We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Changes in Breast 3D Ultrasound Measurements Using Toremifene

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01417754
First Posted: August 16, 2011
Last Update Posted: August 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Tampere University Hospital
University of Tampere
Information provided by (Responsible Party):
SINIKKA OKSA, Satakunta Central Hospital
  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
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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Responsible Party: SINIKKA OKSA, MD, principal investigator, Satakunta Central Hospital
ClinicalTrials.gov Identifier: NCT01417754     History of Changes
Other Study ID Numbers: Tore3D
First Submitted: July 28, 2011
First Posted: August 16, 2011
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