Tadalafil Taken Daily Compared to Placebo on Improvement... | NCT00422734

ID	Type	Description	Link
H6D-MC-LVGH

Name	Class
ICOS Corporation	INDUSTRY

Label	Type	Description	Intervention Names
1	Placebo Comparator	Placebo	Drug: Placebo
2	Active Comparator	5 mg tadalafil	Drug: tadalafil

Name	Type	Description	Arm Group Labels	Other Names
tadalafil	Drug	5 mg tadalafil tablet taken by mouth once a day for 12 weeks	2

Measure	Description	Time Frame
Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF)- Erectile Function Domain Score (Sum of IIEF Questions 1-5 and 15)	Measures erectile function over the past 4 weeks on Questions 1-5 and 15 (6 questions) of the International Index of Erecile Function (IIEF) questionnaire. Scores range from 0 (low/no erectile function) to 5 (high erectile function), thus the 6 questions of the IIEF-EF domain range from 0 to 30.	Baseline and 12 weeks
Improvement in the Sexual Quality of Life in the Subject and His Study Partner as Measured by the Sexual Quality of Life (SQoL) Domain of the Sexual Life Quality Questionnaire (SLQQ)	The original item scores (-4 to 4 range) were converted to 0 to 8 scale score by adding 4 to each recorded responses. Each transformed score was multiplied by 12.5 for a total range of 0 to 100. Higher scores are indicative of a higher sexual quality of life.	Baseline and 12 weeks
Change From Baseline to Endpoint in the Percent of "Yes" Responses to Sexual Encounter Profile (SEP) Diary Questions 2 (SEP2) and 3 (SEP3).	The baseline and endpoint score for each SEP question 2 (Insert penis into vagina) and 3 (Successful intercourse) are the subject's percentage of "yes" responses to those questions during the run-in period and postbaseline period, respectively.	Baseline and 12 weeks

Measure	Description	Time Frame
Change From Baseline to Week 12 Endpoint in the International Index of Erectile Function - Intercourse Satisfaction Domain - Subject Response	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.	Baseline and 12 weeks

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
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	35801

PubMed Identifier	Type	Citation	Retractions
24119319	Derived	Porst H, Gacci M, Buttner H, Henneges C, Boess F. Tadalafil once daily in men with erectile dysfunction: an integrated analysis of data obtained from 1913 patients from six randomized, double-blind, placebo-controlled, clinical studies. Eur Urol. 2014 Feb;65(2):455-64. doi: 10.1016/j.eururo.2013.09.037. Epub 2013 Oct 2.
23035781

ID	Title	Description
FG000	Placebo	Placebo tablet taken by mouth once a day for 12 weeks
FG001	Tadalafil	5 mg tadalafil tablet taken by mouth once a day for 12 weeks

ID	Title	Description
BG000	Placebo	Placebo tablet taken by mouth once a day for 12 weeks
BG001	Tadalafil	5 mg tadalafil tablet taken by mouth once a day for 12 weeks
BG002	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF)- Erectile Function Domain Score (Sum of IIEF Questions 1-5 and 15)

Measures erectile function over the past 4 weeks on Questions 1-5 and 15 (6 questions) of the International Index of Erecile Function (IIEF) questionnaire. Scores range from 0 (low/no erectile function) to 5 (high erectile function), thus the 6 questions of the IIEF-EF domain range from 0 to 30.

last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline and 12 weeks

ID	Title	Description
OG000	Placebo	Placebo tablet taken by mouth once a day for 12 weeks
OG001	Tadalafil	5 mg tadalafil tablet taken by mouth once a day for 12 weeks

Units	Counts
Participants	OG00072 OG001244

Title

Denominators

Categories

Title	Measurements
	OG0000.49± 0.781 OG0018.03± 0.449

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The null hypotheses (no treatment effect with respect to IIEF EF domain or SEP2 or SEP3) were each tested at a specified level of 0.05. In order to pass a serial gatekeeper, it was necessary to reject all three hypotheses. The two null hypotheses (no treatment effect with respect to subject SLQQ-SQoL domain and no treatment effect with respect to partner SLQQ-SQoL domain) were then each tested at a significance level of 0.025.	ANCOVA	Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.	<0.001	Hypotheses were tested in a sequential fashion using a gatekeeping strategy and adjusted for multiplicity. Statistical significance at 0.05 level was required for this variable						95

Primary

Improvement in the Sexual Quality of Life in the Subject and His Study Partner as Measured by the Sexual Quality of Life (SQoL) Domain of the Sexual Life Quality Questionnaire (SLQQ)

The original item scores (-4 to 4 range) were converted to 0 to 8 scale score by adding 4 to each recorded responses. Each transformed score was multiplied by 12.5 for a total range of 0 to 100. Higher scores are indicative of a higher sexual quality of life.

last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline and 12 weeks

ID	Title	Description
OG000	Placebo	Placebo tablet taken by mouth once a day for 12 weeks
OG001	Tadalafil	5 mg tadalafil tablet taken by mouth once a day for 12 weeks

Units	Counts
Participants	OG000

Secondary

Change From Baseline to Week 12 Endpoint in the International Index of Erectile Function - Intercourse Satisfaction Domain - Subject Response

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.

last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline and 12 weeks

ID	Title	Description
OG000	Placebo	Placebo tablet taken by mouth once a day for 12 weeks
OG001	Tadalafil	5 mg tadalafil tablet taken by mouth once a day for 12 weeks

Units	Counts
Participants	OG000

Secondary

Change From Baseline to 12 Week Endpoint in Overall Satisfaction Domain of the International Index of Erectile Function (IIEF-OS) - Subject Response

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.

last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline and 12 weeks

ID	Title	Description
OG000	Placebo	Placebo tablet taken by mouth once a day for 12 weeks
OG001	Tadalafil	5 mg tadalafil tablet taken by mouth once a day for 12 weeks

Units	Counts
Participants	OG000

Secondary

Sexual Life Quality Questionnaire (SLQQ) Treatment Satisfaction Domain

The 6 SLQQ-treatment satisfaction questions were answered by subject and partner at Visit 4/Final Visit. Original item scores (1 to 6 range) were converted to 0 to 5 scale by subtracting 1 to each recorded responses. Each transformed score was multiplied by 20. Total range of scores: 0 (low satisfaction) to 100 (high satisfaction).

all randomized participants having post-baseline data measurement on this variable

Posted

Least Squares Mean

Standard Error

units on a scale

12 weeks

ID	Title	Description
OG000	Placebo	Placebo tablet taken by mouth once a day for 12 weeks
OG001	Tadalafil	5 mg tadalafil tablet taken by mouth once a day for 12 weeks

Units	Counts
Participants	OG000

Primary

Change From Baseline to Endpoint in the Percent of "Yes" Responses to Sexual Encounter Profile (SEP) Diary Questions 2 (SEP2) and 3 (SEP3).

The baseline and endpoint score for each SEP question 2 (Insert penis into vagina) and 3 (Successful intercourse) are the subject's percentage of "yes" responses to those questions during the run-in period and postbaseline period, respectively.

all randomized participants having both baseline and at least one post-baseline data measurement

Posted

Least Squares Mean

Standard Error

percent

Baseline and 12 weeks

ID	Title	Description
OG000	Placebo	Placebo tablet taken by mouth once a day for 12 weeks
OG001	Tadalafil	5 mg tadalafil tablet taken by mouth once a day for 12 weeks

Units	Counts
Participants	OG000

Secondary

Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Sexual Encounter Profile (SEP) Questions 4 and 5 - Subject Response

The baseline and endpoint score for each SEP question 4 (Satisfied with hardness) and 5 (Satisfied overall) are the subject's percentage of "yes" responses to those questions during the run-in period and postbaseline period, respectively.

all randomized participants having both baseline and at least one post-baseline data measurement

Posted

Least Squares Mean

Standard Error

percent

Baseline and 12 weeks

ID	Title	Description
OG000	Placebo	Placebo tablet taken by mouth once a day for 12 weeks
OG001	Tadalafil	5 mg tadalafil tablet taken by mouth once a day for 12 weeks

Units	Counts
Participants	OG000

Secondary

Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Partner-Sexual Encounter Profile (SEP) Question 3 - Partner Response

The baseline and endpoint score for partner SEP question 3 (Satisfied overall) are the partner's percentage of "yes" responses to the question during the run-in period and postbaseline period, respectively.

all randomized participants having both baseline and at least one post-baseline data measurement

Posted

Least Squares Mean

Standard Error

percent

Baseline and 12 weeks

ID	Title	Description
OG000	Placebo	Placebo tablet taken by mouth once a day for 12 weeks
OG001	Tadalafil	5 mg tadalafil tablet taken by mouth once a day for 12 weeks

Units	Counts
Participants	OG000

Secondary

Change From Baseline to 12 Week Endpoint in the Satisfaction Domain of the Female Sexual Function Index (FSFI) - Partner Response

The FSFI Satisfaction Domain (items 14-16) measures satisfaction with emotional closeness, sexual relationship, and overall sexual life. Each question is scored on a 0/1 to 5 scale and domain score is calculated by multiplying the total points by 0.4, for a total score range of 0.8 to 6, with higher scores indicating greater satisfaction.

last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline and 12 weeks

ID	Title	Description
OG000	Placebo	Placebo tablet taken by mouth once a day for 12 weeks
OG001	Tadalafil	5 mg tadalafil tablet taken by mouth once a day for 12 weeks

Units	Counts
Participants	OG000

Secondary

Percent of Subjects With "Yes" Responses to Global Assessment Questionnaire (GAQ) - Subject Response

Percent of subjects with "Yes" responses to Question 1 (Improvement in Erections) and Question 2 (Improvement in the Ability to Engage in Sexual Activity)

all randomized participants having post-baseline data measurement on this variable

Posted

Number

percentage of subjects answering Yes

12 weeks

ID	Title	Description
OG000	Placebo	Placebo tablet taken by mouth once a day for 12 weeks
OG001	Tadalafil	5 mg tadalafil tablet taken by mouth once a day for 12 weeks

Units	Counts
Participants	OG000

Secondary

Percent of Partners With "Yes" Responses to Global Assessment Questionnaire (GAQ) - Partner Response

Percent of Partners with "Yes" responses to Question 1 (Improvement in Erections) and Question 2 (Improvement in the Ability to Engage in Sexual Activity)

all randomized participants having post-baseline data measurement on this variable

Posted

Number

percentage of partners answering Yes

12 weeks

ID	Title	Description
OG000	Placebo	Placebo tablet taken by mouth once a day for 12 weeks
OG001	Tadalafil	5 mg tadalafil tablet taken by mouth once a day for 12 weeks

Units	Counts
Participants	OG000

Secondary

Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Partner-Sexual Encounter Profile (SEP) Questions 1 and 2 - Partner Response

The baseline and endpoint score for each SEP question 1 (Achieve some erection) and 2 (Insert penis into vagina) are the partner's percentage of "yes" responses to those questions during the run-in period and postbaseline period, respectively.

all randomized participants having both baseline and at least one post-baseline data measurement

Posted

Least Squares Mean

Standard Error

percent

Baseline and 12 weeks

ID	Title	Description
OG000	Placebo	Placebo tablet taken by mouth once a day for 12 weeks
OG001	Tadalafil	5 mg tadalafil tablet taken by mouth once a day for 12 weeks

Units	Counts
Participants	OG000

Secondary

Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire

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.

last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline and 12 weeks

ID	Title	Description
OG000	Placebo	Placebo tablet taken by mouth once a day for 12 weeks
OG001	Tadalafil	5 mg tadalafil tablet taken by mouth once a day for 12 weeks

Units	Counts
Participants	OG000

Secondary

Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire - Confidence Domain Subscales

Measures improvement in confidence (items 9-14). Confidence domain consists of two subscales (Self-Esteem, items 9-12; Overall Relationship, items 13 and 14). Each domain score, subscale score, and overall score are transformed onto a 0 (least favorable) to 100 (most favorable) scale.

last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline and 12 weeks

ID	Title	Description
OG000	Placebo	Placebo tablet taken by mouth once a day for 12 weeks
OG001	Tadalafil	5 mg tadalafil tablet taken by mouth once a day for 12 weeks

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Hypoacusis	Ear and labyrinth disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0011 events1 affected264 at risk
Hypogonadism	Endocrine disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0011 events1 affected264 at risk
Blepharitis	Eye disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0011 events1 affected264 at risk
Conjunctivitis	Eye disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0011 events1 affected264 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0011 events1 affected264 at risk
Constipation	Gastrointestinal disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected78 at risk EG0010 events0 affected264 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected78 at risk EG0015 events5 affected264 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected78 at risk EG0010 events0 affected264 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG00113 events12 affected264 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0011 events1 affected264 at risk
Gastritis	Gastrointestinal disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0012 events2 affected264 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0015 events5 affected264 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0011 events1 affected264 at risk
Nausea	Gastrointestinal disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0013 events3 affected264 at risk
Toothache	Gastrointestinal disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0011 events1 affected264 at risk
Vomiting	Gastrointestinal disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected78 at risk EG0012 events2 affected264 at risk
Chest pain	General disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0011 events1 affected264 at risk
Discomfort	General disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0011 events1 affected264 at risk
Fatigue	General disorders	MedDRA 8.0	Systematic Assessment	EG0002 events2 affected78 at risk EG0010 events0 affected264 at risk
Oedema mucosal	General disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0011 events1 affected264 at risk
Pyrexia	General disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0011 events1 affected264 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected78 at risk EG0010 events0 affected264 at risk
Amoebic dysentery	Infections and infestations	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0011 events1 affected264 at risk
Anogenital warts	Infections and infestations	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0011 events1 affected264 at risk
Bronchitis	Infections and infestations	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected78 at risk EG0010 events0 affected264 at risk
Gastroenteritis	Infections and infestations	MedDRA 8.0	Systematic Assessment	EG0003 events3 affected78 at risk EG0013 events2 affected264 at risk
Herpes simplex	Infections and infestations	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected78 at risk EG0010 events0 affected264 at risk
Herpes zoster	Infections and infestations	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0011 events1 affected264 at risk
Influenza	Infections and infestations	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0012 events2 affected264 at risk
Nasopharyngitis	Infections and infestations	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0012 events2 affected264 at risk
Onychomycosis	Infections and infestations	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0011 events1 affected264 at risk
Oral herpes	Infections and infestations	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0011 events1 affected264 at risk
Pharyngitis	Infections and infestations	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected78 at risk EG0014 events3 affected264 at risk
Rhinitis	Infections and infestations	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0013 events3 affected264 at risk
Sinusitis	Infections and infestations	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected78 at risk EG0010 events0 affected264 at risk
Tonsillitis	Infections and infestations	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected78 at risk EG0013 events3 affected264 at risk
Tooth infection	Infections and infestations	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected78 at risk EG0010 events0 affected264 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0011 events1 affected264 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected78 at risk EG0010 events0 affected264 at risk
Diabetes mellitus non-insulin-dependent	Metabolism and nutrition disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected78 at risk EG0010 events0 affected264 at risk
Gout	Metabolism and nutrition disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0011 events1 affected264 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected78 at risk EG0010 events0 affected264 at risk
Obesity	Metabolism and nutrition disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0011 events1 affected264 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0011 events1 affected264 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 8.0	Systematic Assessment	EG0002 events1 affected78 at risk EG0015 events5 affected264 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected78 at risk EG0013 events3 affected264 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected78 at risk EG0010 events0 affected264 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0014 events4 affected264 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0011 events1 affected264 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0015 events5 affected264 at risk
Dizziness	Nervous system disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected78 at risk EG0011 events1 affected264 at risk
Headache	Nervous system disorders	MedDRA 8.0	Systematic Assessment	EG0004 events3 affected78 at risk EG00126 events22 affected264 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0011 events1 affected264 at risk
Sciatica	Nervous system disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0011 events1 affected264 at risk
Pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0011 events1 affected264 at risk
Anxiety	Psychiatric disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0011 events1 affected264 at risk
Insomnia	Psychiatric disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected78 at risk EG0010 events0 affected264 at risk
Libido decreased	Psychiatric disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0011 events1 affected264 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0011 events1 affected264 at risk
Ejaculation delayed	Reproductive system and breast disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0011 events1 affected264 at risk
Gynaecomastia	Reproductive system and breast disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0011 events1 affected264 at risk
Hypoaesthesia of genital male	Reproductive system and breast disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0011 events1 affected264 at risk
Painful erection	Reproductive system and breast disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0012 events1 affected264 at risk
Testicular pain	Reproductive system and breast disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected78 at risk EG0010 events0 affected264 at risk
Varicocele	Reproductive system and breast disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0011 events1 affected264 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected78 at risk EG0011 events1 affected264 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0011 events1 affected264 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0011 events1 affected264 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0019 events7 affected264 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected78 at risk EG0011 events1 affected264 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected78 at risk EG0010 events0 affected264 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0011 events1 affected264 at risk
Dental prosthesis placement	Surgical and medical procedures	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0011 events1 affected264 at risk
Hot flush	Vascular disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0012 events2 affected264 at risk
Hypertension	Vascular disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0013 events3 affected264 at risk
Hypotension	Vascular disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected78 at risk EG0010 events0 affected264 at risk

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D012735	Sexual Dysfunction, Physiological
D052801	Male Urogenital Diseases
D020018	Sexual Dysfunctions, Psychological
D001523	Mental Disorders

ID	Term
D002243	Carbolines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D026121	Indole Alkaloids
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006575	Heterocyclic Compounds, 3-Ring

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Placebo tablet taken by mouth once a day for 12 weeks			1		21
EG001	Tadalafil	5 mg tadalafil tablet taken by mouth once a day for 12 weeks			3		77

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pancreatitis	Gastrointestinal disorders	MedDRA 8.0	Systematic Assessment	EG0001 events1 affected78 at risk EG0010 events0 affected264 at risk
Hypersensitivity	Immune system disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0011 events1 affected264 at risk
Gastroenteritis	Infections and infestations	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0011 events1 affected264 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 8.0	Systematic Assessment	EG0000 events0 affected78 at risk EG0011 events1 affected264 at risk