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

Eli Lilly and Company282 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

282

Conditions

Erectile Dysfunction

Interventions

tadalafilDRUG

20mg tadalafil tablet taken by mouth once a day for 40 weeks

placeboDRUG

Placebo tablet taken by mouth once a day for 40 weeks

Eligibility

Sex: MALEMin age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Bothell, Washington, United States

Outcomes

Primary Outcomes

Change in sperm production measured at baseline and after 9 months of treatment.

Time frame: 40 weeks

Secondary Outcomes

Changes in other semen characteristics and reproductive hormones.

Time frame: 40 weeks

Data from ClinicalTrials.gov

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