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NCT00343382 · ClinicalTrials.gov registry record · Phase 3

Pilocarpine in Treating Vaginal Dryness in Patients With Breast Cancer

A Phase 3 study, sponsored by Alliance for Clinical Trials in Oncology.

Completed
Registry status
Phase 3
Development phase
201
Enrollment target

NCT00343382: Completed Phase 3 study, sponsored by Alliance for Clinical Trials in Oncology.

NCT00343382 is a Phase 3 study that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 201 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00343382, a Phase 3 study, has completed, sponsored by Alliance for Clinical Trials in Oncology.

COMPLETED
Registry status
Phase 3
Development phase
201 participants
Enrollment target

Study Summary

RATIONALE: Pilocarpine may decrease vaginal dryness and improve quality of life in patients with breast cancer It is not yet known whether pilocarpine is more effective than a placebo in treating vaginal dryness in patients with breast cancer. PURPOSE: This randomized phase III trial is studying pilocarpine to see how well it works compared to a placebo in treating vaginal dryness in patients with breast cancer.

Primary Outcome

Vaginal dryness was measured by the numerical analogue scale at baseline and through the six weeks of treatment. The item scores was transformed into 0 to 100 scales with 0=poor quality of life (QOL) and 100=best possible QOL. The average AUC values were calculated by dividing 6 from AUC values for participants who completed item on all 6 weeks. If a participant completed the item at baseline, week 1, 2 and 3 but did not complete the item at week 4 to week 6, the AUC values of the item was prora

Interventions

  • OTHER placebo
  • DRUG pilocarpine hydrochloride

Trial Details

FieldValue
Enrollment Target 201 participants
Start Date 2006-12
Est. Completion 2012-12
Phase Phase 3

What the finished NCT00343382 record still lists

NCT00343382 is an interventional study that assigns participants to a tested intervention. The registered 201 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower).

The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.

NCT00343382 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00343382 about?

NCT00343382 is a clinical study titled "Pilocarpine in Treating Vaginal Dryness in Patients With Breast Cancer". RATIONALE: Pilocarpine may decrease vaginal dryness and improve quality of life in patients with breast cancer It is not yet known whether pilocarpine is more effective than a placebo in treating vaginal dryness in patients with breast cancer. PURPOSE: This randomized phase III trial is studying pi...

What is the current status of trial NCT00343382?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 201 participants. The study started on 2006-12. Estimated completion is 2012-12.

What interventions are being tested in trial NCT00343382?

The interventions under investigation include: placebo (OTHER), pilocarpine hydrochloride (DRUG).

Who is sponsoring clinical trial NCT00343382?

This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00343382's enrollment target sits among peer trials

201 1353rd of 2000 higher than 648 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00343382, the US trial registry maintained by the National Library of Medicine. NCT00343382 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.