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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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 Summary: 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.
Sponsor: Satakunta Central Hospital

Current Primary Outcome:

  • 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 ]


Original Primary Outcome: the effects to the MRI findings [ Time Frame: after three cycles toremifene and placebo ]

Current Secondary Outcome:

  • cyclic breast pain relief, quality of life, acceptability of treatment [ Time Frame: seven months ]
  • breast pain [ Time Frame: seven months ]


Original Secondary Outcome: cyclic breast pain relief, quality of life, acceptability of treatment [ Time Frame: during luteal phase of the menstrual cycle at baseline and at every treatment cycle ]

Information By: Satakunta Central Hospital

Dates:
Date Received: September 24, 2007
Date Started: April 2007
Date Completion:
Last Updated: May 12, 2009
Last Verified: May 2009