Clinical trial NCT00333281: A Study of Visual Effects of Erectile Dysfunction Medications Dosed Daily for Six Months
Official title: A Randomized, Double-Blind, Parallel-Design, Placebo-Controlled Study to Evaluate the Effects of 5 mg Tadalafil (IC351, LY450190) and 50 mg Sildenafil Administered Once Daily for 6 Months on Visual Function in Healthy Subjects or Subjects With Mild Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Erectile Dysfunction
Keywords: Healthy Volunteers
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: ICOS Corporation
First posted: 2006-06-02
Enrollment: 198
Sex: MALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the effects on vision of six months of daily dosing of 5 mg tadalafil or 50 mg sildenafil compared with placebo.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects or males with mild erectile dysfunction (ED).
* Between the ages of 30 and 65 years, inclusive.

Exclusion Criteria:

* Phosphodiesterase type 5 (PDE5) inhibitor therapy (tadalafil, sildenafil, or vardenafil) within 6 weeks of the start of the study.
* Diagnosis of diabetes mellitus.
* Any chronic illness or medication that is a risk factor for eye disease or any medication that causes retinal toxicity or affects visual function.
* Certain chronic medical conditions including unstable angina pectoris, severe renal \[kidney\] insufficiency, clinically significant hepatobiliary \[liver, bile duct\] disease, cancer, and AIDS/HIV.
* A history of clinically significant chronic ophthalmologic disease or any significant visual abnormality identified at the start of the study.

Primary outcomes:
measure: Change in dark-adapted bright flash b-wave amplitude on electroretinography (ERG) testing at baseline, 3 & 6 months on drug, and 4-6 weeks after discontinuation of drug.
Secondary outcomes:
measure: Five other ERG waveform components; intraocular pressure; visual acuity; peripheral vision; color discrimination; and inspection of anterior chamber, lens, and retinal anatomy.
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: 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.
state: Indiana
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: Cordell WH, Maturi RK, Costigan TM, Marmor MF, Weleber RG, Coupland SG, Danis RP, McGettigan JW Jr, Antoszyk AN, Klise S, Sides GD; ERG Testing During Chronic PDE5 Inhibitor Administration (ERG-PDE5i) Consortium. Retinal effects of 6 months of daily use of tadalafil or sildenafil. Arch Ophthalmol. 2009 Apr;127(4):367-73. doi: 10.1001/archophthalmol.2009.36.