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

Lilly

Status and phase: Completed; Phase 3

Conditions: Erectile Dysfunction

Treatments: Drug: tadalafil once a day [T(OaD)]; Drug: tadalafil as needed [T(PRN)]; Drug: sildenafil citrate as needed [S(PRN)]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00734604

12313

H6D-CR-S024 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 378 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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378 participants in 6 patient groups

T(OaD)/S(PRN)/T(PRN)

Experimental 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

Treatment:

Drug: sildenafil citrate as needed [S(PRN)]

Drug: tadalafil as needed [T(PRN)]

Drug: tadalafil once a day [T(OaD)]

T(OaD)/T(PRN)/S(PRN)

Experimental group

Description:

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

Treatment:

Drug: sildenafil citrate as needed [S(PRN)]

Drug: tadalafil as needed [T(PRN)]

Drug: tadalafil once a day [T(OaD)]

S(PRN)/T(OaD)/T(PRN)

Experimental group

Description:

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

Treatment:

Drug: sildenafil citrate as needed [S(PRN)]

Drug: tadalafil as needed [T(PRN)]

Drug: tadalafil once a day [T(OaD)]

S(PRN)/T(PRN)/T(OaD)

Experimental group

Description:

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

Treatment:

Drug: sildenafil citrate as needed [S(PRN)]

Drug: tadalafil as needed [T(PRN)]

Drug: tadalafil once a day [T(OaD)]

T(PRN)/T(OaD)/S(PRN)

Experimental group

Description:

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

Treatment:

Drug: sildenafil citrate as needed [S(PRN)]

Drug: tadalafil as needed [T(PRN)]

Drug: tadalafil once a day [T(OaD)]

T(PRN)/S(PRN)/T(OaD)

Experimental group

Description:

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

Treatment:

Drug: sildenafil citrate as needed [S(PRN)]

Drug: tadalafil as needed [T(PRN)]

Drug: tadalafil once a day [T(OaD)]