A Study of Semen Characteristics After 9 Months of Daily Tadalafil 20 mg

Lilly

Status and phase: Completed; Phase 4

Conditions: Erectile Dysfunction

Treatments: Drug: placebo; Drug: tadalafil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00382135

7011

H6D-MC-LVFE

Details and patient eligibility

About

This is a multicenter, randomized, double-blind, placebo-controlled, fixed dose, parallel design study to evaluate effects on semen characteristics after 40 weeks of daily dosing with 20 mg tadalafil.

Enrollment: 282 patients

Sex: Male

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male subjects or men with mild erectile dysfunction
• At least 45 years of age
• With specified semen characteristics.

Exclusion criteria

• Certain chronic medical conditions including cardiac disease, congestive heart failure, kidney or liver disease, cancer and HIV
• A history of certain endocrine or hormonal abnormalities
• A history of significant testicular/genital abnormalities
• Any significant reproductive abnormality identified at the start of the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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282 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

placebo tablet

Treatment:

Drug: placebo

2

Active Comparator group

Description:

20 mg tadalafil tablet

Treatment:

Drug: tadalafil