Conditions

Outcome Measures

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

Change From Baseline to Week 12 Endpoint in the International Index of Erectile Function - Intercourse Satisfaction Domain - Subject Response
Baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Overall Satisfaction Domain of the International Index of Erectile Function (IIEF-OS) - Subject Response
Baseline and 12 weeks
Sexual Life Quality Questionnaire (SLQQ) Treatment Satisfaction Domain
12 weeks
Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Sexual Encounter Profile (SEP) Questions 4 and 5 - Subject Response
Baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Partner-Sexual Encounter Profile (SEP) Question 3 - Partner Response
Baseline and 12 weeks
+6 more secondary outcomes

PLACEBO COMPARATOR

Placebo

Drug: Placebo

ACTIVE COMPARATOR

5 mg tadalafil

Drug: tadalafil

5 mg tadalafil tablet taken by mouth once a day for 12 weeks

Also known as: LY450190, Cialis, IC351

2

placebo tablet taken by mouth once a day for 12 weeks

1

Age18 Years+

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Male
History of erectile dysfunction (ED) for at least 3 months duration
Anticipate having the same female partner willing to participate throughout the study
At least 18 years of age at Visit 1 and agree to make at least 4 sexual attempts during the early phase of the study
Adequate partner sexual function as determined by a Female Sexual Function Index
Willing to record responses to efficacy questionnaires, sexual quality of life questionnaires and other instruments used in the study

May not participate in the study if you have taken tadalafil previously.
History of cardiac conditions including angina requiring treatment with nitrates, heart disease of coronary conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for specified time before starting the study.
Have sexual partner not willing to complete the scales.
Use of nitrates.

Contact the study team to confirm eligibility.