Evaluation of A Novel Methodology in the Assessment of Urethral Function Using [S,S]-Reboxetine in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00444548
First received: March 6, 2007
Last updated: May 31, 2011
Last verified: May 2011
  Purpose

[S,S]-Reboxetine will be used to evaluate pharmacodynamic changes in urethral function in healthy volunteers using a novel methodology


Condition Intervention
Healthy
Drug: [S,S]-Reboxetine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Measurement Of Urethral Function In Healthy Female Volunteers - Evaluation Of The Sensitivity of Urethral Reflectometry Compared To Urethral Pressure Profilometry, Using [S,S]-Reboxetine.

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Reflectometry measurements at visit 2, 3, 4 , 5, 6 and 7.

Secondary Outcome Measures:
  • Urethral pressure profile measurements at visit 2, 3, 4, 5, 6 and 7

Enrollment: 12
Study Start Date: May 2007
Study Completion Date: July 2007
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy female subjects, aged 18-65 years.
  • Subjects must be non-pregnant and non-lactating, and be either post menopausal (greater than 1 year without menses), surgically sterilized, or using another acceptable form of contraception.
  • Subjects of child bearing potential must have confirmed negative pregnancy tests at screening and prior to commencing all study periods.

Exclusion Criteria:

  • Evidence or history of clinically significant disease (including drug allergies, but excluding untreated, asymptomatic,seasonal allergies at time of dosing).
  • Subjects with any clinically significant abnormality following review of laboratory data, urinalysis and physical examination.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00444548

Locations
Denmark
Pfizer Investigational Site
Hellerup, Denmark, 2900
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00444548     History of Changes
Other Study ID Numbers: A6061028
Study First Received: March 6, 2007
Last Updated: May 31, 2011
Health Authority: Danish Dataprotection Agency, Danish Medicines Agency and Ethics Committee Denmark:

Keywords provided by Pfizer:
Equipment
Supplies

Additional relevant MeSH terms:
Reboxetine
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 01, 2014