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

This study has been completed.

First Received: March 6, 2007 Last Updated: August 20, 2007 History of Changes

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00444548

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

Drug Information available for: Reboxetine Reboxetine mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacodynamics Study
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

Estimated Enrollment:	24
Study Start Date:	March 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

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:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	A6061028
Study First Received:	March 6, 2007
Last Updated:	August 20, 2007
ClinicalTrials.gov Identifier:	NCT00444548 History of Changes
Health Authority:	Danish Dataprotection Agency, Danish Medicines Agency and Ethics Committee Denmark:

Keywords provided by Pfizer:

Equipment
Supplies

Study placed in the following topic categories:

Neurotransmitter Agents
Adrenergic Agents
Psychotropic Drugs

Healthy
Antidepressive Agents
Reboxetine

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Therapeutic Uses

Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Agents
Pharmacologic Actions
Antidepressive Agents
Reboxetine

ClinicalTrials.gov processed this record on May 06, 2009