A Study in Patients With Erectile Dysfunction

Lilly

Status and phase: Completed; Phase 4

Conditions: Erectile Dysfunction

Treatments: Drug: Sildenafil Citrate; Drug: Tadalafil

Study type: Interventional

Funder types: Industry

Identifiers

NCT01122264

13085

H6D-EW-LVIJ (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to investigate if treatment in erectile dysfunction with a long-acting drug (Tadalafil) taken once a day or taken as needed results in a longer treatment adherence and better long term outcomes (over 24 weeks), compared with a short-acting drug (Sildenafil Citrate) taken as needed.

Enrollment: 770 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• History of Erectile Dysfunction (ED) of at least 3 months duration.
• Anticipate having the same adult female sexual partner during the study.
• Agree not to use any other treatment for ED and to participate in recording responses to questionnaires and other instruments used in this study.

Exclusion criteria

• Previous or current treatment with tadalafil or any other phosphodiesterase type 5 (PDE5) inhibitor.
• ED caused by other primary sexual disorders, history of radical prostatectomy or other pelvic surgery with subsequent failure to achieve any erection, or history of penile implant or clinically significant penile deformity.
• ED caused by untreated or inadequately treated endocrine disease.
• Current treatment with doxazosin, nitrates, cancer chemotherapy, or anti-androgens.
• Severe renal or hepatic impairment, history of malignant hypertension.
• Presence or history of specific heart conditions.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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770 participants in 3 patient groups

Tadalafil on demand

Experimental group

Description:

10 milligrams (mg) or 20 mg on demand

Treatment:

Drug: Tadalafil

Tadalafil once a day

Experimental group

Description:

5 mg or 2.5 mg once a day

Treatment:

Drug: Tadalafil

Sildenafil Citrate

Active Comparator group

Description:

50 mg, 100 mg, or 25 mg on demand

Treatment:

Drug: Sildenafil Citrate