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Changes in Breast 3D Ultrasound Measurements Using Toremifene

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ClinicalTrials.gov Identifier: NCT01417754
Recruitment Status : Completed
First Posted : August 16, 2011
Last Update Posted : August 23, 2011
Sponsor:
Collaborators:
Tampere University Hospital
University of Tampere
Information provided by (Responsible Party):
SINIKKA OKSA, Satakunta Central Hospital

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
Circulatory; Change Drug: Toremifene Phase 3

Detailed Description:
20 women were participated to this trial.

Study Type : Interventional  (Clinical Trial)
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 : September 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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 Name: trade name Fareston



Primary Outcome Measures :
  1. circulation changes of the breast [ Time Frame: cycle day 23 to 26 ]


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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01417754


Locations
Finland
Porin Lääkäritalo
Pori, Finland, 28100
Sponsors and Collaborators
Satakunta Central Hospital
Tampere University Hospital
University of Tampere
Investigators
Principal Investigator: Sinikka Oksa, MD Satakunta Central Hospital
Study Director: Johanna Mäenpää, professor Tampere University Hospital

Responsible Party: SINIKKA OKSA, MD, principal investigator, Satakunta Central Hospital
ClinicalTrials.gov Identifier: NCT01417754     History of Changes
Other Study ID Numbers: Tore3D
First Posted: August 16, 2011    Key Record Dates
Last Update Posted: August 23, 2011
Last Verified: August 2011

Keywords provided by SINIKKA OKSA, Satakunta Central Hospital:
toremifene

Additional relevant MeSH terms:
Toremifene
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents