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NCT00165204 · ClinicalTrials.gov registry record · Phase 2

Effects of Tibilone on Bone Density, Menopause Symptoms and Breast Density in Women After Prophylactic Oophorectomy

A Phase 2 study of Breast Cancer and Menopause, sponsored by Dana-Farber Cancer Institute.

Completed
Registry status
Phase 2
Development phase
50
Enrollment target
3
Study locations

NCT00165204 is a Phase 2 study of Breast Cancer and Menopause that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 50 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 3 study locations across 1 state.

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The verdict

NCT00165204, a Phase 2 study of Breast Cancer and Menopause, has completed, sponsored by Dana-Farber Cancer Institute.

COMPLETED
Registry status
Phase 2
Development phase
50 participants
Enrollment target
3
Study locations

Study Summary

Women undergoing surgical menopause often experience marked menopausal side effects but are reluctant to use estrogen or other female hormones to ease the transition to menopause because of worries that the hormones may increase breast cancer risks. This study will evaluate tibolone in women experiencing surgical menopause to assess its effects on bone health, menopause symptoms and breast density.

Interventions

  • DRUG Tibolone

Study Locations (3)

Massachusetts

  • Massachusetts General Hospital - Boston
  • Dana-Farber Cancer Institute - Boston
  • Beth Israel Deaconess Medical Center - Boston

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2004-04
Est. Completion 2006-03
Phase Phase 2

Sponsor

Dana-Farber Cancer Institute

781 total trials

What the Registry Record Tells You About NCT00165204

The ClinicalTrials.gov registry entry for NCT00165204 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The listed sponsor is Dana-Farber Cancer Institute, which has 781 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Tibolone is the first listed.

NCT00165204 reports 3 study locations spanning 1 distinct geographic area - top geographies include Massachusetts.

Frequently Asked Questions

What is clinical trial NCT00165204 about?

NCT00165204 is a clinical study titled "Effects of Tibilone on Bone Density, Menopause Symptoms and Breast Density in Women After Prophylactic Oophorectomy". Women undergoing surgical menopause often experience marked menopausal side effects but are reluctant to use estrogen or other female hormones to ease the transition to menopause because of worries that the hormones may increase breast cancer risks. This study will evaluate tibolone in women experie...

What is the current status of trial NCT00165204?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2004-04. Estimated completion is 2006-03.

What conditions does trial NCT00165204 study?

This clinical trial studies the following conditions: Breast Cancer, Menopause, Postmenopausal Bone Loss.

What interventions are being tested in trial NCT00165204?

The interventions under investigation include: Tibolone (DRUG).

Who is sponsoring clinical trial NCT00165204?

This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00165204 being conducted?

This trial has 3 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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