CompletedNCT00444548Updated Jun 1, 2011

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

An interventional study of [S,S]-Reboxetine in Healthy, sponsored by Pfizer. Completed at 1 site in Denmark. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-06-01.

Sponsored by Pfizer · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 12
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: Female

Study summary

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

Conditions studied

Healthy

Keywords

Equipment
Supplies

In context

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: Female
Accepts healthy volunteers: Yes

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

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double
Enrollment: 12 participants (actual)

Interventions

Drug[S,S]-Reboxetine

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

1 site

Pfizer Investigational Site
Hellerup, 2900, Denmark

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 1, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00444548
Lead sponsor: Pfizer
First posted: Mar 8, 2007
Start date: May 2007
Completion: Jul 2007
Last update: Jun 1, 2011

Study contacts

Pfizer CT.gov Call Center

study director · Pfizer

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2011. You cannot join it, but the record below documents what was studied.

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