A Study in Erectile Dysfunction

NCT00833638 | Completed Phase 4 Results

• 2 other identifiers: 12719H6D-US-LVHZ
• Study Type: interventional
• Target: 372
• Locations: 1 country
• Sites: 1

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

Keywords

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• Earliest Onset Day Measured by Cumulative Percentage of Participants With Yes Response to Sexual Encounter Profile Diary Question 3

  Cumulative percentage of participants achieving successful intercourse, as measured by "yes" responses to Sexual Encounter Profile diary question 3 (SEP3). SEP3 asks if the participant's erection lasted long enough to have successful intercourse.

  4 days during double-blind period

Secondary Outcomes (11)

• Sexual Encounter Profile Diary Question Number 1, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses

  Baseline and 14 days double-blind period

• Sexual Encounter Profile Diary Question Number 2, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses

  Baseline and 14 days double-blind period

• Sexual Encounter Profile Diary Question Number 3, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses

  Baseline and 14 days double-blind period

• Sexual Encounter Profile Diary Question Number 4, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses

  Baseline and 14 days double-blind period

• Sexual Encounter Profile Diary Question Number 5, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses

  Baseline and 14 days double-blind period

Study Arms (3)

Tadalafil 2.5 mg

EXPERIMENTAL

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

Drug: Tadalafil

Tadalafil 5 mg

EXPERIMENTAL

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

Drug: Tadalafil

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo; Drug: Tadalafil

Interventions

Placebo DRUG

One tablet orally daily

Placebo

Tadalafil DRUG

Orally once daily

Also known as: Cialis, LY450190

Placebo; Tadalafil 2.5 mg; Tadalafil 5 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (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.

Indianapolis, Indiana, 46285, United States

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 30, 2009
• First Posted: February 2, 2009
• Study Start: February 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: August 24, 2010
• Results First Posted: August 18, 2010

Record last verified: 2010-08

Locations

US (1)