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

Phase 3

Completed

• Conditions: Breast Pain
• Interventions: Drug: placebo; Drug: toremifene

• Registration Number: NCT00534846
• Lead Sponsor: Satakunta Central Hospital

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 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 Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-09-24
• Study First Submitted QC: 2007-09-24
• Study First Posted: 2007-09-26
• Primary Completion: 2008-05
• Study Completion: 2009-02
• Status Verified: 2009-05
• Last Update Submitted: 2009-05-12
• Last Update Posted: 2009-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A placebo	placebo	The participants were randomly allocated to receive toremifene (20 mg) or placebo during the luteal phase for three consecutive menstrual cycles.
B toremifene	toremifene	The participants were randomly allocated to receive toremifene (20 mg) or placebo during the luteal phase for three consecutive menstrual cycles.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
cyclic breast pain relief, quality of life, acceptability of treatment	seven months
breast pain	seven months

Trial Locations

Locations (1)

Satakunta Central hospital, department of gynaecology and obstetrics; 🇫🇮 Pori, Finland