Phase 3 N=378 Randomized Treatment

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

Erectile Dysfunction

Bottom Line

View on ClinicalTrials.gov: NCT00734604 ↗

Enrolled (actual)

378

Serious AEs

1.0%

Results posted

Nov 2010

Primary outcome: Primary: 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) — 2.24; 2.23; 0.50; 0.39 units on a scale — p=0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: tadalafil once a day [T(OaD)] (Drug); sildenafil citrate as needed [S(PRN)] (Drug); tadalafil as needed [T(PRN)] (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: Eli Lilly and Company
Primary completion: Sep 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY 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)	2.24; 2.23; 0.50; 0.39	0.001 sig
SECONDARY 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)	2.24; 2.24; 0.50; 0.50	0.872
SECONDARY Change From Baseline to Endpoint in the Spontaneity Domain of PAIRS	3.06; 3.07; 3.07; 0.10; -0.05; 0.07	<0.001 sig
SECONDARY Change From Baseline to Endpoint in the Time Concerns Domain of PAIRS	2.43; 2.42; 2.42; -0.30; 0.00; -0.17	<0.001 sig
SECONDARY Change From Baseline to Endpoint in the Erectile Function Domain of the International Index of Erectile Function (IIEF)	15.60; 15.40; 15.55; 8.68; 9.70; 9.54	0.004 sig
SECONDARY Change From Baseline to Endpoint in the Proportion of Days With at Least One Morning Erection	0.28; 0.28; 0.27; 0.26; 0.20; 0.11	<0.001 sig
SECONDARY Change From Baseline to Endpoint in the Intercourse Satisfaction (IS) Domain of the IIEF	8.35; 8.34; 8.37; 3.33; 3.99; 3.83	<0.001 sig
SECONDARY Change From Baseline to Endpoint in the Overall Satisfaction (OS) Domain of the IIEF	5.26; 5.22; 5.27; 2.60; 2.87; 2.84	0.055
SECONDARY Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Score at Endpoint	75.81; 75.68; 79.50	0.004 sig
SECONDARY Number of Participants With at Least One Serious Adverse Event	4; 5; 2	—
SECONDARY Change From Baseline to Endpoint in the Self-Esteem And Relationship (SEAR) Questionnaire Transformed Total Score	50.28; 50.50; 50.69; 22.94; 22.87; 24.13	0.915
SECONDARY Question 1 "I Felt as if I Did Not Have ED" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint	1.83; 1.78; 1.77	0.403
SECONDARY Question 2 "I Felt in Control of my Sex Life" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint	2.33; 2.14; 2.36	0.002 sig
SECONDARY Question 3 "I Felt the Drug Was in Control of my Erections" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint	1.99; 2.28; 2.50	<0.001 sig
SECONDARY Question 4 "I Felt Like a Whole Man" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint	2.53; 2.57; 2.44	0.070

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).

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00734604). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.