- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00833638
A Study in Erectile Dysfunction
August 18, 2010 updated by: Eli Lilly and Company
Tadalafil 2.5 mg and 5 mg Once a Day Compared to Placebo in Day of Onset of Efficacy
The purpose of this study is to determine the day of onset of efficacy of tadalafil dosed once-a-day.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
372
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Indiana
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Indianapolis, Indiana, United States, 46285
- 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.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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.
Partner Inclusion Criteria:
- 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 any significant cardiac conditions as described in the protocol exclusion criteria.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tadalafil 2.5 mg
No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
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Orally once daily
Other Names:
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Experimental: Tadalafil 5 mg
No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
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Orally once daily
Other Names:
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Placebo Comparator: Placebo
No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
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Orally once daily
Other Names:
One tablet orally daily
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Earliest Onset Day Measured by Cumulative Percentage of Participants With Yes Response to Sexual Encounter Profile Diary Question 3
Time Frame: 4 days during double-blind period
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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.
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4 days during double-blind period
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sexual Encounter Profile Diary Question Number 1, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses
Time Frame: Baseline and 14 days double-blind period
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Assessed was the mean change from baseline in the percentage of "yes" responses to the Sexual Encounter Profile Diary question number 1: "Were you able to achieve at least some erection (some enlargement of the penis)"?
Data are presented as the mean percentage of participants who answered "yes".
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Baseline and 14 days double-blind period
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Sexual Encounter Profile Diary Question Number 2, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses
Time Frame: Baseline and 14 days double-blind period
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Assessed was the mean change from baseline in the percentage of "yes" responses to the Sexual Encounter Profile Diary question number 2: "Were you able insert your penis into your partner's vagina?"
Data are presented as the mean percentage of participants who answered yes.
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Baseline and 14 days double-blind period
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Sexual Encounter Profile Diary Question Number 3, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses
Time Frame: Baseline and 14 days double-blind period
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Assessed was the mean change from baseline in the percentage of "yes" responses to the Sexual Encounter Profile Diary question number 3: "Did your erection last long enough for you to have successful intercourse?"
Data are presented as the mean percentage of participants who answered "yes".
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Baseline and 14 days double-blind period
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Sexual Encounter Profile Diary Question Number 4, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses
Time Frame: Baseline and 14 days double-blind period
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Assessed was the mean change from baseline in the percentage of "yes" responses to the Sexual Encounter Profile Diary question number 4: "Were you satisfied with the hardness of your erection?"
Data are presented as the mean percentage of participants who answered "yes".
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Baseline and 14 days double-blind period
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Sexual Encounter Profile Diary Question Number 5, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses
Time Frame: Baseline and 14 days double-blind period
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Assessed was the mean change from baseline in the percentage of "yes" responses to the Sexual Encounter Profile Diary question number 5: "Were you satisfied overall with this sexual experience?"
Data are presented as the mean percentage of participants who answered "yes".
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Baseline and 14 days double-blind period
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Sexual Encounter Profile Diary Question 3, the Overall Distribution of Time to Onset by Yes Responses
Time Frame: 4 days double-blind period
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Assessed was the median time to onset of efficacy (day when 50% of participants have had at least 1 successful intercourse attempt) within the first 4 days of therapy based on a "yes" response to the sexual encounter profile diary question 3: "Did your erection last long enough for you to have successful intercourse?"
Data are based on participants who responded "yes".
For the placebo group, onset of efficacy was not reached within the first 4 days of therapy, therefore, the analysis timeframe was expanded for this group to determine the median time to onset of efficacy.
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4 days double-blind period
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Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts
Time Frame: 14 days during double-blind period
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Assessed was the cumulative precentage of successful intercourse attempts (successful attempts relative to the total number of intercourse attempts) over the 14-day double-blind treatment period.
A successful attempt was defined by a "yes" response to the sexual encounter profile diary question #3: "Did your erection last long enough for you to have successful intercourse?"
Data are presented as the proportion of intercourse attempts for which participants answered "yes" relative to the total number of intercourse attempts.
Total number of attempts = TNA.
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14 days during double-blind period
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Sexual Encounter Profile Diary Question 3, Percentages of Yes Responses During the Double-blind and Open-label Periods for Participants Who Were Assigned to Placebo in the Double-blind Treatment Period
Time Frame: 14 days double-blind and 14 days open-label
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Assessed were percentages of successful intercourse attempts relative to the total number of intercourse attempts over the 14-day open-label treatment period compared with the 14-day double-blind treatment period by dose group during the double-blind treatment period.
A successful attempt was defined by a "yes" response to the sexual encounter profile diary question #3: "Did your erection last long enough for you to have successful intercourse?"
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14 days double-blind and 14 days open-label
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Sexual Encounter Profile Diary Question 3, Percentages of Yes Responses in the Double-blind Period and the Open-label Period for Participants Who Were Assigned to Tadalafil 2.5 mg in the Double-blind Treatment Period
Time Frame: 14-day double-blind and 14-day open-label
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Assessed were percentages of successful intercourse attempts relative to the total number of intercourse attempts over the 14-day open-label treatment period compared with the 14-day double-blind treatment period by dose group during the double-blind treatment period.
A successful attempt was defined by a "yes" response to the sexual encounter profile diary question #3: "Did your erection last long enough for you to have successful intercourse?"
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14-day double-blind and 14-day open-label
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Sexual Encounter Profile Diary Question 3, Percentages of Yes Responses in the Double-blind Period and the Open-label Period for Participants Who Were Assigned to Tadalafil 5 mg in the Double-blind Treatment Period
Time Frame: 14-day double-blind and 14-day open-label
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Assessed were percentages of successful intercourse attempts relative to the total number of intercourse attempts over the 14-day open-label treatment period compared with the 14-day double-blind treatment period by dose group during the double-blind treatment period.
A successful attempt was defined by a "yes" response to the sexual encounter profile diary question #3: "Did your erection last long enough for you to have successful intercourse?"
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14-day double-blind and 14-day open-label
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Sexual Encounter Profile Diary Question 3, Percentages of Yes Responses During the Double-blind Period and the Open-label Period for Participants Who Didn't Respond to Tadalafil 2.5 mg During Double-blind Period
Time Frame: 14 days double-blind and 14 days open-label
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Assessed were percentages of successful intercourse attempts relative to the total number of intercourse attempts in both treatment periods.
A successful attempt was defined by a "yes" response to the sexual encounter profile diary question #3: "Did your erection last long enough for you to have successful intercourse?"
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14 days double-blind and 14 days open-label
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
January 30, 2009
First Submitted That Met QC Criteria
January 30, 2009
First Posted (Estimate)
February 2, 2009
Study Record Updates
Last Update Posted (Estimate)
August 24, 2010
Last Update Submitted That Met QC Criteria
August 18, 2010
Last Verified
August 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12719
- H6D-US-LVHZ (Other Identifier: Eli Lilly and Company)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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