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

This study has been completed.

Study NCT00461123 Information provided by Bayer

First Received on April 16, 2007. Last Updated on April 29, 2011 History of Changes

Results First Received: September 29, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Prostatic Hypertrophy, Benign
Interventions:	Drug: Levitra (Vardenafil, BAY38-9456) Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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

Reporting Groups

	Description
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.
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

Participant Flow: Overall Study

	Vardenafil (Levitra, BAY38-9456)	Placebo
STARTED	25	25
COMPLETED	19	19
NOT COMPLETED	6	6
Adverse Event	1	0
Lost to Follow-up	1	1
Protocol Violation	3	2
Withdrawal by Subject	1	3

Baseline Characteristics

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Reporting Groups

	Description
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.
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

Baseline Measures

	Vardenafil (Levitra, BAY38-9456)	Placebo	Total
Number of Participants [units: participants]	25	25	50
Age [units: years] Mean ± Standard Deviation	65.8 ± 7.5	65.9 ± 7.9	65.9 ± 7.6
Gender [units: participants]
Female	0	0	0
Male	25	25	50

Outcome Measures

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1. Primary:

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 ]

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2. 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) [ Time Frame: baseline and up to 3 months after surgery ]

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3. Secondary:

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 ]

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4. 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) [ Time Frame: baseline and up to 3 months after surgery ]

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5. Secondary:

Duration of Surgery [ Time Frame: on the day of surgery, without any further allowable time window ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Therapeutic Area Head
Organization: BAYER
e-mail: clinical-trials-contact@bayerhealthcare.com

No publications provided

Responsible Party:	Therapeutic Area Head, Bayer Vital GmbH
ClinicalTrials.gov Identifier:	NCT00461123 History of Changes
Other Study ID Numbers:	12496, EudraCT: 2006-004633-15
Study First Received:	April 16, 2007
Results First Received:	September 29, 2009
Last Updated:	April 29, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices