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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Breast Pain

Intervention / Treatment
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* Drug: toremifene
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A placebo<br>The participants were randomly allocated to receive toremifene (20 mg) or placebo during the luteal phase for three consecutive menstrual cycles. | Drug: placebo<br>* tablet equal to toremifene, one tablet daily from cycle day 15 to menstruation during three cycles<br>|
| Active Comparator: B toremifene<br>The participants were randomly allocated to receive toremifene (20 mg) or placebo during the luteal phase for three consecutive menstrual cycles. | Drug: toremifene<br>* 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.<br>* Other names: cyclic breast pain;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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premenstrual syndrome, mastalgia, toremifene, selective estrogen receptor modulators