The Effect of Toremifene Treatment to the Magnetic Resonance Imaging (MRI) Findings in Premenstrual Mastalgia

May 12, 2009 updated by: Satakunta Central Hospital

The Effect of Toremifene Treatment to the Magnetic Resonance Imaging Findings in Women Suffering From Premenstrual Mastalgia

The purpose of this study is to determine the effect of toremifene treatment to the MRI findings of the breast in women suffering from premenstrual mastalgia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Benign breast pain is a common complaint of women in western countries. As many as 41-69% of women reported having mastalgia sufficient to interfere with their daily routines. Approximately 8-10% of premenopausal women suffer monthly from moderate to severe breast pain.Tamoxifen has previously been found to be effective in reducing premenstrual mastalgia. We showed that another triphenylethylene derivative, toremifene, significantly alleviated cyclical breast pain as compared to placebo. In this study women suffering from cyclical breast pain are randomly allocated to receive toremifene (20mg) or placebo during the luteal phase for three consecutive cycles. The patients are then crossed over after a wash-out period to placebo or toremifene, respectively. The MRI investigations are made at two occasions during the premenstrual period after three cycles of toremifene and after three cycles of placebo.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Pori, Finland, 28500
        • Satakunta Central hospital, department of gynaecology and obstetrics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Premenstrual mastalgia
  • Age 20-45 years
  • Reliable non-hormonal contraception

Exclusion Criteria:

  • Pregnancy
  • Breast cancer or uterine corpus cancer
  • Unexplained menstrual disorders
  • Serious health problems
  • Hormonal contraception, including hormonal IUD trade name Mirena
  • Oestrogen and/or progestin treatment
  • Hysterectomy and/or oophorectomy or radiation therapy
  • Artificial cardiac pacemaker/metallic prostheses

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: A placebo
The participants were randomly allocated to receive toremifene (20 mg) or placebo during the luteal phase for three consecutive menstrual cycles.
tablet equal to toremifene, one tablet daily from cycle day 15 to menstruation during three cycles
Active Comparator: B toremifene
The participants were randomly allocated to receive toremifene (20 mg) or placebo during the luteal phase for three consecutive menstrual cycles.
The medication is given in tablet form, and the participants are instructed to take one tablet daily from cycle day 15 until the next menstruation. The active (toremifene 20 mg) and control (placebo) tablets were identical in appearance.
Other Names:
  • magnetic resonance imaging
  • cyclic breast pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the effects to the MRI findings
Time Frame: after three cycles toremifene and placebo plus wash-out cycle, seven months
after three cycles toremifene and placebo plus wash-out cycle, seven months
magnetic resonance imaging changes
Time Frame: seven months
seven months

Secondary Outcome Measures

Outcome Measure
Time Frame
cyclic breast pain relief, quality of life, acceptability of treatment
Time Frame: seven months
seven months
breast pain
Time Frame: seven months
seven months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Study Director: JOHANNA MÄENPÄÄ, Tampere University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

September 24, 2007

First Submitted That Met QC Criteria

September 24, 2007

First Posted (Estimate)

September 26, 2007

Study Record Updates

Last Update Posted (Estimate)

May 13, 2009

Last Update Submitted That Met QC Criteria

May 12, 2009

Last Verified

May 1, 2009

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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