A Study for Patients With Erectile Dysfunction to Test Whether Tadalafil Taken Once a Day Can Better Improve Psychological Outcomes.

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00734604
• Collaborator: (none)
• Enrollment: 378
• Locations: 37
• Arms: 6
• Duration (Months): 13
• Patients Per Site: 10.2
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

The primary purpose of the study is to help answer whether tadalafil taken once a day can help improve the psychological outcomes (such as sexual self confidence, spontaneity and time concerns) compared to sildenafil taken as needed in patients with erectile dysfunction (ED).

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction	Drug: tadalafil once a day [T(OaD)]; Drug: sildenafil citrate as needed [S(PRN)]; Drug: tadalafil as needed [T(PRN)]	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 378 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Comparison of Psychosocial Outcomes Following Tadalafil Once a Day or PDE5 Inhibitor As Needed in Men With Erectile Dysfunction.
• Study Start Date: Aug 1, 2008
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: T(OaD)/S(PRN)/T(PRN) Tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks	Drug: tadalafil once a day [T(OaD)]; 5 mg tablet taken once a day (OaD) by mouth for 8 weeks; Other Names: Cialis LY450190 ; Drug: sildenafil citrate as needed [S(PRN)]; 100 mg tablet taken as needed (PRN) by mouth for 8 weeks; Drug: tadalafil as needed [T(PRN)]; 20 mg tablet taken as needed (PRN) by mouth for 8 weeks; Other Names: Cialis LY450190
Experimental: T(OaD)/T(PRN)/S(PRN) Tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks	Drug: tadalafil once a day [T(OaD)]; 5 mg tablet taken once a day (OaD) by mouth for 8 weeks; Other Names: Cialis LY450190 ; Drug: sildenafil citrate as needed [S(PRN)]; 100 mg tablet taken as needed (PRN) by mouth for 8 weeks; Drug: tadalafil as needed [T(PRN)]; 20 mg tablet taken as needed (PRN) by mouth for 8 weeks; Other Names: Cialis LY450190
Experimental: S(PRN)/T(OaD)/T(PRN) Sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks	Drug: tadalafil once a day [T(OaD)]; 5 mg tablet taken once a day (OaD) by mouth for 8 weeks; Other Names: Cialis LY450190 ; Drug: sildenafil citrate as needed [S(PRN)]; 100 mg tablet taken as needed (PRN) by mouth for 8 weeks; Drug: tadalafil as needed [T(PRN)]; 20 mg tablet taken as needed (PRN) by mouth for 8 weeks; Other Names: Cialis LY450190
Experimental: S(PRN)/T(PRN)/T(OaD) Sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks	Drug: tadalafil once a day [T(OaD)]; 5 mg tablet taken once a day (OaD) by mouth for 8 weeks; Other Names: Cialis LY450190 ; Drug: sildenafil citrate as needed [S(PRN)]; 100 mg tablet taken as needed (PRN) by mouth for 8 weeks; Drug: tadalafil as needed [T(PRN)]; 20 mg tablet taken as needed (PRN) by mouth for 8 weeks; Other Names: Cialis LY450190
Experimental: T(PRN)/T(OaD)/S(PRN) Tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks	Drug: tadalafil once a day [T(OaD)]; 5 mg tablet taken once a day (OaD) by mouth for 8 weeks; Other Names: Cialis LY450190 ; Drug: sildenafil citrate as needed [S(PRN)]; 100 mg tablet taken as needed (PRN) by mouth for 8 weeks; Drug: tadalafil as needed [T(PRN)]; 20 mg tablet taken as needed (PRN) by mouth for 8 weeks; Other Names: Cialis LY450190
Experimental: T(PRN)/S(PRN)/T(OaD) Tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks	Drug: tadalafil once a day [T(OaD)]; 5 mg tablet taken once a day (OaD) by mouth for 8 weeks; Other Names: Cialis LY450190 ; Drug: sildenafil citrate as needed [S(PRN)]; 100 mg tablet taken as needed (PRN) by mouth for 8 weeks; Drug: tadalafil as needed [T(PRN)]; 20 mg tablet taken as needed (PRN) by mouth for 8 weeks; Other Names: Cialis LY450190

Outcome Measures

Primary Outcome Measures

1. Change From Baseline Between Tadalafil Once a Day (OaD) and Sildenafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS) [baseline, 8 weeks of each treatment]

   The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Sexual Self-Confidence score is the average of responses on 6 PAIRS item scores. Sexual Self-Confidence scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence.

Secondary Outcome Measures

1. Change From Baseline Between Tadalafil Once a Day (OaD) and Tadalafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS) [baseline, 8 weeks of each treatment]

   The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Sexual Self-Confidence score is the average of responses on 6 PAIRS item scores. Sexual Self-Confidence scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence.

2. Change From Baseline to Endpoint in the Spontaneity Domain of PAIRS [baseline, 8 weeks of each treatment]

   The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Spontaneity score is the average of responses on 9 PAIRS item scores. Spontaneity scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater spontaneity.

3. Change From Baseline to Endpoint in the Time Concerns Domain of PAIRS [baseline, 8 weeks of each treatment]

   The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Time Concerns score is the average of responses on 8 PAIRS item scores. Time Concerns scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence.

4. Change From Baseline to Endpoint in the Erectile Function Domain of the International Index of Erectile Function (IIEF) [baseline, 8 weeks of each treatment]

   Self-reported erectile function over the past 4 weeks. Scores range from 0 (low or no erectile function) to 5 (high erectile function) on 6 questions (1-5, 15 of the IIEF). Total Erectile Function Domain scores range from 0 to 30.

5. Change From Baseline to Endpoint in the Proportion of Days With at Least One Morning Erection [baseline, 8 weeks of each treatment]

6. Change From Baseline to Endpoint in the Intercourse Satisfaction (IS) Domain of the IIEF [baseline, 8 weeks of each treatment]

   Self-reported intercourse satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 3 questions of the IIEF-IS domain range from 0 to 15.

7. Change From Baseline to Endpoint in the Overall Satisfaction (OS) Domain of the IIEF [baseline, 8 weeks of each treatment]

   Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-OS domain range from 0 to 10.

8. Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Score at Endpoint [8 weeks of each treatment]

   EDITS is a questionnaire-based inventory capturing a participant's subjective evaluation of treatment for the participant's erection problems. All items on the 11-item Patient EDITS were scored from zero (no satisfaction or dissatisfaction) to four (high satisfaction). The EDITS Summary Score (transformed) is obtained by adding each individual score for all questions, dividing by the number of questions, and multiplying by 25, so that EDITS scores could range from a low of 0 (extremely low treatment satisfaction) to a high of 100 (extremely high treatment satisfaction).

9. Number of Participants With at Least One Serious Adverse Event [baseline through 26 weeks (including two washout periods of 1 week each)]

   Serious adverse events are listed in the Reported Adverse Event module.

10. Change From Baseline to Endpoint in the Self-Esteem And Relationship (SEAR) Questionnaire Transformed Total Score [baseline, 8 weeks of each treatment]

    Measures improvement in self-esteem and relationship satisfaction. Questionnaire consists of two domains, Sexual Relationship (items 1-8) and Confidence (items 9-14). Overall score is transformed onto a 0 (least favorable) to 100 (most favorable) scale. Overall score was calculated from two domains and subscales scores.

11. Question 1 "I Felt as if I Did Not Have ED" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint [8 weeks of each treatment]

    Scores for Question 1 range from 0 (not at all) to 4 (extremely).

12. Question 2 "I Felt in Control of my Sex Life" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint [8 weeks of each treatment]

    Scores for Question 2 range from 0 (not at all) to 4 (extremely).

13. Question 3 "I Felt the Drug Was in Control of my Erections" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint [8 weeks of each treatment]

    Scores for Question 3 range from 0 (not at all) to 4 (extremely).

14. Question 4 "I Felt Like a Whole Man" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint [8 weeks of each treatment]

    Scores for Question 4 range from 0 (not at all) to 4 (extremely).

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• History of erectile dysfunction (ED).

• Have had satisfactory response to tadalafil, sildenafil citrate, or vardenafil HCl for a period of at least 6 months and expect frequent use (at least one dose per week, on average) when administered as needed.

• Have never used tadalafil 5 mg or 2.5 mg once a day therapy.

• Anticipate having the same adult female sexual partner willing to participate during the study.

• Agree to make at least four sexual intercourse attempts during the first four weeks of the study.

• Agree not to use any other treatment for ED (even herbal treatments) during the study.

• Agree to follow the directions given by the study doctor and staff about using the study drug.

Exclusion Criteria:

• Have any other primary sexual disorders present or penile deformity.

• Have history of radical prostatectomy or penile implant.

• Have problems with your kidneys, liver, or nervous system.

• Have uncontrolled diabetes, as measured by a blood test for haemoglobin A1C greater than a value of 11%.

• Are being treated for heart disease with any drug that is called a nitrate (for example, nitroglycerin).

• Have chest pain (called unstable angina or angina) that requires treatment.

• Have heart disease that causes symptoms after you exert yourself.

• Have had any of the following in the past 90 days: Heart attack, also known as a myocardial infarction (MI); Heart bypass surgery (called coronary artery bypass graft surgery); Had a procedure to open up blood vessels in the heart known as angioplasty or stent placement (percutaneous coronary intervention).

• Have a history of loss of vision in one eye because of nonarteritic anterior ischemic optic neuropathy (NAION).

• Have retinitis pigmentosa.

• Have history of human immunodeficiency virus (HIV).

• Have very high or very low blood pressure (your study doctor will discuss the limits with you).

• Have had a stroke or a significant injury to your brain or spinal cord within the last 6 months.

• Have rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption Lactose intolerance.

• Have a scheduled or planned surgery requiring anaesthesia during the course of the study.

• Have a scheduled cataract surgery during the curse of the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Huntsville	Alabama	United States	35801
2	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Newport Beach	California	United States	92660
3	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Middlebury	Connecticut	United States	06762
4	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Plantation	Florida	United States	33317
5	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Knoxville	Tennessee	United States	37920
6	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	San Antonio	Texas	United States	78229
7	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Federal Way	Washington	United States	98003
8	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Adelaide	South Australia	Australia	5000
9	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Malvern	Victoria	Australia	3144
10	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Nedlands	Western Australia	Australia	6009
11	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Goiânia		Brazil	74110-020
12	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Rio Claro		Brazil	13500-020
13	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Rio De Janeiro		Brazil	20725-090
14	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Sao Jose Rio Preto		Brazil	15090-000
15	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Sao Paulo		Brazil	04044-060
16	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Augsburg		Germany	86150
17	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Berlin		Germany	13465
18	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Hamburg		Germany	20354
19	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Milan		Italy	20132
20	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Sassari		Italy	07100
21	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Torino		Italy	10126
22	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	La Joya		Mexico	14000
23	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Mexico City		Mexico	10700
24	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Monterrey		Mexico	64040
25	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	San Juan		Puerto Rico	00912
26	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Santurce		Puerto Rico	00907
27	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Barcelona		Spain	08025
28	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	La Coruña		Spain	15006
29	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Madrid		Spain	28040
30	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Malaga		Spain	29007
31	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Sevilla		Spain	41013
32	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Vigo		Spain	36211
33	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Durham	County Durham	United Kingdom	DH1 2QW
34	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Plymouth	Devonshire	United Kingdom	PL6 8BX
35	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Lichfield	Staffordshire	United Kingdom	WS14 9JL
36	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Leeds	West Yorkshire	United Kingdom	LS9 7TF
37	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	London		United Kingdom	NW8 9NH

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Easter Time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00734604
• Other Study ID Numbers: 12313; H6D-CR-S024
• First Posted: Aug 14, 2008
• Last Update Posted: Nov 18, 2010
• Last Verified: Oct 1, 2010

• Additional relevant MeSH terms: Erectile Dysfunction; Sildenafil Citrate; Tadalafil

Study Results

Participant Flow

Arm/Group Title	T(OaD)/S(PRN)/T(PRN)	T(OaD)/T(PRN)/S(PRN)	S(PRN)/T(OaD)/T(PRN)	S(PRN)/T(PRN)/T(OaD)	T(PRN)/T(OaD)/S(PRN)	T(PRN)/S(PRN)/T(OaD)
Arm/Group Description	Tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks	Tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks	Sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks	Sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks	Tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks	Tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks
Period Title: Overall Study
STARTED	62	63	63	63	63	64
COMPLETED	59	51	57	54	55	58
NOT COMPLETED	3	12	6	9	8	6

Baseline Characteristics

Arm/Group Title	T(OaD)/S(PRN)/T(PRN)	T(OaD)/T(PRN)/S(PRN)	S(PRN)/T(OaD)/T(PRN)	S(PRN)/T(PRN)/T(OaD)	T(PRN)/T(OaD)/S(PRN)	T(PRN)/S(PRN)/T(OaD)	Total
Arm/Group Description	Tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks	Tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks	Sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks	Sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks	Tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks	Tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks	Total of all reporting groups
Overall Participants	62	63	63	63	63	64	378
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.53 (11.62)	55.12 (8.89)	55.40 (11.70)	54.87 (12.04)	59.04 (10.56)	54.36 (10.28)	56.21 (10.98)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Male	62 100%	63 100%	63 100%	63 100%	63 100%	64 100%	378 100%
Race/Ethnicity, Customized (participants) [Number]
African	1 1.6%	1 1.6%	1 1.6%	4 6.3%	3 4.8%	2 3.1%	12 3.2%
Caucasian	41 66.1%	44 69.8%	46 73%	41 65.1%	43 68.3%	40 62.5%	255 67.5%
East Asian	1 1.6%	0 0%	1 1.6%	0 0%	0 0%	1 1.6%	3 0.8%
Hispanic	19 30.6%	17 27%	15 23.8%	18 28.6%	17 27%	19 29.7%	105 27.8%
Native American	0 0%	0 0%	0 0%	0 0%	0 0%	2 3.1%	2 0.5%
West Asian	0 0%	1 1.6%	0 0%	0 0%	0 0%	0 0%	1 0.3%
Region of Enrollment (participants) [Number]
Australia	3 4.8%	4 6.3%	5 7.9%	4 6.3%	4 6.3%	4 6.3%	24 6.3%
Germany	7 11.3%	6 9.5%	6 9.5%	7 11.1%	7 11.1%	7 10.9%	40 10.6%
Italy	5 8.1%	5 7.9%	4 6.3%	6 9.5%	4 6.3%	5 7.8%	29 7.7%
Mexico	14 22.6%	14 22.2%	14 22.2%	14 22.2%	14 22.2%	14 21.9%	84 22.2%
Spain	10 16.1%	10 15.9%	10 15.9%	9 14.3%	9 14.3%	9 14.1%	57 15.1%
United Kingdom	6 9.7%	8 12.7%	7 11.1%	7 11.1%	8 12.7%	8 12.5%	44 11.6%
United States	17 27.4%	16 25.4%	17 27%	16 25.4%	17 27%	17 26.6%	100 26.5%
Body Mass Index (BMI) (kilograms per square meter (kg/m^2)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilograms per square meter (kg/m^2)]	28.35 (4.18)	27.62 (2.65)	27.77 (3.71)	28.68 (4.74)	27.80 (3.51)	29.08 (4.26)	28.22 (3.91)
Erectile Dysfunction (ED) Duration (participants) [Number]
=> 1 year	59 95.2%	61 96.8%	58 92.1%	58 92.1%	61 96.8%	59 92.2%	356 94.2%
=> than 6 months through <1 year	3 4.8%	2 3.2%	5 7.9%	5 7.9%	2 3.2%	5 7.8%	22 5.8%
ED Etiology (participants) [Number]
Mixed	25 40.3%	26 41.3%	21 33.3%	23 36.5%	23 36.5%	28 43.8%	146 38.6%
Organic	22 35.5%	28 44.4%	29 46%	29 46%	30 47.6%	25 39.1%	163 43.1%
Psychogenic	5 8.1%	3 4.8%	9 14.3%	9 14.3%	1 1.6%	7 10.9%	34 9%
Unknown	10 16.1%	6 9.5%	4 6.3%	2 3.2%	9 14.3%	4 6.3%	35 9.3%
Prior sildenafil citrate use as needed (PRN) (participants) [Number]
Yes	36 58.1%	40 63.5%	40 63.5%	39 61.9%	39 61.9%	35 54.7%	229 60.6%
No	26 41.9%	23 36.5%	23 36.5%	24 38.1%	24 38.1%	29 45.3%	149 39.4%
Prior Vardenafil HCl use (participants) [Number]
Yes	21 33.9%	18 28.6%	17 27%	10 15.9%	19 30.2%	19 29.7%	104 27.5%
No	41 66.1%	45 71.4%	46 73%	53 84.1%	44 69.8%	45 70.3%	274 72.5%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline Between Tadalafil Once a Day (OaD) and Sildenafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS)
Description	The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Sexual Self-Confidence score is the average of responses on 6 PAIRS item scores. Sexual Self-Confidence scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence.
Time Frame	baseline, 8 weeks of each treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tadalafil Once a Day [T(OaD)]	Sildenafil as Needed [S(PRN)]
Arm/Group Description	Tadalafil 5 mg once a day [T(OaD)]	Sildenafil citrate 100 mg as needed [S(PRN)]
Measure Participants	351	347
Baseline	2.24 (0.62)	2.23 (0.63)
Change from Baseline	0.50 (0.78)	0.39 (0.67)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tadalafil Once a Day [T(OaD)], Sildenafil as Needed [S(PRN)]
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments	p-value is for difference in LS Means change from baseline between tadalafil OaD and Sildenafil PRN.
	Method	t-test
	Comments	Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.12
	Confidence Interval	(2-Sided) 95%; 0.04 to 0.19
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.04
	Estimation Comments

2. Secondary Outcome

Title	Change From Baseline Between Tadalafil Once a Day (OaD) and Tadalafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS)
Description	The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Sexual Self-Confidence score is the average of responses on 6 PAIRS item scores. Sexual Self-Confidence scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence.
Time Frame	baseline, 8 weeks of each treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tadalafil Once a Day [T(OaD)]	Tadalafil as Needed [T(PRN)]
Arm/Group Description	Tadalafil 5 mg once a day [T(OaD)]	Tadalafil 20 mg as needed [T(PRN)]
Measure Participants	351	354
Baseline	2.24 (0.62)	2.24 (0.63)
Change from Baseline	0.50 (0.78)	0.50 (0.72)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tadalafil Once a Day [T(OaD)], Sildenafil as Needed [S(PRN)]
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.872
	Comments	p-value is for difference in Pairs Sexual Self-Confidence Domain Score LS Mean and Change from Baseline between Tadalafil OaD and Tadalafil PRN Population
	Method	t-test
	Comments	Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.01
	Confidence Interval	(2-Sided) 95%; -0.06 to 0.08
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.04
	Estimation Comments	LS Mean difference = Tadalafil OaD-Tadalafil PRN

3. Secondary Outcome

Title	Change From Baseline to Endpoint in the Spontaneity Domain of PAIRS
Description	The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Spontaneity score is the average of responses on 9 PAIRS item scores. Spontaneity scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater spontaneity.
Time Frame	baseline, 8 weeks of each treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tadalafil Once a Day [T(OaD)]	Sildenafil as Needed [S(PRN)]	Tadalafil as Needed [T(PRN)]
Arm/Group Description	Tadalafil 5 mg once a day [T(OaD)]	Sildenafil citrate 100 mg as needed [S(PRN)]	Tadalafil 20 mg as needed [T(PRN)]
Measure Participants	351	347	354
Baseline	3.06 (0.48)	3.07 (0.48)	3.07 (0.48)
Change from Baseline	0.10 (0.50)	-0.05 (0.49)	0.07 (0.49)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tadalafil Once a Day [T(OaD)], Sildenafil as Needed [S(PRN)]
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value is for difference between Tadalafil OaD and Sildenafil PRN change from baseline in LS Mean.
	Method	t-test
	Comments	Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.15
	Confidence Interval	(2-Sided) 95%; 0.10 to 0.20
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.03
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Tadalafil Once a Day [T(OaD)], Tadalafil as Needed [T(PRN)]
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.395
	Comments	p-value is for difference between Tadalafil OaD and Tadalafil PRN in change from baseline in LS Mean.
	Method	t-test
	Comments	Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.02
	Confidence Interval	(2-Sided) 95%; -0.03 to 0.07
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.03
	Estimation Comments

4. Secondary Outcome

Title	Change From Baseline to Endpoint in the Time Concerns Domain of PAIRS
Description	The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Time Concerns score is the average of responses on 8 PAIRS item scores. Time Concerns scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence.
Time Frame	baseline, 8 weeks of each treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tadalafil Once a Day [T(OaD)]	Sildenafil as Needed [S(PRN)]	Tadalafil as Needed [T(PRN)]
Arm/Group Description	Tadalafil 5 mg once a day [T(OaD)]	Sildenafil citrate 100 mg as needed [S(PRN)]	Tadalafil 20 mg as needed [T(PRN)]
Measure Participants	351	347	354
Baseline	2.43 (0.53)	2.42 (0.54)	2.42 (0.53)
Change from Baseline	-0.30 (0.03)	0.00 (0.53)	-0.17 (0.55)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tadalafil Once a Day [T(OaD)], Sildenafil as Needed [S(PRN)]
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value is for the difference between Tadalafil OaD and Sildenafil PRN in Change from Baseline in LS Mean.
	Method	t-test
	Comments	Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.31
	Confidence Interval	(2-Sided) 95%; -0.36 to -0.25
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.03
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Tadalafil Once a Day [T(OaD)], Tadalafil as Needed [T(PRN)]
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value is for the difference between Tadalafil OaD and Tadalafil PRN in Change from Baseline in LS Mean.
	Method	t-test
	Comments	Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.14
	Confidence Interval	(2-Sided) 95%; -0.20 to -0.08
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.03
	Estimation Comments

5. Secondary Outcome

Title	Change From Baseline to Endpoint in the Erectile Function Domain of the International Index of Erectile Function (IIEF)
Description	Self-reported erectile function over the past 4 weeks. Scores range from 0 (low or no erectile function) to 5 (high erectile function) on 6 questions (1-5, 15 of the IIEF). Total Erectile Function Domain scores range from 0 to 30.
Time Frame	baseline, 8 weeks of each treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tadalafil Once a Day [T(OaD)]	Sildenafil as Needed [S(PRN)]	Tadalafil as Needed [T(PRN)]
Arm/Group Description	Tadalafil 5 mg once a day [T(OaD)]	Sildenafil citrate 100 mg as needed [S(PRN)]	Tadalafil 20 mg as needed [T(PRN)]
Measure Participants	350	348	355
Baseline	15.60 (6.26)	15.40 (6.27)	15.55 (6.23)
Change from Baseline	8.68 (6.94)	9.70 (7.01)	9.54 (7.00)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tadalafil Once a Day [T(OaD)], Sildenafil as Needed [S(PRN)]
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.004
	Comments	p-value is for the difference between Tadalafil OaD and Sildenafil PRN Change from Baseline in LS Means.
	Method	t-test
	Comments	Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.85
	Confidence Interval	(2-Sided) 95%; -1.43 to -0.27
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.30
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Tadalafil Once a Day [T(OaD)], Tadalafil as Needed [T(PRN)]
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.007
	Comments	p-value is for the difference between Tadalafil OaD and Tadalafil PRN Change from Baseline in LS Means.
	Method	t-test
	Comments	Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.80
	Confidence Interval	(2-Sided) 95%; -1.37 to -0.22
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.29
	Estimation Comments

6. Secondary Outcome

Title	Change From Baseline to Endpoint in the Proportion of Days With at Least One Morning Erection
Time Frame	baseline, 8 weeks of each treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tadalafil Once a Day [T(OaD)]	Tadalafil as Needed [T(PRN)]	Sildenafil as Needed [S(PRN)]
Arm/Group Description	Tadalafil 5 mg once a day [T(OaD)]	tadalafil 20 mg as needed [T(PRN)]	Sildenafil citrate 100 mg as needed [S(PRN)]
Measure Participants	352	355	347
Baseline	0.28 (0.26)	0.28 (0.26)	0.27 (0.26)
Change from Baseline	0.26 (0.29)	0.20 (0.25)	0.11 (0.24)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tadalafil Once a Day [T(OaD)], Sildenafil as Needed [S(PRN)]
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value is for difference between Tadalafil OaD and Tadalafil PRN Change from Baseline in LS Means.
	Method	t-test
	Comments	Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.06
	Confidence Interval	(2-Sided) 95%; 0.03 to 0.09
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.01
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Tadalafil Once a Day [T(OaD)], Tadalafil as Needed [T(PRN)]
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value is for difference between Tadalafil OaD and Sildenafil PRN Change from Baseline in LS Means.
	Method	t-test
	Comments	Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.09
	Confidence Interval	(2-Sided) 95%; 0.06 to 0.12
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.01
	Estimation Comments

7. Secondary Outcome

Title	Change From Baseline to Endpoint in the Intercourse Satisfaction (IS) Domain of the IIEF
Description	Self-reported intercourse satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 3 questions of the IIEF-IS domain range from 0 to 15.
Time Frame	baseline, 8 weeks of each treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tadalafil Once a Day [T(OaD)]	Sildenafil as Needed [S(PRN)]	Tadalafil as Needed [T(PRN)]
Arm/Group Description	Tadalafil 5 mg once a day [T(OaD)]	Sildenafil citrate 100 mg as needed [S(PRN)]	Tadalafil 20 mg as needed [T(PRN)]
Measure Participants	350	348	355
Baseline	8.35 (2.76)	8.34 (2.77)	8.37 (2.73)
Change from Baseline	3.33 (3.16)	3.99 (3.17)	3.83 (3.13)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tadalafil Once a Day [T(OaD)], Sildenafil as Needed [S(PRN)]
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value is for difference between Tadalafil OaD and Sildenafil PRN Change from Baseline in LS Means.
	Method	t-test
	Comments	Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.64
	Confidence Interval	(2-Sided) 95%; -0.91 to -0.36
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.14
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Tadalafil Once a Day [T(OaD)], Tadalafil as Needed [T(PRN)]
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value is for difference between Tadalafil OaD and Tadalafil PRN Change from Baseline in LS Means.
	Method	t-test
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.51
	Confidence Interval	(2-Sided) 95%; -0.78 to -0.23
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.14
	Estimation Comments

8. Secondary Outcome

Title	Change From Baseline to Endpoint in the Overall Satisfaction (OS) Domain of the IIEF
Description	Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-OS domain range from 0 to 10.
Time Frame	baseline, 8 weeks of each treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tadalafil Once a Day [T(OaD)]	Sildenafil as Needed [S(PRN)]	Tadalafil as Needed [T(PRN)]
Arm/Group Description	Tadalafil 5 mg once a day [T(OaD)]	Sildenafil citrate 100 mg as needed [S(PRN)]	Tadalafil 20 mg as needed [T(PRN)]
Measure Participants	350	348	355
Baseline	5.26 (2.34)	5.22 (2.36)	5.27 (2.34)
Change from Baseline	2.60 (2.61)	2.87 (2.55)	2.84 (2.58)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tadalafil Once a Day [T(OaD)], Sildenafil as Needed [S(PRN)]
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.055
	Comments	p-value is for the difference between Tadalafil OaD and Sildenafil PRN Change from Baseline in LS Means.
	Method	t-test
	Comments	Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.22
	Confidence Interval	(2-Sided) 95%; -0.44 to 0.00
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.11
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Tadalafil Once a Day [T(OaD)], Tadalafil as Needed [T(PRN)]
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.046
	Comments	p-value is for the difference between Tadalafil OaD and Tadalafil PRN Change from Baseline in LS Means.
	Method	t-test
	Comments	Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.22
	Confidence Interval	(2-Sided) 95%; -0.44 to 0.00
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.11
	Estimation Comments

9. Secondary Outcome

Title	Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Score at Endpoint
Description	EDITS is a questionnaire-based inventory capturing a participant's subjective evaluation of treatment for the participant's erection problems. All items on the 11-item Patient EDITS were scored from zero (no satisfaction or dissatisfaction) to four (high satisfaction). The EDITS Summary Score (transformed) is obtained by adding each individual score for all questions, dividing by the number of questions, and multiplying by 25, so that EDITS scores could range from a low of 0 (extremely low treatment satisfaction) to a high of 100 (extremely high treatment satisfaction).
Time Frame	8 weeks of each treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tadalafil Once a Day [T(OaD)]	Sildenafil as Needed [S(PRN)]	Tadalafil as Needed [T(PRN)]
Arm/Group Description	Tadalafil 5 mg once a day [T(OaD)]	Sildenafil citrate 100 mg as needed [S(PRN)]	Tadalafil 20 mg as needed [T(PRN)]
Measure Participants	351	348	355
Mean (Standard Deviation) [units on a scale]	75.81 (22.36)	75.68 (19.58)	79.50 (19.56)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tadalafil Once a Day [T(OaD)], Sildenafil as Needed [S(PRN)]
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.004
	Comments	p-value is for the difference between Tadalafil PRN and Sildenafil PRN change in LS Means.
	Method	t-test
	Comments	Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.66
	Confidence Interval	(2-Sided) 95%; 1.16 to 6.17
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.27
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Tadalafil Once a Day [T(OaD)], Tadalafil as Needed [T(PRN)]
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.006
	Comments	p-value is for the difference between Tadalafil OaD and Tadalafil PRN change in LS Means.
	Method	t-test
	Comments	Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-3.55
	Confidence Interval	(2-Sided) 95%; -6.05 to -1.04
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.27
	Estimation Comments

10. Secondary Outcome

Title	Number of Participants With at Least One Serious Adverse Event
Description	Serious adverse events are listed in the Reported Adverse Event module.
Time Frame	baseline through 26 weeks (including two washout periods of 1 week each)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tadalafil Once a Day [T(OaD)]	Sildenafil as Needed [S(PRN)]	Tadalafil as Needed [T(PRN)]
Arm/Group Description	Tadalafil 5 mg once a day [T(OaD)]	Sildenafil citrate 100 mg as needed [S(PRN)]	Tadalafil 20 mg as needed [T(PRN)]
Measure Participants	378	378	378
Number [participants]	4 6.5%	5 7.9%	2 3.2%

11. Secondary Outcome

Title	Change From Baseline to Endpoint in the Self-Esteem And Relationship (SEAR) Questionnaire Transformed Total Score
Description	Measures improvement in self-esteem and relationship satisfaction. Questionnaire consists of two domains, Sexual Relationship (items 1-8) and Confidence (items 9-14). Overall score is transformed onto a 0 (least favorable) to 100 (most favorable) scale. Overall score was calculated from two domains and subscales scores.
Time Frame	baseline, 8 weeks of each treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tadalafil Once a Day [T(OaD)]	Sildenafil as Needed [S(PRN)]	Tadalafil as Needed [T(PRN)]
Arm/Group Description	Tadalafil 5 mg once a day [T(OaD)]	Sildenafil citrate 100 mg as needed [S(PRN)]	Tadalafil 20 mg as needed [T(PRN)]
Measure Participants	348	347	355
Baseline	50.28 (21.36)	50.50 (21.58)	50.69 (21.32)
Change from Baseline	22.94 (24.86)	22.87 (24.43)	24.13 (24.53)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tadalafil Once a Day [T(OaD)], Sildenafil as Needed [S(PRN)]
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.915
	Comments	p-value is for the difference between Tadalafil OaD and Sildenafil PRN Change from Baseline in LS Means.
	Method	t-test
	Comments	Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.11
	Confidence Interval	(2-Sided) 95%; -1.95 to 2.17
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.05
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Tadalafil Once a Day [T(OaD)], Tadalafil as Needed [T(PRN)]
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.212
	Comments	p-value is for the difference between Tadalafil OaD and Tadalafil PRN Change from Baseline in LS Means.
	Method	t-test
	Comments	Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.30
	Confidence Interval	(2-Sided) 95%; -3.35 to 0.74
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.04
	Estimation Comments

12. Secondary Outcome

Title	Question 1 "I Felt as if I Did Not Have ED" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint
Description	Scores for Question 1 range from 0 (not at all) to 4 (extremely).
Time Frame	8 weeks of each treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tadalafil Once a Day [T(OaD)]	Sildenafil as Needed [S(PRN)]	Tadalafil as Needed [T(PRN)]
Arm/Group Description	Tadalafil 5 mg once a day [T(OaD)]	Sildenafil citrate 100 mg as needed [S(PRN)]	Tadalafil 20 mg as needed [T(PRN)]
Measure Participants	349	348	355
Mean (Standard Deviation) [units on a scale]	1.83 (1.25)	1.78 (1.13)	1.77 (1.22)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tadalafil Once a Day [T(OaD)], Sildenafil as Needed [S(PRN)]
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.403
	Comments	p-value is for the difference between Tadalafil OaD and Sildenafil PRN in LS Means.
	Method	Generalized Linear Mixed Model
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.07
	Confidence Interval	(2-Sided) 95%; -0.09 to 0.22
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Tadalafil Once a Day [T(OaD)], Tadalafil as Needed [T(PRN)]
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.367
	Comments	p-value is for the difference between Tadalafil OaD and Tadalafil PRN in LS Means.
	Method	Generalized Linear Mixed Model
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.07
	Confidence Interval	(2-Sided) 95%; -0.08 to 0.23
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments

13. Secondary Outcome

Title	Question 2 "I Felt in Control of my Sex Life" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint
Description	Scores for Question 2 range from 0 (not at all) to 4 (extremely).
Time Frame	8 weeks of each treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tadalafil Once a Day [T(OaD)]	Sildenafil as Needed [S(PRN)]	Tadalafil as Needed [T(PRN)]
Arm/Group Description	Tadalafil 5 mg once a day [T(OaD)]	Sildenafil citrate 100 mg as needed [S(PRN)]	Tadalafil 20 mg as needed [T(PRN)]
Measure Participants	349	348	355
Mean (Standard Deviation) [units on a scale]	2.33 (1.09)	2.14 (1.01)	2.36 (1.10)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tadalafil Once a Day [T(OaD)], Sildenafil as Needed [S(PRN)]
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments	p-value is for the difference between Tadalafil OaD and Sildenafil PRN in LS Means.
	Method	Generalized Linear Mixed Model
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.20
	Confidence Interval	(2-Sided) 95%; 0.07 to 0.32
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.06
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Tadalafil Once a Day [T(OaD)], Tadalafil as Needed [T(PRN)]
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.722
	Comments	p-value is for the difference between Tadalafil OaD and Tadalafil PRN in LS Means.
	Method	Generalized Linear Mixed Model
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.02
	Confidence Interval	(2-Sided) 95%; -0.15 to 0.10
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.06
	Estimation Comments

14. Secondary Outcome

Title	Question 3 "I Felt the Drug Was in Control of my Erections" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint
Description	Scores for Question 3 range from 0 (not at all) to 4 (extremely).
Time Frame	8 weeks of each treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tadalafil Once a Day [T(OaD)]	Sildenafil as Needed [S(PRN)]	Tadalafil as Needed [T(PRN)]
Arm/Group Description	Tadalafil 5 mg once a day [T(OaD)]	Sildenafil citrate 100 mg as needed [S(PRN)]	Tadalafil 20 mg as needed [T(PRN)]
Measure Participants	349	348	355
Mean (Standard Deviation) [units on a scale]	1.99 (1.19)	2.28 (1.12)	2.50 (1.14)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tadalafil Once a Day [T(OaD)], Sildenafil as Needed [S(PRN)]
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value is for the difference between Tadalafil OaD and Sildenafil PRN in LS Means.
	Method	Generalized Linear Mixed Model
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.51
	Confidence Interval	(2-Sided) 95%; -0.65 to -0.37
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.07
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Tadalafil Once a Day [T(OaD)], Tadalafil as Needed [T(PRN)]
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-value is for the difference between Tadalafil OaD and Tadalafil PRN in LS Means.
	Method	Generalized Linear Mixed Model
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.29
	Confidence Interval	(2-Sided) 95%; -0.43 to -0.16
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.07
	Estimation Comments

15. Secondary Outcome

Title	Question 4 "I Felt Like a Whole Man" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint
Description	Scores for Question 4 range from 0 (not at all) to 4 (extremely).
Time Frame	8 weeks of each treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tadalafil Once a Day [T(OaD)]	Sildenafil as Needed [S(PRN)]	Tadalafil as Needed [T(PRN)]
Arm/Group Description	Tadalafil 5 mg once a day [T(OaD)]	Sildenafil citrate 100 mg as needed [S(PRN)]	Tadalafil 20 mg as needed [T(PRN)]
Measure Participants	349	348	355
Mean (Standard Deviation) [units on a scale]	2.53 (1.10)	2.57 (1.06)	2.44 (0.99)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tadalafil Once a Day [T(OaD)], Sildenafil as Needed [S(PRN)]
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.070
	Comments	p-value is for the difference between Tadalafil OaD and Sildenafil PRN in LS Means.
	Method	Generalized Linear Mixed Model
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.11
	Confidence Interval	(2-Sided) 95%; -0.01 to 0.22
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.06
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Tadalafil Once a Day [T(OaD)], Tadalafil as Needed [T(PRN)]
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.637
	Comments	p-value is for the difference between Tadalafil OaD and Tadalafil PRN in LS Means.
	Method	Generalized Linear Mixed Model
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.03
	Confidence Interval	(2-Sided) 95%; -0.14 to 0.09
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.06
	Estimation Comments

Adverse Events

Arm/Group Title	Tadalafil Once a Day [T(OaD)]		Sildenafil Citrate as Needed [S(PRN)]		Tadalafil as Needed [T(PRN)]
Arm/Group Description	Tadalafil 5 mg once a day [T(OaD)]		Sildenafil citrate 100 mg as needed [S(PRN)]		Tadalafil 20 mg as needed [T(PRN)]
All Cause Mortality
	Tadalafil Once a Day [T(OaD)]		Sildenafil Citrate as Needed [S(PRN)]		Tadalafil as Needed [T(PRN)]
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Tadalafil Once a Day [T(OaD)]		Sildenafil Citrate as Needed [S(PRN)]		Tadalafil as Needed [T(PRN)]
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/378 (1.1%)		5/378 (1.3%)		2/378 (0.5%)
Cardiac disorders
Coronary artery occlusion	0/378 (0%)	0	1/378 (0.3%)	1	0/378 (0%)	0
Myocardial infarction	0/378 (0%)	0	0/378 (0%)	0	1/378 (0.3%)	1
Eye disorders
Retinal detachment	1/378 (0.3%)	1	0/378 (0%)	0	0/378 (0%)	0
Infections and infestations
Pneumonia	2/378 (0.5%)	2	1/378 (0.3%)	1	0/378 (0%)	0
Injury, poisoning and procedural complications
Fall	1/378 (0.3%)	1	0/378 (0%)	0	0/378 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer	0/378 (0%)	0	1/378 (0.3%)	1	0/378 (0%)	0
Oesophageal carcinoma	0/378 (0%)	0	1/378 (0.3%)	1	0/378 (0%)	0
Thyroid cancer	0/378 (0%)	0	0/378 (0%)	0	1/378 (0.3%)	1
Surgical and medical procedures
Elbow operation	0/378 (0%)	0	1/378 (0.3%)	1	0/378 (0%)	0
Other (Not Including Serious) Adverse Events
	Tadalafil Once a Day [T(OaD)]		Sildenafil Citrate as Needed [S(PRN)]		Tadalafil as Needed [T(PRN)]
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	66/378 (17.5%)		73/378 (19.3%)		70/378 (18.5%)
Blood and lymphatic system disorders
Anaemia	0/378 (0%)	0	1/378 (0.3%)	1	1/378 (0.3%)	1
Cardiac disorders
Myocardial ischaemia	0/378 (0%)	0	1/378 (0.3%)	1	0/378 (0%)	0
Tachycardia	1/378 (0.3%)	1	1/378 (0.3%)	1	0/378 (0%)	0
Ear and labyrinth disorders
Vertigo	1/378 (0.3%)	1	0/378 (0%)	0	0/378 (0%)	0
Endocrine disorders
Hypogonadism	0/378 (0%)	0	0/378 (0%)	0	1/378 (0.3%)	1
Hypothyroidism	2/378 (0.5%)	2	2/378 (0.5%)	2	2/378 (0.5%)	2
Eye disorders
Abnormal sensation in eye	1/378 (0.3%)	1	0/378 (0%)	0	0/378 (0%)	0
Conjunctivitis	0/378 (0%)	0	2/378 (0.5%)	2	1/378 (0.3%)	1
Cyanopsia	0/378 (0%)	0	2/378 (0.5%)	2	0/378 (0%)	0
Eye disorder	0/378 (0%)	0	1/378 (0.3%)	1	0/378 (0%)	0
Metamorphopsia	0/378 (0%)	0	1/378 (0.3%)	2	0/378 (0%)	0
Photopsia	1/378 (0.3%)	1	1/378 (0.3%)	1	0/378 (0%)	0
Visual brightness	0/378 (0%)	0	1/378 (0.3%)	10	0/378 (0%)	0
Visual impairment	0/378 (0%)	0	1/378 (0.3%)	1	0/378 (0%)	0
Gastrointestinal disorders
Abdominal discomfort	1/378 (0.3%)	1	2/378 (0.5%)	2	1/378 (0.3%)	1
Abdominal distension	2/378 (0.5%)	2	1/378 (0.3%)	1	1/378 (0.3%)	1
Abdominal pain	0/378 (0%)	0	1/378 (0.3%)	1	0/378 (0%)	0
Abdominal pain upper	2/378 (0.5%)	2	0/378 (0%)	0	0/378 (0%)	0
Anal pruritus	1/378 (0.3%)	1	0/378 (0%)	0	1/378 (0.3%)	1
Diarrhoea	3/378 (0.8%)	3	4/378 (1.1%)	6	2/378 (0.5%)	2
Dyspepsia	6/378 (1.6%)	6	5/378 (1.3%)	15	4/378 (1.1%)	7
Food poisoning	0/378 (0%)	0	0/378 (0%)	0	1/378 (0.3%)	1
Gastritis	2/378 (0.5%)	2	1/378 (0.3%)	1	2/378 (0.5%)	2
Gastrooesophageal reflux disease	3/378 (0.8%)	3	3/378 (0.8%)	9	2/378 (0.5%)	2
Nausea	0/378 (0%)	0	0/378 (0%)	0	2/378 (0.5%)	2
Rectal haemorrhage	1/378 (0.3%)	1	0/378 (0%)	0	0/378 (0%)	0
Vomiting	0/378 (0%)	0	1/378 (0.3%)	2	1/378 (0.3%)	1
General disorders
Asthenia	0/378 (0%)	0	0/378 (0%)	0	1/378 (0.3%)	1
Fatigue	0/378 (0%)	0	1/378 (0.3%)	10	0/378 (0%)	0
Feeling hot	0/378 (0%)	0	0/378 (0%)	0	1/378 (0.3%)	1
Oedema peripheral	1/378 (0.3%)	1	0/378 (0%)	0	2/378 (0.5%)	2
Pain	0/378 (0%)	0	0/378 (0%)	0	1/378 (0.3%)	1
Pyrexia	0/378 (0%)	0	0/378 (0%)	0	1/378 (0.3%)	1
Hepatobiliary disorders
Cholecystitis	1/378 (0.3%)	1	0/378 (0%)	0	0/378 (0%)	0
Immune system disorders
Food allergy	1/378 (0.3%)	1	1/378 (0.3%)	1	1/378 (0.3%)	1
Seasonal allergy	0/378 (0%)	0	0/378 (0%)	0	1/378 (0.3%)	1
Infections and infestations
Ear infection fungal	1/378 (0.3%)	1	0/378 (0%)	0	1/378 (0.3%)	1
Eye infection	1/378 (0.3%)	1	1/378 (0.3%)	1	0/378 (0%)	0
Fungal infection	0/378 (0%)	0	1/378 (0.3%)	1	0/378 (0%)	0
Influenza	1/378 (0.3%)	1	2/378 (0.5%)	2	2/378 (0.5%)	2
Lower respiratory tract infection	2/378 (0.5%)	2	3/378 (0.8%)	3	2/378 (0.5%)	2
Nasopharyngitis	0/378 (0%)	0	3/378 (0.8%)	3	1/378 (0.3%)	1
Onychomycosis	1/378 (0.3%)	1	0/378 (0%)	0	0/378 (0%)	0
Otitis externa	0/378 (0%)	0	0/378 (0%)	0	1/378 (0.3%)	1
Pharyngotonsillitis	1/378 (0.3%)	1	0/378 (0%)	0	0/378 (0%)	0
Pneumonia bacterial	1/378 (0.3%)	1	0/378 (0%)	0	0/378 (0%)	0
Postoperative wound infection	1/378 (0.3%)	1	0/378 (0%)	0	0/378 (0%)	0
Rhinitis	2/378 (0.5%)	2	2/378 (0.5%)	2	1/378 (0.3%)	1
Sinusitis	0/378 (0%)	0	1/378 (0.3%)	1	1/378 (0.3%)	1
Upper respiratory tract infection	0/378 (0%)	0	1/378 (0.3%)	1	0/378 (0%)	0
Urinary tract infection	1/378 (0.3%)	1	0/378 (0%)	0	1/378 (0.3%)	1
Viral infection	1/378 (0.3%)	1	0/378 (0%)	0	0/378 (0%)	0
Injury, poisoning and procedural complications
Foot fracture	1/378 (0.3%)	1	0/378 (0%)	0	0/378 (0%)	0
Joint sprain	1/378 (0.3%)	1	0/378 (0%)	0	1/378 (0.3%)	1
Ligament sprain	0/378 (0%)	0	0/378 (0%)	0	1/378 (0.3%)	1
Lower limb fracture	0/378 (0%)	0	0/378 (0%)	0	1/378 (0.3%)	1
Muscle strain	3/378 (0.8%)	3	1/378 (0.3%)	1	2/378 (0.5%)	2
Skin laceration	1/378 (0.3%)	1	0/378 (0%)	0	1/378 (0.3%)	1
Soft tissue injury	1/378 (0.3%)	1	1/378 (0.3%)	1	0/378 (0%)	0
Upper limb fracture	1/378 (0.3%)	1	1/378 (0.3%)	1	0/378 (0%)	0
Wound	0/378 (0%)	0	1/378 (0.3%)	1	0/378 (0%)	0
Investigations
Blood pressure increased	1/378 (0.3%)	1	1/378 (0.3%)	1	1/378 (0.3%)	1
Metabolism and nutrition disorders
Diabetes mellitus	1/378 (0.3%)	1	1/378 (0.3%)	1	1/378 (0.3%)	1
Gout	0/378 (0%)	0	0/378 (0%)	0	1/378 (0.3%)	1
Hypercholesterolaemia	0/378 (0%)	0	2/378 (0.5%)	2	2/378 (0.5%)	2
Type 2 diabetes mellitus	0/378 (0%)	0	0/378 (0%)	0	1/378 (0.3%)	1
Musculoskeletal and connective tissue disorders
Arthralgia	1/378 (0.3%)	1	1/378 (0.3%)	1	0/378 (0%)	0
Back pain	3/378 (0.8%)	4	3/378 (0.8%)	3	5/378 (1.3%)	5
Flank pain	0/378 (0%)	0	0/378 (0%)	0	1/378 (0.3%)	1
Musculoskeletal pain	0/378 (0%)	0	1/378 (0.3%)	1	0/378 (0%)	0
Musculoskeletal stiffness	0/378 (0%)	0	1/378 (0.3%)	2	0/378 (0%)	0
Myalgia	5/378 (1.3%)	5	0/378 (0%)	0	1/378 (0.3%)	1
Pain in extremity	0/378 (0%)	0	1/378 (0.3%)	1	0/378 (0%)	0
Rotator cuff syndrome	1/378 (0.3%)	1	0/378 (0%)	0	1/378 (0.3%)	1
Spinal osteoarthritis	0/378 (0%)	0	1/378 (0.3%)	1	1/378 (0.3%)	1
Nervous system disorders
Amnesia	0/378 (0%)	0	1/378 (0.3%)	1	1/378 (0.3%)	1
Dizziness	0/378 (0%)	0	2/378 (0.5%)	19	0/378 (0%)	0
Headache	10/378 (2.6%)	10	13/378 (3.4%)	20	8/378 (2.1%)	18
Migraine	1/378 (0.3%)	1	1/378 (0.3%)	1	1/378 (0.3%)	1
Nerve compression	1/378 (0.3%)	1	1/378 (0.3%)	1	1/378 (0.3%)	1
Psychiatric disorders
Agitation	0/378 (0%)	0	0/378 (0%)	0	1/378 (0.3%)	1
Insomnia	1/378 (0.3%)	1	1/378 (0.3%)	1	0/378 (0%)	0
Reproductive system and breast disorders
Balanitis	0/378 (0%)	0	0/378 (0%)	0	1/378 (0.3%)	1
Ejaculation failure	0/378 (0%)	0	1/378 (0.3%)	4	2/378 (0.5%)	2
Perineal pain	0/378 (0%)	0	1/378 (0.3%)	1	0/378 (0%)	0
Priapism	0/378 (0%)	0	1/378 (0.3%)	1	0/378 (0%)	0
Prostatitis	1/378 (0.3%)	1	1/378 (0.3%)	1	1/378 (0.3%)	1
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	1/378 (0.3%)	1	1/378 (0.3%)	1	1/378 (0.3%)	1
Cough	1/378 (0.3%)	1	1/378 (0.3%)	1	1/378 (0.3%)	1
Dyspnoea exertional	0/378 (0%)	0	0/378 (0%)	0	1/378 (0.3%)	1
Emphysema	0/378 (0%)	0	1/378 (0.3%)	1	0/378 (0%)	0
Nasal congestion	5/378 (1.3%)	5	8/378 (2.1%)	15	3/378 (0.8%)	3
Oropharyngeal pain	1/378 (0.3%)	1	1/378 (0.3%)	1	0/378 (0%)	0
Productive cough	0/378 (0%)	0	0/378 (0%)	0	1/378 (0.3%)	1
Skin and subcutaneous tissue disorders
Rash	1/378 (0.3%)	1	0/378 (0%)	0	1/378 (0.3%)	1
Surgical and medical procedures
Cataract operation	1/378 (0.3%)	2	1/378 (0.3%)	1	0/378 (0%)	0
Vascular disorders
Flushing	6/378 (1.6%)	6	8/378 (2.1%)	26	3/378 (0.8%)	3
Hot flush	0/378 (0%)	0	0/378 (0%)	0	2/378 (0.5%)	2
Hypertension	2/378 (0.5%)	2	2/378 (0.5%)	2	4/378 (1.1%)	4

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.