A Study in Erectile Dysfunction

NCT ID: NCT00833638

Last Updated: 2010-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 372 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2009-06-30

Brief Summary

The purpose of this study is to determine the day of onset of efficacy of tadalafil dosed once-a-day.

Conditions

Erectile Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Tadalafil 2.5 mg

No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.

Group Type: EXPERIMENTAL

Tadalafil

Intervention Type: DRUG

Orally once daily

Tadalafil 5 mg

No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.

Group Type: EXPERIMENTAL

Tadalafil

Intervention Type: DRUG

Orally once daily

Placebo

No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

One tablet orally daily

Tadalafil

Intervention Type: DRUG

Orally once daily

Interventions

Placebo

One tablet orally daily

Intervention Type: DRUG

Tadalafil

Orally once daily

Intervention Type: DRUG

Other Intervention Names

Cialis; LY450190

Eligibility Criteria

Inclusion Criteria

• Male and at least 18 years old, with at least a 3-month history of erectile dysfunction (ED).
• Anticipate having same adult female sexual partner during the study.
• Agree to make at least 4 sexual intercourse attempts with the female partner during the 4-week run-in phase without medication.
• Agree to make at least 1 sexual intercourse attempt per day with the female partner during days 1-4 following randomization (with a minimum of three attempts required during that period). Also agree to make at least 3 intercourse attempts during days 5-14 following randomization.
• Agree not to use any other ED treatment during the study and for 24 hours after the final study visit.

• Female and at least 18 years old.
• Agree to make at least 4 sexual intercourse attempts with the male sexual study partner during the 4-week run-in phase without medication.
• Agree to make at least 1 sexual intercourse attempt per day with the male partner during days 1-4 following randomization
• Agree to make at least 3 intercourse attempts during days 5-14 following randomization.

Exclusion Criteria

• Previous or current treatment with tadalafil or any phosphodiesterase type 5 (PDE5) inhibitor on a daily basis for once daily use.
• ED caused by other primary sexual disorders, or untreated or inadequately treated endocrine disease.
• History of radical prostatectomy, other pelvic surgery or penile implant.
• Clinically significant penile deformity in the opinion of the investigator.
• Clinically significant renal insufficiency, or hepatobiliary disease as determined by the investigator.
• Glycosylated hemoglobin of >11%.
• Present with chronic stable angina treated with long-acting nitrates, or with chronic stable angina requiring short-acting nitrates in the last 90 days, or with angina occurring during sexual intercourse in the last 6 months.
• Have a history of significant central nervous system injuries within the last 6 months.
• Have a history of Human Immunodeficiency Virus infection.
• Have any condition that would interfere with the subject's ability to provide informed consent or comply with study instructions, would place subject at increased risk, or might confound the interpretation of the study results.
• Currently receive treatment with nitrates, cancer chemotherapy, or antiandrogens (except finasteride taken as Propecia or Proscar, or Avodart [dutasteride]).
• History of drug, alcohol, or substance abuse within the past 6 months, as assessed by the investigator.
• Previously completed or withdrawn from any other study investigating tadalafil for once daily use.
• Received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
• Prior ineffective treatment with any PDE5 inhibitor in the opinion of the investigator.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Eli Lilly

Principal Investigators

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

Eli Lilly and Company

Locations

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.

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

H6D-US-LVHZ

Identifier Type: OTHER

Identifier Source: secondary_id

12719

Identifier Type: -

Identifier Source: org_study_id