Changes in Breast 3D Ultrasound Measurements Using Toremifene

August 22, 2011 updated by: SINIKKA OKSA, Satakunta Central Hospital

Volume and Circulation Changes of The Breast in 3D Ultrasound During Toremifene Versus Nonmedicated Menstrual Cycle

To investigate if there are detectable changes in volume and circulation in breasts of healthy volunteers using toremifene 20 mg in luteal phase of the menstruation cycle versus nonmedicated cycle.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

20 women were participated to this trial.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Pori, Finland, 28100
        • Porin Lääkäritalo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • age 25-45 healthy person
  • regular menstrual cycles
  • safe contraception(for example sterilization or condom)

Exclusion Criteria:

  • gynecological or other type of cancer
  • hormonal contraception
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Toremifene
Drug: Toremifene
20mg toremifene per day in tablet form starting from the cycle day 15 and continued to premenstrual period. Medication using about 10 days per volunteer
Other Names:
  • trade name Fareston

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
circulation changes of the breast
Time Frame: cycle day 23 to 26
cycle day 23 to 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Satakunta Central Hospital

Collaborators

Tampere University
Tampere University Hospital

Investigators

  • Study Director: Johanna Mäenpää, professor, Tampere University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (ACTUAL)

November 1, 2010

Study Completion (ACTUAL)

June 1, 2011

Study Registration Dates

First Submitted

July 28, 2011

First Submitted That Met QC Criteria

August 15, 2011

First Posted (ESTIMATE)

August 16, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 23, 2011

Last Update Submitted That Met QC Criteria

August 22, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tore3D

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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