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NCT00084669 · ClinicalTrials.gov registry record · NA

Venlafaxine With or Without Zolpidem in Treating Hot Flashes and Associated Sleep Disorders in Women With Breast Cancer OR at High Risk for Developing Breast Cancer

A NA study, sponsored by Massachusetts General Hospital.

Completed
Registry status
NA
Development phase
119
Enrollment target

NCT00084669: Completed NA study, sponsored by Massachusetts General Hospital.

NCT00084669 is a NA study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 119 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT00084669, a NA study, has completed, sponsored by Massachusetts General Hospital.

COMPLETED
Registry status
NA
Development phase
119 participants
Enrollment target

Study Summary

RATIONALE: Venlafaxine may be effective in relieving hot flashes caused by hormone therapy. Giving venlafaxine with zolpidem (a sleeping pill) may improve sleep and quality of life in women who are receiving hormone therapy for treatment or prevention of breast cancer. PURPOSE: This randomized clinical trial is studying giving venlafaxine together with zolpidem to see how well it works compared to venlafaxine alone in relieving hot flashes and associated sleep disorders in women who are receiving hormone therapy to treat or prevent breast cancer.

Interventions

  • DRUG venlafaxine
  • PROCEDURE management of therapy complications
  • DRUG zolpidem tartrate

Trial Details

FieldValue
Enrollment Target 119 participants
Start Date 2004-05
Est. Completion 2010-03
Phase NA
Massachusetts General Hospital

2,032 total trials

What the finished NCT00084669 record still lists

NCT00084669 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 3 interventions - of which venlafaxine is the first listed.

NCT00084669 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00084669 about?

NCT00084669 is a clinical study titled "Venlafaxine With or Without Zolpidem in Treating Hot Flashes and Associated Sleep Disorders in Women With Breast Cancer OR at High Risk for Developing Breast Cancer". RATIONALE: Venlafaxine may be effective in relieving hot flashes caused by hormone therapy. Giving venlafaxine with zolpidem (a sleeping pill) may improve sleep and quality of life in women who are receiving hormone therapy for treatment or prevention of breast cancer. PURPOSE: This randomized clin...

What is the current status of trial NCT00084669?

This trial is currently completed. It is a NA study. The enrollment target is 119 participants. The study started on 2004-05. Estimated completion is 2010-03.

What interventions are being tested in trial NCT00084669?

The interventions under investigation include: venlafaxine (DRUG), management of therapy complications (PROCEDURE), zolpidem tartrate (DRUG).

Who is sponsoring clinical trial NCT00084669?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00084669's enrollment target sits among peer trials

119 803rd of 2000 higher than 1,198 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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 NCT00084669, the US trial registry maintained by the National Library of Medicine. NCT00084669 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.