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

Not Applicable

Completed

• Conditions: Healthy

• Registration Number: NCT00444548
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-03-06
• Study First Submitted QC: 2007-03-07
• Study First Posted: 2007-03-08
• Study Start: 2007-05
• Study Completion: 2007-07
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-31
• Last Update Posted: 2011-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Reflectometry measurements at visit 2, 3, 4 , 5, 6 and 7.

Secondary Outcome Measures

Name	Time	Method
Urethral pressure profile measurements at visit 2, 3, 4, 5, 6 and 7

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇩🇰 Hellerup, Denmark