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NCT00219531 · ClinicalTrials.gov registry record

Effect of Menstrual Cycle on Central Nervous System (CNS) Processing of Gut Stimuli in Irritable Bowel Syndrome (IBS) and Control

A clinical trial, sponsored by Penn State University.

Terminated
Registry status
48
Enrollment target

NCT00219531: Clinical Trial study, sponsored by Penn State University.

NCT00219531 is a clinical trial that was terminated before completion, run by Penn State University. The registered enrollment target is 48 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00219531 was terminated before completion, sponsored by Penn State University.

TERMINATED
Registry status
48 participants
Enrollment target

Study Summary

The hypothesis of the study is that women perceive intestinal stimulation (rectal balloon distention) differently in different phases of the menstrual cycle, i.e there is an effect of hormones on the sensory pathway, and that this difference is reflected in the Central Nervous System processing of this signal. We also hypothesize that there is a difference in perception between control subjects and subjects with the irritable bowel syndrome.

Primary Outcome

pressure at which certain sensations are felt when barostat is inflated in the rectum during follicular and luteal phase of menstrual cycle

Interventions

  • BEHAVIORAL perception of rectal balloon distention

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 1999-03
Est. Completion 2015-02
Penn State University

219 total trials

Why NCT00219531 stopped before completion

NCT00219531 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 48 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which perception of rectal balloon distention is the first listed.

NCT00219531 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00219531 about?

NCT00219531 is a clinical study titled "Effect of Menstrual Cycle on Central Nervous System (CNS) Processing of Gut Stimuli in Irritable Bowel Syndrome (IBS) and Control". The hypothesis of the study is that women perceive intestinal stimulation (rectal balloon distention) differently in different phases of the menstrual cycle, i.e there is an effect of hormones on the sensory pathway, and that this difference is reflected in the Central Nervous System processing of t...

What is the current status of trial NCT00219531?

This trial is currently terminated. The enrollment target is 48 participants. The study started on 1999-03. Estimated completion is 2015-02.

What interventions are being tested in trial NCT00219531?

The interventions under investigation include: perception of rectal balloon distention (BEHAVIORAL).

Who is sponsoring clinical trial NCT00219531?

This trial is sponsored by Penn State University, which has 219 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT00219531, the US trial registry maintained by the National Library of Medicine. NCT00219531 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.