A Study Evaluating the Effect of Botulinum Toxin Type A on Semen Quality in Patients With Benign Prostatic Hyperplasia

This study is currently recruiting participants.

Verified August 2011 by Allergan

First Received on May 5, 2009. Last Updated on August 12, 2011 History of Changes

Sponsor:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00894517

Purpose

This is a 24 week study evaluating the effects of botulinum toxin type A on semen quality in patients with signs and symptoms of Benign Prostatic Hyperplasia (BPH).

Condition	Intervention	Phase
Benign Prostatic Hyperplasia	Biological: Botulinum Toxin Type A Biological: Placebo (saline)	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Botox

Drug Information available for: Botulinum toxin A Clostridium botulinum toxin

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Total sperm count per ejaculate (product of ejaculatory volume and sperm concentration). [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Ejaculatory volume [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Sperm concentration [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Total sperm motility [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Sperm morphology [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Estimated Enrollment:	58
Study Start Date:	August 2009
Estimated Study Completion Date:	January 2013
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Botulinum Toxin Type A	Biological: Botulinum Toxin Type A Botulinum Toxin Type A 200U injected into the prostate on day 1 Other Name: BOTOX®
Placebo Comparator: 2 Placebo (saline)	Biological: Placebo (saline) Saline injected into the prostate on day 1

Eligibility

Ages Eligible for Study:	45 Years to 70 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Symptoms due to an enlarged prostate
Able to provide semen samples at required visits.

Exclusion Criteria:

Previous use of any botulinum toxin for the treatment of any urological condition
History of vasectomy
History of undescended testicles or testicular trauma
Subject who has not ejaculated for greater than 1 year
History of prostate infection or any sexually transmitted disease, such as gonorrhea, within the previous 12 months
History of bladder stones
History of cancer in the prostate, testicles, or bladder
Previous use of chemotherapy for cancer treatment
History of urinary incontinence
Previous prostate surgery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00894517

Contacts

Contact: Allergan Inc

clinicaltrials@allergan.com

Locations

United States, California
	Recruiting
Los Angeles, California, United States

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

No publications provided

Responsible Party:	Therapeutic Area Head, Allergan, Inc.
ClinicalTrials.gov Identifier:	NCT00894517 History of Changes
Other Study ID Numbers:	191622-091
Study First Received:	May 5, 2009
Last Updated:	August 12, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Botulinum Toxins, Type A
Botulinum Toxins

Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012