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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-004633-15 | EudraCT Number |
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The greenlight laser has an absorption maximum which is exactly the same as for hemoglobin. In the presence of hemoglobin, its application causes vaporization of the tissue and this effect depends on the concentration of hemoglobin in the respective tissue. Therefore, increase of blood-flow in the tissue (here: prostate gland) should exert better efficacy of the laser application and consequently shortening of the required duration of laser application.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vardenafil (Levitra, BAY38-9456) | Experimental | One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before Greenlight(TM) laser ablation of prostate commenced. |
|
| Placebo | Placebo Comparator | One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before Greenlight(TM) laser ablation of prostate commenced. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vardenafil (Levitra, BAY38-9456) | Drug | One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before Greenlight(TM) laser ablation of prostate commenced. |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline-adjusted Least Squared (LS) Means of Peak Urinary Flow (Qmax) at 3 Months After Surgery or Last Observation Carried Forward (LOCF) | Baseline (pre-surgery Day -1) adjusted least squares (LS)-means at 3 months after surgery (Day +90, last observation carried forward (LOCF)) in peak urinary flow. | baseline and up to 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline-adjusted Least Squared (LS) Means of International Prostate Symptom Score (IPSS) Total Score at 3 Months After Surgery or Last Observation Carried Forward (LOCF) | Baseline (pre-surgery Day -1) adjusted LS-means at 3 months after surgery (Day +90, LOCF) in IPSS total score. IPSS is a questionnaire on benign prostate hyperplasia, including seven 6-point items on symptoms and one 7-point item on quality of life. Total score: sum of items 1 through 7; minimum: 0 (best); maximum: 41 (worst). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heidelberg | Baden-Wurttemberg | 69112 | Germany |
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| Label | URL |
|---|---|
| Click here and search for Bayer Product information by EMA | View source |
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Number of subjects enrolled, randomized and exposed to at least one dose (safety population): 50. Number of subjects who had undergone surgery, whose type of surgery (Greenlight(TM) laser-ablation) had not changed, energy consumption during surgery reported and who had taken the second dose on the day of surgery (intent-to-treat population): 44
Enrollment started on 19 March 2007 and the last study visit occurred on 02 June 2008. The study was conducted at one center, a university clinic in Germany.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vardenafil (Levitra, BAY38-9456) | One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences. |
| FG001 | Placebo | One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vardenafil (Levitra, BAY38-9456) | One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Baseline-adjusted Least Squared (LS) Means of Peak Urinary Flow (Qmax) at 3 Months After Surgery or Last Observation Carried Forward (LOCF) | Baseline (pre-surgery Day -1) adjusted least squares (LS)-means at 3 months after surgery (Day +90, last observation carried forward (LOCF)) in peak urinary flow. | The intent-to-treat (ITT) population includes participants with baseline and post-baseline measurement of peak urinary flow; imputation technique: last post-baseline observation carried forward (LOCF). The ITT population is not identical to the number of subjects who "completed" the study, as displayed under Participants Flow. | Posted | Mean | Standard Deviation | milliliter per second (mL/s) | baseline and up to 3 months after surgery |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vardenafil (Levitra, BAY38-9456) | One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | BAYER | clinical-trials-contact@bayerhealthcare.com |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000069058 | Vardenafil Dihydrochloride |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before Greenlight(TM) laser ablation of prostate commenced. |
|
| baseline and up to 3 months after surgery |
| Baseline-adjusted Least Squared (LS) Means of Post-void Residual (PVR) Volume at 3 Months After Surgery or Last Observation Carried Forward (LOCF) | Baseline (pre-surgery Day -1) adjusted LS-means at 3 months after surgery (Day +90, last observation carried forward (LOCF)) in PVR volume. PVR is the amount of urine left in the bladder after a person has passed urine. | baseline and up to 3 months after surgery |
| Baseline-adjusted Least Squared (LS) Means of the Number of Urinary Incontinence Episodes Per Week at 3 Months After Surgery or Last Observation Carried Forward (LOCF) | Baseline (pre-surgery Day -1) adjusted LS-means at 3 months after surgery (Day +90, last observation carried forward (LOCF)) in the number of incontinence episodes. Urinary incontinence is an involuntary excretion (passing) of urine. Urinary incontinence episodes were collected in the patient diary. | baseline and up to 3 months after surgery |
| Duration of Surgery | Duration of prostate laser ablation, i.e. Greenlight(TM) laser surgery. | on the day of surgery, without any further allowable time window |
| Protocol Violation |
|
| Withdrawal by Subject |
|
One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Placebo | One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences |
|
|
|
| Secondary | Baseline-adjusted Least Squared (LS) Means of International Prostate Symptom Score (IPSS) Total Score at 3 Months After Surgery or Last Observation Carried Forward (LOCF) | Baseline (pre-surgery Day -1) adjusted LS-means at 3 months after surgery (Day +90, LOCF) in IPSS total score. IPSS is a questionnaire on benign prostate hyperplasia, including seven 6-point items on symptoms and one 7-point item on quality of life. Total score: sum of items 1 through 7; minimum: 0 (best); maximum: 41 (worst). | The intent-to-treat (ITT) population includes participants with baseline and post-baseline measurement of International Prostate Symptom Score (IPSS) total score; imputation technique: last post-baseline observation carried forward (LOCF). The ITT population is not identical to the number of subjects who "completed" the study. | Posted | Mean | Standard Deviation | scores on a scale | baseline and up to 3 months after surgery |
|
|
|
|
| Secondary | Baseline-adjusted Least Squared (LS) Means of Post-void Residual (PVR) Volume at 3 Months After Surgery or Last Observation Carried Forward (LOCF) | Baseline (pre-surgery Day -1) adjusted LS-means at 3 months after surgery (Day +90, last observation carried forward (LOCF)) in PVR volume. PVR is the amount of urine left in the bladder after a person has passed urine. | The intent-to-treat (ITT) population includes participants with baseline and post-baseline measurement of post-void residual (PVR) volume; imputation technique: last post-baseline observation carried forward (LOCF). The ITT population is not identical to the number of subjects who "completed" the study. | Posted | Mean | Standard Deviation | milliliter (mL) | baseline and up to 3 months after surgery |
|
|
|
|
| Secondary | Baseline-adjusted Least Squared (LS) Means of the Number of Urinary Incontinence Episodes Per Week at 3 Months After Surgery or Last Observation Carried Forward (LOCF) | Baseline (pre-surgery Day -1) adjusted LS-means at 3 months after surgery (Day +90, last observation carried forward (LOCF)) in the number of incontinence episodes. Urinary incontinence is an involuntary excretion (passing) of urine. Urinary incontinence episodes were collected in the patient diary. | The intent-to-treat (ITT) population includes participants with baseline and post-baseline documentation of number of incontinence episodes per week; imputation technique: last post-baseline observation carried forward (LOCF). The ITT population is not identical to the number of subjects who "completed" the study. | Posted | Mean | Standard Deviation | urinary incontinence episodes | baseline and up to 3 months after surgery |
|
|
|
|
| Secondary | Duration of Surgery | Duration of prostate laser ablation, i.e. Greenlight(TM) laser surgery. | The intent-to-treat (ITT) population includes participants with baseline and post-baseline measurement of duration of surgery; imputation technique: last post-baseline observation carried forward (LOCF). The ITT population is not identical to the number of subjects who "completed" the study. | Posted | Mean | Standard Deviation | minutes | on the day of surgery, without any further allowable time window |
|
|
|
|
| 1 |
| 25 |
| 2 |
| 25 |
| EG001 | Placebo | One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences | 2 | 25 | 2 | 25 |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 11.1 | Non-systematic Assessment |
|
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| D052801 |
| Male Urogenital Diseases |
| D010879 |
| Piperazines |