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COMPLETED Phase 2

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

NCT00165204 · View on ClinicalTrials.gov ↗

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

819 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00165204

The ClinicalTrials.gov registry entry for NCT00165204 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dana-Farber Cancer Institute, which has 819 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00165204 reports 3 study locations spanning 1 distinct geographic area — top geographies include Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00165204?

The interventions under investigation include: Tibolone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00165204?

This trial is sponsored by Dana-Farber Cancer Institute, which has 819 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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