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Changes in Breast 3D Ultrasound Measurements Using Toremifene

Sponsor
Satakunta Central Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01417754
Collaborator
Tampere University Hospital (Other), Tampere University (Other)
20
Enrollment
1
Location
1
Arm
9
Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

20 women were participated to this trial.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Volume and Circulation Changes of The Breast in 3D Ultrasound During Toremifene Versus Nonmedicated Menstrual Cycle
Study Start Date :
Sep 1, 2010
Actual Primary Completion Date :
Nov 1, 2010
Actual Study Completion Date :
Jun 1, 2011

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. circulation changes of the breast [cycle day 23 to 26]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Porin Lääkäritalo Pori Finland 28100

    Sponsors and Collaborators

    • Satakunta Central Hospital
    • Tampere University Hospital
    • Tampere University

    Investigators

    • Principal Investigator: Sinikka Oksa, MD, Satakunta Central Hospital
    • Study Director: Johanna Mäenpää, professor, Tampere University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    SINIKKA OKSA, MD, principal investigator, Satakunta Central Hospital
    ClinicalTrials.gov Identifier:
    NCT01417754
    Other Study ID Numbers:
    • Tore3D
    First Posted:
    Aug 16, 2011
    Last Update Posted:
    Aug 23, 2011
    Last Verified:
    Aug 1, 2011
    Keywords provided by SINIKKA OKSA, MD, principal investigator, Satakunta Central Hospital
    toremifene
    Additional relevant MeSH terms:
    Toremifene

    Study Results

    No Results Posted as of Aug 23, 2011