Prostatic Hypertrophy, BenignPhase 2NCT00461123

Vardenafil in Greenlight(TM) Laser Surgery of Benign Prostate Hypertrophy

A Phase 2 study testing Vardenafil (Levitra, BAY38-9456) in people with Prostatic Hypertrophy, Benign, run by Bayer at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years, men only
Conditions the study is for: Prostatic Hypertrophy, Benign
What is being tested?: Vardenafil (Levitra, BAY38-9456)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 50 participants
Where: 1 siteGermany
Study dates: Mar 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 18 to 80 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Men with benign prostate hypertrophy requiring surgical treatment
Age up to 80 years
Documented, dated, written Informed Consent
Anesthesiologists agreement with swallowing 1 tablet one hour prior surgery

Who cannot join

Any unstable medical, psychiatric, or substance abuse disorder
History of previous prostatectomy
Patients suspect of prostate cancer
Hereditary degenerative retinal disorder
History of previous Non-arteric Anterior Ischemic Optic Neuropathy (NAION) episode or unilateral vision impairment
Any cardiovascular condition

Show all 27Show fewer

History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months
Uncontrolled atrial fibrillation/flutter at screening
Severe chronic or acute liver disease
Chronic hematological disease which may lead to priapism
Bleeding disorder
Significant active peptic ulceration
Resting hypotension
History of positive test for Hepatitis B surface antigen or Hepatitis C
Symptomatic postural hypotension within 6 months of Visit 1
Patients who subjectively or in the opinion of the investigator did not tolerate the initial dose of study medication well
Subjects who are taking nitrates or nitric oxide donors
Subjects who are taking androgens or anti-androgens
Subjects who are taking potent inhibitors of cytochrome P4503A4
Subjects who have received any investigational drug within 30 days of Visit 1
Using of alpha-blockers during two days prior to first dosing of study medication and after ablation of prostate
Use of inhibitors of 5-alpha reductase after ablation of prostate
Subjects with serum creatinine clearance <30.0 mL/min
Elevation of Aspartate aminotransferase (AST) and/or Alanine aminotransferase (ALT) >3 times the upper limit of normal
Subjects with known hypersensitivity to Vardenafil
Subjects who are illiterate or unable to understand subject diaries
Subjects who would be non-compliant with the study visit schedule

Trial locations and contacts

1 site in 1 country.

Germany1 site

Study site
Heidelberg, Baden-Wurttemberg, 69112

Other trials in Germany

About this study

Official title: A Randomized, Double-blind, Parallel Group Prospective Pilot Study to Assess the Effect of Vardenafil on Clinical Outcome and on Procedure Duration After Green Light Laser-ablation of the Prostate Gland for Therapy of Benign Prostate Hypertrophy (BPH)

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.

Conditions: Prostatic Hypertrophy, Benign
Being tested: Vardenafil (Levitra, BAY38-9456), Placebo
Medical subject headings: Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.
PlaceboDrug
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.

Study groups in NCT00461123
Study group	Role	What they receive
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. Receives: Drug: Vardenafil (Levitra, BAY38-9456)
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. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: baseline and up to 3 months after surgery

Secondary outcomes (4)

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).
Measured: 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.
Measured: 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.
Measured: baseline and up to 3 months after surgery
Duration of Surgery
Duration of prostate laser ablation, i.e. Greenlight(TM) laser surgery.
Measured: on the day of surgery, without any further allowable time window

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2007Jun 2008

First posted17 Apr 2007 (estimated)
Study startMar 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 Prostatic Hypertrophy, BenignStudies of the same condition, open and under way.
More trials run by BayerThe 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: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00461123
Sponsor's protocol ID: 12496
Other IDs: 2006-004633-15
Status last verified: Dec 2014
First submitted: 16 Apr 2007
Last updated: 19 Dec 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
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Not yet recruitingPhase 4
Perioperative Dutasteride for Hemorrhage Control in Bipolar TURP Under Anticoagulation.
Benign Prostatic Hyperplasia, Postoperative Hemorrhage

All Prostatic Hypertrophy, Benign trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Parallel Group Prospective Pilot Study to Assess the Effect of Vardenafil on Clinical Outcome and on Procedure Duration After Green Light Laser-ablation of the Prostate Gland for Therapy of Benign Prostate Hypertrophy (BPH)
ClinicalTrials.gov ID: NCT00461123
Acronym / sponsor ID: 12496
Conditions: Prostatic Hypertrophy, Benign
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: BayerIndustry (pharma, biotech, devices)
Study start: Mar 2007
Primary completion: Jun 2008 (actual)
Study completion: Jun 2008 (actual)
First posted: 17 Apr 2007 (estimated)
Results: Posted 21 Jan 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Vardenafil (Levitra, BAY38-9456)	Experimental	Drug: 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 Greenlight(TM) laser ablation of prostate commenced.
Placebo	Placebo comparator	Drug: PlaceboOne 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.

Who may qualify

Ages: 18 to 80 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Men with benign prostate hypertrophy requiring surgical treatment
Age up to 80 years
Documented, dated, written Informed Consent
Anesthesiologists agreement with swallowing 1 tablet one hour prior surgery

Key exclusion criteria (27 listed)

Any unstable medical, psychiatric, or substance abuse disorder
History of previous prostatectomy
Patients suspect of prostate cancer
Hereditary degenerative retinal disorder
History of previous Non-arteric Anterior Ischemic Optic Neuropathy (NAION) episode or unilateral vision impairment

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
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 Greenlight(TM) laser ablation of prostate commenced.	Drug	Vardenafil (Levitra, BAY38-9456)
PlaceboOne 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.	Drug	Placebo

Primary outcome

Baseline-adjusted Least Squared (LS) Means of Peak Urinary Flow (Qmax) at 3 Months After Surgery or Last Observation Carried Forward (LOCF)
Time frame: baseline and up to 3 months after surgery
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.

4 secondary outcomes

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)
Time frame: 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)
Time frame: 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)
Time frame: baseline and up to 3 months after surgery
Duration of Surgery
Time frame: on the day of surgery, without any further allowable time window

Results and safety

Results posted to the registry on 21 Jan 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vardenafil (Levitra, BAY38-9456)	25	19
Placebo	25	19

Primary outcome: Baseline-adjusted Least Squared (LS) Means of Peak Urinary Flow (Qmax) at 3 Months After Surgery or Last Observation Carried Forward (LOCF)

Time frame: baseline and up to 3 months after surgery. Mean (Standard Deviation). Unit: milliliter per second (mL/s)

Measure	Vardenafil (Levitra, BAY38-9456) n = 19	Placebo n = 18
baseline mean	8.3 (4.08)	9.4 (5.69)
Day +90 or LOCF mean	23.1 (10.60)	25.7 (7.90)

Vardenafil (Levitra, BAY38-9456) vs Placebo: Mean Difference (Final Values): 1.93 (95% CI -4.18 to 8.05), p = 0.5248, ANCOVA

Population analysed: 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.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vardenafil (Levitra, BAY38-9456)	1 of 25 (4%)	2 of 25 (8%)	Not reported
Placebo	2 of 25 (8%)	2 of 25 (8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Click here and search for Bayer Product information by EMALink provided by the sponsor.

Related trials for Prostatic Hypertrophy, Benign

Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
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RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
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Not yet recruitingPhase 4
Perioperative Dutasteride for Hemorrhage Control in Bipolar TURP Under Anticoagulation.
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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.

Bayer Study Director study director

Bayer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vardenafil (Levitra, BAY38-9456) in people with Prostatic Hypertrophy, Benign, run by Bayer at 1 site in Germany.

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 4 inclusion and 27 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 19 Dec 2014. 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 Germany. 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 21 Jan 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?

Baseline-adjusted Least Squared (LS) Means of Peak Urinary Flow (Qmax) at 3 Months After Surgery or Last Observation Carried Forward (LOCF) (time frame: baseline and up to 3 months after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00461123.

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 19 Dec 2014.