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NCT00604825 · ClinicalTrials.gov registry record · Phase 2

Treatment Of Hot Flashes/Flushes In Postmenopausal Women (WARM Study)

A Phase 2 study of Menopausal and Female Climacteric States, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 2
Development phase
356
Enrollment target
20
Study locations

NCT00604825: Completed Phase 2 study of Menopausal and Female Climacteric States, sponsored by GlaxoSmithKline.

NCT00604825 is a Phase 2 study of Menopausal and Female Climacteric States that has completed, run by GlaxoSmithKline. The registered enrollment target is 356 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (168% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00604825, a Phase 2 study of Menopausal and Female Climacteric States, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 2
Development phase
356 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to determine whether GSK232802 is safe and effective in reducing the frequency and severity of hot flashes associated with menopause.

Primary Outcome

AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected bene

Interventions

  • DRUG Other: Placebo
  • DRUG GSK232802
  • DRUG PREMARIN

Study Locations (20)

Florida

  • GSK Investigational Site - Crystal River
  • GSK Investigational Site - Fort Myers
  • GSK Investigational Site - Jacksonville
  • GSK Investigational Site - Miami
  • GSK Investigational Site - Pinellas Park

Arizona

  • GSK Investigational Site - Chandler
  • GSK Investigational Site - Glendale
  • GSK Investigational Site - Scottsdale
  • GSK Investigational Site - Tucson

Colorado

  • GSK Investigational Site - Aurora
  • GSK Investigational Site - Boulder
  • GSK Investigational Site - Denver
  • GSK Investigational Site - Wheat Ridge

California

  • GSK Investigational Site - Poway
  • GSK Investigational Site - San Diego
  • GSK Investigational Site - San Diego

Georgia

  • GSK Investigational Site - Atlanta
  • GSK Investigational Site - Savannah

District of Columbia

  • GSK Investigational Site - Washington D.C.

Kansas

  • GSK Investigational Site - Overland Park

Trial Details

FieldValue
Enrollment Target 356 participants
Start Date 2007-07-17
Est. Completion 2008-07-23
Phase Phase 2
GlaxoSmithKline

1,345 total trials

What the finished NCT00604825 record still lists

NCT00604825 is an interventional study that assigns participants to a tested intervention. The registered 356 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (168% higher).

The record links to 1 condition, with Menopausal and Female Climacteric States appearing as the primary indexed condition, and to 3 interventions - of which Other: Placebo is the first listed.

NCT00604825 names 20 study sites across 7 states, led by Florida, Arizona, Colorado.

Frequently Asked Questions

What is clinical trial NCT00604825 about?

NCT00604825 is a clinical study titled "Treatment Of Hot Flashes/Flushes In Postmenopausal Women (WARM Study)". The purpose of this study is to determine whether GSK232802 is safe and effective in reducing the frequency and severity of hot flashes associated with menopause.

What is the current status of trial NCT00604825?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 356 participants. The study started on 2007-07-17. Estimated completion is 2008-07-23.

What conditions does trial NCT00604825 study?

This clinical trial studies the following conditions: Menopausal and Female Climacteric States.

What interventions are being tested in trial NCT00604825?

The interventions under investigation include: Other: Placebo (DRUG), GSK232802 (DRUG), PREMARIN (DRUG).

Who is sponsoring clinical trial NCT00604825?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00604825 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT00604825's enrollment target sits among peer trials

356 128th of 2000 higher than 1,873 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00604825, the US trial registry maintained by the National Library of Medicine. NCT00604825 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.