Tadalafil Taken Daily Compared to Placebo on Improvement of Getting and Maintaining an Erection and Sexual Quality of Life
Status and phase
Completed
Phase 3
Conditions
Impotence
Treatments
Drug: Placebo
Drug: tadalafil
Details and patient eligibility
About
To determine if tadalafil 5 mg daily compared to placebo when given for 12 weeks improves getting and maintaining an erection in men with erectile dysfunction and if there are improvements in the sexual quality of life of the man and his female study partner
Enrollment
342 patients
Sex
Male
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion criteria
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
Exclusion criteria
- 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.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
342 participants in 2 patient groups, including a placebo group
1
Placebo Comparator group
Description:
Placebo
Treatment:
Drug: Placebo
2
Active Comparator group
Description:
5 mg tadalafil
Treatment:
Drug: tadalafil
Trial contacts and locations
19
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal
© Copyright 2026 Veeva Systems