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NCT00467493 · ClinicalTrials.gov registry record · Phase 2

Partial Double-Blind, Placebo-Controlled Study to Assess the Effect of Anastrozole on the Endometrium in Healthy Volunteers

A Phase 2 study of Menstruation Disorders, sponsored by Meditrina Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
64
Enrollment target
2
Study locations

NCT00467493 is a Phase 2 study of Menstruation Disorders that has completed, run by Meditrina Pharmaceuticals. The registered enrollment target is 64 participants. The trial reports 2 study locations across 1 state.

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The verdict

NCT00467493, a Phase 2 study of Menstruation Disorders, has completed, sponsored by Meditrina Pharmaceuticals.

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

Study Summary

Aromatase inhibitors have been approved for use in postmenopausal women to treat and prevent breast cancer. They act by blocking the action of the enzyme, aromatase, that is necessary for the production of estradiol. This class of drugs, aromatase inhibitors, are very effective in reducing estradiol levels in postmenopausal women and in treating estrogen receptor positive breast cancers. This study is examining the effect of a specific inhibitor, anastrozole, on endometrial thickness in premenopausal women. The endometrium is sensitive to estradiol and also has local aromatase which, if inhibited, may result in reduced endometrial thickness. The main hypothesis is that anastrozole can be administered at any time during the menstrual cycle and reduce endometrial thickness compared to placebo.

Conditions Studied

Interventions

  • DRUG Anastrozole

Study Locations (2)

Michigan

  • Jasper Research Clinic - Kalamazoo
  • University Women's Care - Southfield

Trial Details

FieldValue
Enrollment Target 64 participants
Start Date 2007-03
Est. Completion 2007-09
Phase Phase 2

Sponsor

Meditrina Pharmaceuticals

1 total trials

What the Registry Record Tells You About NCT00467493

The ClinicalTrials.gov registry entry for NCT00467493 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Meditrina Pharmaceuticals, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Menstruation Disorders appearing as the primary indexed condition, and to 1 intervention - of which Anastrozole is the first listed.

NCT00467493 reports 2 study locations spanning 1 distinct geographic area - top geographies include Michigan.

Frequently Asked Questions

What is clinical trial NCT00467493 about?

NCT00467493 is a clinical study titled "Partial Double-Blind, Placebo-Controlled Study to Assess the Effect of Anastrozole on the Endometrium in Healthy Volunteers". Aromatase inhibitors have been approved for use in postmenopausal women to treat and prevent breast cancer. They act by blocking the action of the enzyme, aromatase, that is necessary for the production of estradiol. This class of drugs, aromatase inhibitors, are very effective in reducing estradiol...

What is the current status of trial NCT00467493?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 64 participants. The study started on 2007-03. Estimated completion is 2007-09.

What conditions does trial NCT00467493 study?

This clinical trial studies the following conditions: Menstruation Disorders.

What interventions are being tested in trial NCT00467493?

The interventions under investigation include: Anastrozole (DRUG).

Who is sponsoring clinical trial NCT00467493?

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

Where is trial NCT00467493 being conducted?

This trial has 2 study locations across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.