Erectile DysfunctionPhase 4NCT00833638
A Study in Erectile Dysfunction
A Phase 4 study testing Tadalafil in people with Erectile Dysfunction, run by Eli Lilly and Company at 1 site in United States.
Trial summary
The purpose of this study is to determine the day of onset of efficacy of tadalafil dosed once-a-day. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Tadalafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 372 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jun 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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%.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
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
About this study
Official title: 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.
- Conditions
- Erectile Dysfunction
- Being tested
- Placebo, Tadalafil
- Keywords
- Erectile Dysfunction
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
One tablet orally daily
TadalafilDrug
Also called Cialis, LY450190
Orally once daily
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Tadalafil |
| Placebo | Placebo comparator | No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days. Receives: Drug: Placebo; Drug: Tadalafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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".
Measured: 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
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.
Measured: 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
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".
Measured: 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
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".
Measured: 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
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".
Measured: Baseline and 14 days double-blind period
Sexual Encounter Profile Diary Question 3, the Overall Distribution of Time to Onset by Yes Responses
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.
Measured: 4 days double-blind period
Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts
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.
Measured: 14 days during double-blind period
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
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?"
Measured: 14 days double-blind and 14 days open-label
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
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?"
Measured: 14-day double-blind and 14-day open-label
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
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?"
Measured: 14-day double-blind and 14-day open-label
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
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?"
Measured: 14 days double-blind and 14 days open-label
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 372 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00833638
- Sponsor's protocol ID
- 12719
- Other IDs
- H6D-US-LVHZ
- Status last verified
- Aug 2010
- First submitted
- 30 Jan 2009
- Last updated
- 24 Aug 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tadalafil 2.5 mg and 5 mg Once a Day Compared to Placebo in Day of Onset of Efficacy
- ClinicalTrials.gov ID
- NCT00833638
- Acronym / sponsor ID
- 12719
- Conditions
- Erectile Dysfunction
- Keywords
- Erectile Dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 372 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 2 Feb 2009 (estimated)
- Results
- Posted 18 Aug 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the day of onset of efficacy of tadalafil dosed once-a-day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tadalafil 2.5 mg | Experimental | Drug: TadalafilNo drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days. |
| Tadalafil 5 mg | Experimental | Drug: TadalafilNo drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days. |
| Placebo | Placebo comparator | Drug: Placebo, Drug: TadalafilNo drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboOne tablet orally daily | Drug | Placebo |
| TadalafilAlso: Cialis, LY450190Orally once daily | Drug | Placebo, Tadalafil 2.5 mg, Tadalafil 5 mg |
Primary outcome
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
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.
11 secondary outcomes
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
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
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
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
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
Sexual Encounter Profile Diary Question 3, the Overall Distribution of Time to Onset by Yes Responses
Time frame: 4 days double-blind period
Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts
Time frame: 14 days during double-blind period
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
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tadalafil in people with Erectile Dysfunction, run by Eli Lilly and Company at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2010.