A Study of Semen Characteristics After 9 Months of Daily Tadalafil 20 mg
- Registration Number
- NCT00382135
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 282
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 placebo placebo tablet 2 tadalafil 20 mg tadalafil tablet
- Primary Outcome Measures
Name Time Method Change in sperm production measured at baseline and after 9 months of treatment. 40 weeks
- Secondary Outcome Measures
Name Time Method Changes in other semen characteristics and reproductive hormones. 40 weeks
Trial Locations
- 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