NCT00894517

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2009

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

September 30, 2013

Completed
Last Updated

September 30, 2013

Status Verified

July 1, 2013

Enrollment Period

2.8 years

First QC Date

May 5, 2009

Results QC Date

July 30, 2013

Last Update Submit

July 30, 2013

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

  • Percent Change in Total Sperm Count Per Ejaculate

    Sperm count per ejaculate was calculated based on the average of two semen samples collected 2 to 5 days apart at Baseline and at Week 12. Ejaculatory volume and sperm concentration were used to determine the total sperm count per ejaculate. A positive percent change from Baseline indicated improvement.

    Baseline, Week 12

Secondary Outcomes (4)

  • Change From Baseline in Log Transformed Sperm Concentration

    Baseline, Week 12

  • Change From Baseline in Ejaculatory Volume

    Baseline, Week 12

  • Change From Baseline in Total Sperm Motility

    Baseline, Week 12

  • Change From Baseline in Normal Sperm Morphology

    Baseline, Week 12

Study Arms (2)

Botulinum Toxin Type A

EXPERIMENTAL

OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.

Biological: Botulinum Toxin Type A

Placebo (saline)

PLACEBO COMPARATOR

Placebo (saline) injected into the prostate on Day 1.

Drug: Placebo (saline)

Interventions

Botulinum Toxin Type ABIOLOGICAL

OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.

Also known as: BOTOX®
Botulinum Toxin Type A
Placebo (saline)DRUG

Saline injected into the prostate on Day 1.

Placebo (saline)

Eligibility Criteria

Age45 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Los Angeles, California, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Botulinum Toxins, Type ASodium Chloride

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological FactorsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Results Point of Contact

Title
Therapeutic Area Head,
Organization
Allergan, Inc
clinicaltrials@allergan.com
714-246-4500

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2009

First Posted

May 7, 2009

Study Start

August 1, 2009

Primary Completion

June 1, 2012

Study Completion

August 1, 2012

Last Updated

September 30, 2013

Results First Posted

September 30, 2013

Record last verified: 2013-07

Locations

US(1)