Changes in Breast 3D Ultrasound Measurements Using Toremifene

This study has been completed.
Sponsor:
Collaborators:
Tampere University Hospital
University of Tampere
Information provided by (Responsible Party):
SINIKKA OKSA, Satakunta Central Hospital
ClinicalTrials.gov Identifier:
NCT01417754
First received: July 28, 2011
Last updated: August 22, 2011
Last verified: August 2011
  Purpose

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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: 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 Satakunta Central Hospital:

Primary Outcome Measures:
  • circulation changes of the breast [ Time Frame: cycle day 23 to 26 ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   25 Years to 45 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: SINIKKA OKSA, MD, principal investigator, Satakunta Central Hospital
ClinicalTrials.gov Identifier: NCT01417754     History of Changes
Other Study ID Numbers: Tore3D
Study First Received: July 28, 2011
Last Updated: August 22, 2011
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Satakunta Central Hospital:
toremifene

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

ClinicalTrials.gov processed this record on August 26, 2014