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OpenTrials
Completed

NCT Number: NCT00444548

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

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

Completed

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Pfizer Investigational Site

Hellerup, 2900, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

[S,S]-Reboxetine

Drug

Primary outcomes

  1. Reflectometry measurements at visit 2, 3, 4 , 5, 6 and 7.

Secondary outcomes

  1. Urethral pressure profile measurements at visit 2, 3, 4, 5, 6 and 7

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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.

Important dates

Study start
2007
Study completion
2007
First posted
Mar 8, 2007
Registry last updated
Jun 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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