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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
10
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.
tablet equal to toremifene, one tablet daily from cycle day 15 to menstruation during three cycles
Satakunta Central hospital, department of gynaecology and obstetrics
Pori, Finland
the effects to the MRI findings
Time frame: after three cycles toremifene and placebo plus wash-out cycle, seven months
magnetic resonance imaging changes
Time frame: seven months
cyclic breast pain relief, quality of life, acceptability of treatment
Time frame: seven months
breast pain
Time frame: seven months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.