Benign Prostatic HyperplasiaPhase 2NCT00540124
Pilot Study Investigating Safety and Efficacy of Tadalafil as Treatment for Benign Prostatic Hyperplasia (BPH) in Asian Men
A Phase 2 study testing Tadalafil and Tamsulosin in people with Benign Prostatic Hyperplasia, run by Eli Lilly and Company at 5 sites in South Korea.
Trial summary
The primary purpose of this clinical trial is to evaluate the change in the International Prostate Symptom Score (IPSS) total score from the beginning of the study to the end of the study for subjects randomized to tadalafil 5mg once a day dosing and placebo once a day dosing for 12 weeks of treatment. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Tadalafil and Tamsulosin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 151 participants
- Where
- 5 sitesSouth Korea
- Study dates
- Oct 2007to Jun 2008
- Phase
- Phase 2
- 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 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have Benign Prostatic Hyperplasia - Lower Urinary Tract Symptoms (BPH-LUTS) for at least 6 months prior to Visit 1.
- Agree not to use any other approved or experimental treatments for erectile dysfunction or BPH-LUTS during the study.
- Have not taken Finasteride therapy for at least 3 months prior to Visit 2.
- Have not taken Dutasteride therapy for at least 6 months prior to Visit 2.
- Have an International Prostate Symptom Score (IPSS) total score greater than or equal to 13 at Visit 2.
Who cannot join
- Prostate Specific Antigen (PSA) greater than 10.0 nanograms per milliliter (ng/mL) at Visit 1.
- Bladder Post Void Residual (PVR) greater than or equal to 300 mL by ultrasound at Visit 1.
- History of pelvic surgery, prostatectomy, radiotherapy, penile implant surgery, lower urinary tract malignancy or trauma.
- Urinary tract infection or inflammation or current antibiotic therapy for urinary tract infection at Visit 1.
- Glycosylated hemoglobin (HbA1c) greater than 9% at Visit 1.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
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.
Jeonju, 561-712
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.
Kwangju, 501-757
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.
Kyunggi-Do, 425-020
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.
Pusan, 614-735
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.
Seoul, 140-757
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Pilot Study to Evaluate the Efficacy and Safety of Tadalafil and Tamsulosin Once-a-Day Dosing for 12 Weeks in Asian Men With Signs and Symptoms of Benign Prostatic Hyperplasia
The primary purpose of this clinical trial is to evaluate the change in the International Prostate Symptom Score (IPSS) total score from the beginning of the study to the end of the study for subjects randomized to tadalafil 5mg once a day dosing and placebo once a day dosing for 12 weeks of treatment.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Tadalafil, Placebo, Tamsulosin
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TadalafilDrug
Also called LY450190, Cialis
5 mg once a day
PlaceboDrug
once a day
TamsulosinDrug
0.2 mg once a day
| Study group | Role | What they receive |
|---|---|---|
| Tadalafil | Experimental | Not described Receives: Drug: Tadalafil |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Tamsulosin | Active comparator | Not described Receives: Drug: Tamsulosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score
The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.
Measured: baseline, 12 weeks
Secondary outcomes (12)
Change From Baseline to 4 Week and 8 Week Endpoints in International Prostate Symptom Score (IPSS) Total Score
The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.
Measured: baseline, 4 and 8 weeks
Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Irritative Subscore
The IPSS storage (irritative) subscore is defined as sum of scores for Questions 2, 4, and 7 of the IPSS. If scores for any of these questions are missing for a visit, the IPSS storage subscore will be reported as missing for that visit. Subscore totals range from 0 to 15; higher scores are indicative of greater irritation.
Measured: baseline, 4, 8, and 12 weeks
Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Obstructive Subscore
The IPSS voiding (obstructive) subscore is defined as sum of scores for Questions 1, 3, 5, and 6 of the IPSS. If scores for any of these questions are missing for a visit, the IPSS voiding subscore will be reported as missing for that visit. Subscore totals range from 0 to 20; higher scores are indicative of greater obstruction.
Measured: baseline, 4, 8, and 12 weeks
Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Nocturia Subscore
IPSS Question 7 is used to assess the frequency of nocturia. Scores range from 0 (low frequency of nocturia) to 5 (high frequency of nocturia).
Measured: baseline, 4, 8, and 12 weeks
Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BPH-II)
The BPH-BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range of 0 to 13; higher scores represent increased perceived impact of BPH-LUTS on overall health. If scores for any component question were missing for a visit, BPH-BII was reported as missing for that visit.
Measured: baseline, 12 weeks
Patient Global Impression of Improvement (PGI-I) Combined Categories - Frequencies
A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). Scores were combined to provide number of participants who indicated they were "worse" (scores of 5, 6, or 7), "no change" (score of 4), or "better" (scores of 1, 2, or 3).
Measured: 12 weeks
Clinician Global Impression of Improvement (CGI-I) Combined Categories - Frequencies
Measures clinician's perception of patient improvement of illness at the time of assessment compared with start of treatment. Scores range from 1 (very much better) to 7 (very much worse). Scores were combined to provide number of participants whose clinician indicated they were "worse" (scores of 5, 6, or 7), "no change" (score of 4), or "better" (scores of 1, 2, or 3).
Measured: 12 weeks
Change From Baseline to 12 Week Endpoint in Total, Waking, and Sleeping Voids (Average Number Per Week) Based on Median as Reported in Patient Voiding Dribble Diary
Patient-completed diary that measures daytime frequency (waking voids) and nocturia (sleeping voids). Average number of waking voids per week, average number of sleeping voids per week, and average number of total voids (sleeping+waking) per week are reported.
Measured: baseline, 12 weeks
Change From Baseline to 12 Week Endpoint in Total Urinary Incontinence Episodes Per Week Based on Median as Reported in Patient Voiding Dribble Diary
A patient-completed diary that measures urinary incontinence (UI) (leaks). Number of UI leaks per week are reported.
Measured: baseline, 12 weeks
Change From Baseline to 12 Week Endpoint in Voids With Terminal Micturition Dribble and Post Micturition Dribble Per Week Based on Median as Reported by Patient Voiding Dribble Diary
A patient-completed diary that measures terminal dribble (dribble in the end of urination) and post-micturition dribble (dribble after urination).
Measured: baseline, 12 weeks
Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) and Mean Urine Flow Rate (Qmean)
Qmax: defined as the peak urine flow rate (measured in milliliters per second [mL/second] using a standard calibrated flowmeter); and Qmean, defined as the mean urine flow rate (measured in mL/second using a standard calibrated flowmeter).
Measured: baseline, 12 weeks
Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Voided Urine Volume (Vcomp)
Vcomp, defined as the volume of voided urine (measured in milliliters [mL]).
Measured: baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionJun 2008
- Study completionJun 2008
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 Benign Prostatic HyperplasiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 151 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
- NCT00540124
- Sponsor's protocol ID
- 11658
- Other IDs
- H6D-MC-LVHT
- Status last verified
- Nov 2010
- First submitted
- 3 Oct 2007
- Last updated
- 25 Nov 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 25 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Pilot Study to Evaluate the Efficacy and Safety of Tadalafil and Tamsulosin Once-a-Day Dosing for 12 Weeks in Asian Men With Signs and Symptoms of Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT00540124
- Acronym / sponsor ID
- 11658
- Conditions
- Benign Prostatic Hyperplasia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 5 Oct 2007 (estimated)
- Results
- Posted 20 Jul 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this clinical trial is to evaluate the change in the International Prostate Symptom Score (IPSS) total score from the beginning of the study to the end of the study for subjects randomized to tadalafil 5mg once a day dosing and placebo once a day dosing for 12 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tadalafil | Experimental | Drug: Tadalafil |
| Placebo | Placebo comparator | Drug: Placebo |
| Tamsulosin | Active comparator | Drug: Tamsulosin |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have Benign Prostatic Hyperplasia - Lower Urinary Tract Symptoms (BPH-LUTS) for at least 6 months prior to Visit 1.
- Agree not to use any other approved or experimental treatments for erectile dysfunction or BPH-LUTS during the study.
- Have not taken Finasteride therapy for at least 3 months prior to Visit 2.
- Have not taken Dutasteride therapy for at least 6 months prior to Visit 2.
- Have an International Prostate Symptom Score (IPSS) total score greater than or equal to 13 at Visit 2.
Key exclusion criteria (5 listed)
- Prostate Specific Antigen (PSA) greater than 10.0 nanograms per milliliter (ng/mL) at Visit 1.
- Bladder Post Void Residual (PVR) greater than or equal to 300 mL by ultrasound at Visit 1.
- History of pelvic surgery, prostatectomy, radiotherapy, penile implant surgery, lower urinary tract malignancy or trauma.
- Urinary tract infection or inflammation or current antibiotic therapy for urinary tract infection at Visit 1.
- Glycosylated hemoglobin (HbA1c) greater than 9% at Visit 1.
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 |
|---|---|---|
| TadalafilAlso: LY450190, Cialis5 mg once a day | Drug | Tadalafil |
| Placeboonce a day | Drug | Placebo |
| Tamsulosin0.2 mg once a day | Drug | Tamsulosin |
Primary outcome
Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score
Time frame: baseline, 12 weeks
The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.
12 secondary outcomes
Change From Baseline to 4 Week and 8 Week Endpoints in International Prostate Symptom Score (IPSS) Total Score
Time frame: baseline, 4 and 8 weeks
Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Irritative Subscore
Time frame: baseline, 4, 8, and 12 weeks
Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Obstructive Subscore
Time frame: baseline, 4, 8, and 12 weeks
Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Nocturia Subscore
Time frame: baseline, 4, 8, and 12 weeks
Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BPH-II)
Time frame: baseline, 12 weeks
Patient Global Impression of Improvement (PGI-I) Combined Categories - Frequencies
Time frame: 12 weeks
Clinician Global Impression of Improvement (CGI-I) Combined Categories - Frequencies
Time frame: 12 weeks
Change From Baseline to 12 Week Endpoint in Total, Waking, and Sleeping Voids (Average Number Per Week) Based on Median as Reported in Patient Voiding Dribble Diary
Time frame: baseline, 12 weeks
Change From Baseline to 12 Week Endpoint in Total Urinary Incontinence Episodes Per Week Based on Median as Reported in Patient Voiding Dribble Diary
Time frame: baseline, 12 weeks
Change From Baseline to 12 Week Endpoint in Voids With Terminal Micturition Dribble and Post Micturition Dribble Per Week Based on Median as Reported by Patient Voiding Dribble Diary
Time frame: baseline, 12 weeks
Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) and Mean Urine Flow Rate (Qmean)
Time frame: baseline, 12 weeks
Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Voided Urine Volume (Vcomp)
Time frame: baseline, 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 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
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tadalafil and Tamsulosin in people with Benign Prostatic Hyperplasia, run by Eli Lilly and Company at 5 sites in South Korea.
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 5 inclusion and 5 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 25 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 20 Jul 2009). 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?
Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score (time frame: baseline, 12 weeks). 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 25 Nov 2010.