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NCT Number: NCT00534846

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

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Key information

Conditions

Breast Pain Mastodynia Menstruation Disturbances Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Premenstrual Syndrome Signs and Symptoms

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Satakunta Central hospital, department of gynaecology and obstetrics

Pori, 28500, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Toremifene

Drug

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

Placebo

Drug

tablet equal to toremifene, one tablet daily from cycle day 15 to menstruation during three cycles

Primary outcomes

  1. the effects to the MRI findings

    Time frame: after three cycles toremifene and placebo plus wash-out cycle, seven months

  2. magnetic resonance imaging changes

    Time frame: seven months

Secondary outcomes

  1. cyclic breast pain relief, quality of life, acceptability of treatment

    Time frame: seven months

  2. breast pain

    Time frame: seven months

Sponsors and collaborators

Lead sponsor

Satakunta Central Hospital

Other

Collaborators

  • Tampere University

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Sep 26, 2007
Registry last updated
May 13, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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