Arm/Group Description	Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.	Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Measure Participants	168	160
<65 years	52.0 (40.04)	12.2 (30.89)
>=65 years	36.1 (41.54)	5.4 (31.21)
Total	44.1 (41.45)	8.8 (31.14)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vardenafil ODT (STAXYN, BAY38-9456), Placebo
	Comments	Statistical analysis applies to the total population.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-33.134
	Confidence Interval	() 95%; -40.281 to -25.987
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks
Description	SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to overall satisfactory attempts.
Time Frame	from baseline up to 12 weeks of treatment

Outcome Measure Data

Analysis Population Description

The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data

Arm/Group Title	Vardenafil ODT (STAXYN, BAY38-9456)	Placebo
Arm/Group Description	Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.	Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Measure Participants	168	160
<65 years	52.0 (40.04)	12.2 (30.89)
>=65 years	38.4 (38.43)	10.3 (26.70)
Total	45.1 (40.15)	11.2 (26.39)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vardenafil ODT (STAXYN, BAY38-9456), Placebo
	Comments	Statistical analysis applies to the total population.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-33.934
	Confidence Interval	() 95%; -41.119 to -26.749
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks
Description	SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to have successful ejaculations.
Time Frame	from baseline up to 12 weeks of treatment

Outcome Measure Data

Analysis Population Description

The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data

Arm/Group Title	Vardenafil ODT (STAXYN, BAY38-9456)	Placebo
Arm/Group Description	Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.	Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Measure Participants	168	160
<65 years	37.3 (32.52)	7.1 (35.0)
>=65 years	17.7 (36.27)	2.7 (36.51)
Total	27.5 (35.72)	4.9 (35.71)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vardenafil ODT (STAXYN, BAY38-9456), Placebo
	Comments	Statistical analysis applies to the total population.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-20.902
	Confidence Interval	() 95%; -27.724 to -14.081
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

Title	Number of Sexual Attempts Till First Successful Attempt
Time Frame	up to 12 weeks of treatment

Outcome Measure Data

Analysis Population Description

The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data

Arm/Group Title	Vardenafil ODT (STAXYN, BAY38-9456)	Placebo
Arm/Group Description	Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.	Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Measure Participants	134	92
<65 years	1.2 (3.7)	2.6 (3.5)
>=65 years	1.6 (4.5)	3.8 (3.9)
Total	1.4 (4.1)	3.1 (3.7)

10. Secondary Outcome

Title	Change From Baseline in Ease With Erection at 12 Weeks or LOCF
Description	Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain "Ease with Erection" from baseline to Week 12 or LOCF expressed as the least square mean difference.
Time Frame	from baseline up to 12 weeks

Outcome Measure Data

Analysis Population Description

The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data

Arm/Group Title	Vardenafil ODT (STAXYN, BAY38-9456)	Placebo
Arm/Group Description	Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.	Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Measure Participants	158	158
<65 years	24.0 (34.29)	6.1 (31.77)
>=65 years	14.4 (29.17)	0.0 (27.84)
Total	19.1 (32.07)	3.0 (29.91)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vardenafil ODT (STAXYN, BAY38-9456), Placebo
	Comments	Statistical analysis applies to the total population.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-16.866
	Confidence Interval	() 95%; -22.599 to -11.133
	Parameter Dispersion	Type: Value:
	Estimation Comments

11. Secondary Outcome

Title	Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF
Description	Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain "Erectile function satisfaction" from baseline to Week 12 or LOCF expressed as the least square mean difference
Time Frame	from baseline up to 12 weeks

Outcome Measure Data

Analysis Population Description

The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data

Arm/Group Title	Vardenafil ODT (STAXYN, BAY38-9456)	Placebo
Arm/Group Description	Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.	Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Measure Participants	158	158
<65 years	41.2 (27.78)	7.6 (24.95)
>=65 years	25.4 (26.11)	4.2 (24.84)
Total	33.2 (28.01)	5.9 (24.88)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vardenafil ODT (STAXYN, BAY38-9456), Placebo
	Comments	Statistical analysis applies to the total population.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-26.040
	Confidence Interval	() 95%; -31.547 to -20.533
	Parameter Dispersion	Type: Value:
	Estimation Comments

12. Secondary Outcome

Title	Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF
Description	Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain "Pleasure of sexual activity" from baseline to Week 12 or LOCF expressed as the least square mean difference
Time Frame	from baseline up to 12 weeks

Outcome Measure Data

Analysis Population Description

The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data

Arm/Group Title	Vardenafil ODT (STAXYN, BAY38-9456)	Placebo
Arm/Group Description	Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.	Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Measure Participants	158	158
<65 years	30.1 (24.63)	4.8 (25.82)
>=65 years	15.3 (29.63)	-1.9 (22.42)
Total	22.6 (28.19)	1.4 (24.31)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vardenafil ODT (STAXYN, BAY38-9456), Placebo
	Comments	Statistical analysis applies to the total population.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-19.496
	Confidence Interval	() 95%; -24.676 to -14.315
	Parameter Dispersion	Type: Value:
	Estimation Comments

13. Secondary Outcome

Title	Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF
Description	Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain "Satisfaction with orgasm" from baseline to Week 12 or LOCF expressed as the least square mean difference
Time Frame	from baseline up to 12 weeks

Outcome Measure Data

Analysis Population Description

The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data

Arm/Group Title	Vardenafil ODT (STAXYN, BAY38-9456)	Placebo
Arm/Group Description	Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.	Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Measure Participants	158	157
Mean (Standard Deviation) [scores on a scale]	23.6 (30.81)	3.2 (31.36)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vardenafil ODT (STAXYN, BAY38-9456), Placebo
	Comments	Statistical analysis applies to the total population.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-18.418
	Confidence Interval	() 95%; -24.439 to -12.396
	Parameter Dispersion	Type: Value:
	Estimation Comments

14. Secondary Outcome

Title	Change From Baseline in Confidence for Completion at 12 Weeks or LOCF
Description	Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain "Confidence for completion" from baseline to Week 12 or LOCF expressed as the least square mean difference
Time Frame	from baseline up to 12 weeks

Outcome Measure Data

Analysis Population Description

The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data

Arm/Group Title	Vardenafil ODT (STAXYN, BAY38-9456)	Placebo
Arm/Group Description	Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.	Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Measure Participants	158	158
<65 years	38.0 (28.59)	4.8 (28.22)
>=65 years	20.2 (27.74)	2.8 (27.05)
Total	29.0 (29.46)	3.8 (27.56)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vardenafil ODT (STAXYN, BAY38-9456), Placebo
	Comments	Statistical analysis applies to the total population.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-22.379
	Confidence Interval	() 95%; -28.006 to -16.753
	Parameter Dispersion	Type: Value:
	Estimation Comments

15. Secondary Outcome

Title	Satisfaction With Medication at Week 12 or LOCF
Description	Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain "Satisfaction with medication" at LOCF expressed as the least square mean difference
Time Frame	up to 12 weeks

Outcome Measure Data

Analysis Population Description

The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with LOCF values.

Arm/Group Title	Vardenafil ODT (STAXYN, BAY38-9456)	Placebo
Arm/Group Description	Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.	Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Measure Participants	159	158
<65 years	58.6 (26.55)	19.3 (26.55)
>=65 years	42.5 (30.26)	20.2 (24.59)
Total	50.5 (29.52)	19.7 (25.50)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vardenafil ODT (STAXYN, BAY38-9456), Placebo
	Comments	Statistical analysis applies to the total population.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-30.758
	Confidence Interval	() 95%; -36.736 to -24.779
	Parameter Dispersion	Type: Value:
	Estimation Comments

16. Secondary Outcome

Title	Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale
Description	Categorical Rating Scale is a binary rating scale with 2 response options which is 'yes/no'; percentage of participants with positive answers to the Global Assessment Question. Global Assessment Question (GAQ): 'Has the treatment you have been taking over the past for weeks improved your erection?' (yes/no)
Time Frame	up to 12 weeks of treatment

Outcome Measure Data

Analysis Population Description

The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data

Arm/Group Title	Vardenafil ODT (STAXYN, BAY38-9456)	Placebo
Arm/Group Description	Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.	Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Measure Participants	160	157
<65 years	75 43.9%	19 11.4%
>=65 years	59 34.5%	28 16.9%
Total	67 39.2%	24 14.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vardenafil ODT (STAXYN, BAY38-9456), Placebo
	Comments	Statistical analysis applies to the total population.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	CMH adjusted for age group and center
Method of Estimation	Estimation Parameter	Cochran-Mantel-Haenszel
	Estimated Value	60.2391
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Arm/Group Title	Vardenafil ODT (STAXYN, BAY38-9456)		Placebo
Arm/Group Description	Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.		Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
All Cause Mortality
	Vardenafil ODT (STAXYN, BAY38-9456)		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Vardenafil ODT (STAXYN, BAY38-9456)		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/171 (1.2%)		1/166 (0.6%)
Cardiac disorders
Arrhythmia	1/171 (0.6%)		0/166 (0%)
General disorders
Chest pain	1/171 (0.6%)		0/166 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer	0/171 (0%)		1/166 (0.6%)
Vascular disorders
Hypertension	1/171 (0.6%)		0/166 (0%)
Other (Not Including Serious) Adverse Events
	Vardenafil ODT (STAXYN, BAY38-9456)		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	65/171 (38%)		37/166 (22.3%)
Cardiac disorders
Bundle branch block	1/171 (0.6%)		0/166 (0%)
Bundle branch block right	0/171 (0%)		1/166 (0.6%)
Mitral valve incompetence	1/171 (0.6%)		0/166 (0%)
Supraventricular extrasystoles	1/171 (0.6%)		1/166 (0.6%)
Tricuspid valve incompetence	1/171 (0.6%)		0/166 (0%)
Ventricular extrasystoles	2/171 (1.2%)		2/166 (1.2%)
Left ventricular hypertrophy	1/171 (0.6%)		0/166 (0%)
Ear and labyrinth disorders
Vertigo	1/171 (0.6%)		0/166 (0%)
Eye disorders
Diplopia	1/171 (0.6%)		0/166 (0%)
Eye pain	1/171 (0.6%)		0/166 (0%)
Vision blurred	1/171 (0.6%)		1/166 (0.6%)
Eye pruritus	1/171 (0.6%)		0/166 (0%)
Gastrointestinal disorders
Abdominal pain	0/171 (0%)		1/166 (0.6%)
Abdominal pain upper	1/171 (0.6%)		0/166 (0%)
Colonic polyp	0/171 (0%)		1/166 (0.6%)
Constipation	0/171 (0%)		1/166 (0.6%)
Diarrhoea	3/171 (1.8%)		1/166 (0.6%)
Dry mouth	2/171 (1.2%)		1/166 (0.6%)
Dyspepsia	3/171 (1.8%)		0/166 (0%)
Dysphagia	1/171 (0.6%)		0/166 (0%)
Nausea	1/171 (0.6%)		0/166 (0%)
Toothache	1/171 (0.6%)		0/166 (0%)
General disorders
Chest discomfort	1/171 (0.6%)		0/166 (0%)
Chest pain	2/171 (1.2%)		0/166 (0%)
Fatigue	1/171 (0.6%)		0/166 (0%)
Feeling hot	1/171 (0.6%)		0/166 (0%)
Pyrexia	1/171 (0.6%)		0/166 (0%)
Infections and infestations
Influenza	1/171 (0.6%)		0/166 (0%)
Nasopharyngitis	0/171 (0%)		3/166 (1.8%)
Pharyngitis	3/171 (1.8%)		3/166 (1.8%)
Pharyngitis streptococcal	0/171 (0%)		1/166 (0.6%)
Pneumonia	1/171 (0.6%)		0/166 (0%)
Rhinitis	2/171 (1.2%)		0/166 (0%)
Sinusitis	1/171 (0.6%)		2/166 (1.2%)
Tooth abscess	0/171 (0%)		2/166 (1.2%)
Upper respiratory tract infection	3/171 (1.8%)		0/166 (0%)
Urinary tract infection	1/171 (0.6%)		0/166 (0%)
Bacterial rhinitis	1/171 (0.6%)		0/166 (0%)
Injury, poisoning and procedural complications
Arthropod sting	0/171 (0%)		1/166 (0.6%)
Multiple injuries	1/171 (0.6%)		0/166 (0%)
Muscle injury	1/171 (0.6%)		0/166 (0%)
Contusion	1/171 (0.6%)		0/166 (0%)
Penis deviation	1/171 (0.6%)		0/166 (0%)
Investigations
Arthroscopy	0/171 (0%)		1/166 (0.6%)
Blood creatinine increased	1/171 (0.6%)		0/166 (0%)
Blood pressure increased	2/171 (1.2%)		0/166 (0%)
Cardiac murmur	1/171 (0.6%)		0/166 (0%)
Heart rate increased	1/171 (0.6%)		0/166 (0%)
Metabolism and nutrition disorders
Diabetes mellitus	1/171 (0.6%)		1/166 (0.6%)
Gout	1/171 (0.6%)		0/166 (0%)
Hypertriglyceridaemia	1/171 (0.6%)		0/166 (0%)
Hyperlipidaemia	1/171 (0.6%)		0/166 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/171 (0.6%)		1/166 (0.6%)
Back pain	4/171 (2.3%)		1/166 (0.6%)
Joint swelling	1/171 (0.6%)		0/166 (0%)
Muscle spasms	2/171 (1.2%)		0/166 (0%)
Musculoskeletal pain	1/171 (0.6%)		1/166 (0.6%)
Myalgia	1/171 (0.6%)		0/166 (0%)
Neck pain	2/171 (1.2%)		0/166 (0%)
Pain in extremity	1/171 (0.6%)		0/166 (0%)
Spinal osteoarthritis	1/171 (0.6%)		0/166 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma	0/171 (0%)		1/166 (0.6%)
Nervous system disorders
Burning sensation	1/171 (0.6%)		0/166 (0%)
Dizziness	5/171 (2.9%)		0/166 (0%)
Headache	21/171 (12.3%)		4/166 (2.4%)
Sinus headache	1/171 (0.6%)		0/166 (0%)
Psychiatric disorders
Anxiety	0/171 (0%)		1/166 (0.6%)
Reproductive system and breast disorders
Prostatitis	0/171 (0%)		1/166 (0.6%)
Testicular pain	0/171 (0%)		1/166 (0.6%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	1/171 (0.6%)		0/166 (0%)
Cough	2/171 (1.2%)		0/166 (0%)
Dyspnoea	2/171 (1.2%)		0/166 (0%)
Nasal congestion	8/171 (4.7%)		1/166 (0.6%)
Rhinorrhoea	1/171 (0.6%)		0/166 (0%)
Sleep apnoea syndrome	0/171 (0%)		1/166 (0.6%)
Wheezing	1/171 (0.6%)		0/166 (0%)
Oropharyngeal pain	0/171 (0%)		1/166 (0.6%)
Skin and subcutaneous tissue disorders
Hyperhidrosis	1/171 (0.6%)		0/166 (0%)
Ingrowing nail	0/171 (0%)		1/166 (0.6%)
Night sweats	1/171 (0.6%)		0/166 (0%)
Rash	2/171 (1.2%)		2/166 (1.2%)
Social circumstances
Pharmaceutical product complaint	0/171 (0%)		1/166 (0.6%)
Surgical and medical procedures
Skin lesion excision	0/171 (0%)		1/166 (0.6%)
Cataract operation	1/171 (0.6%)		0/166 (0%)
Vascular disorders
Flushing	13/171 (7.6%)		2/166 (1.2%)
Hypertension	1/171 (0.6%)		2/166 (1.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

In the protocol it is specified that all results are the property of the sponsor. The investigator must discuss any publication with the sponsor prior to release and obtain written consent of the sponsor. The investigator must send a draft publication to the sponsor thirty days in advance of submission in order to obtain approval prior to submission of the final version for publication.