Changes in Breast 3D Ultrasound Measurements Using Toremifene

Circulatory; Change Clinical Trial

Official title:

Volume and Circulation Changes of The Breast in 3D Ultrasound During Toremifene Versus Nonmedicated Menstrual Cycle

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01417754
• Other study ID #: Tore3D
• Status: Completed
• Phase: Phase 3
• First received: July 28, 2011
• Last updated: August 22, 2011
• Start date: September 2010
• Est. completion date: June 2011

Study information

• Verified date: August 2011
• Source: Satakunta Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Description:

20 women were participated to this trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Circulatory; Change

Intervention

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

Locations

Country	Name	City	State
Finland	Porin Lääkäritalo	Pori

Sponsors (3)

Lead Sponsor	Collaborator
Satakunta Central Hospital	Tampere University Hospital, University of Tampere

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	circulation changes of the breast		cycle day 23 to 26	No