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Changes in Breast 3D Ultrasound Measurements Using Toremifene

This study has been completed.
Tampere University Hospital
University of Tampere
Information provided by (Responsible Party):
SINIKKA OKSA, Satakunta Central Hospital Identifier:
First received: July 28, 2011
Last updated: August 22, 2011
Last verified: August 2011
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 Intervention Phase
Circulatory; Change Drug: Toremifene Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by SINIKKA OKSA, Satakunta Central Hospital:

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

Enrollment: 20
Study Start Date: September 2010
Study Completion Date: June 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:
20 women were participated to this trial.

Ages Eligible for Study:   25 Years to 45 Years   (Adult)
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
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Please refer to this study by its identifier: NCT01417754

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

Responsible Party: SINIKKA OKSA, MD, principal investigator, Satakunta Central Hospital Identifier: NCT01417754     History of Changes
Other Study ID Numbers: Tore3D
Study First Received: July 28, 2011
Last Updated: August 22, 2011

Keywords provided by SINIKKA OKSA, Satakunta Central Hospital:

Additional relevant MeSH terms:
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 processed this record on September 21, 2017