Clinical trial NCT00534846: The Effect of Toremifene Treatment to the Magnetic Resonance Imaging (MRI) Findings in Premenstrual Mastalgia
Official title: The Effect of Toremifene Treatment to the Magnetic Resonance Imaging Findings in Women Suffering From Premenstrual Mastalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Pain
Keywords: premenstrual syndrome
mastalgia
toremifene
selective estrogen receptor modulators
Lead sponsor: Satakunta Central Hospital
Sponsor class: OTHER
Collaborators: name: Tampere University
First posted: 2007-09-26
Enrollment: 10
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: the effects to the MRI findings
timeFrame: after three cycles toremifene and placebo plus wash-out cycle, seven months
measure: magnetic resonance imaging changes
timeFrame: seven months
Secondary outcomes:
measure: cyclic breast pain relief, quality of life, acceptability of treatment
timeFrame: seven months
measure: breast pain
timeFrame: seven months
Other outcomes:
Locations:
city: Pori
country: Finland
facility: Satakunta Central hospital, department of gynaecology and obstetrics
Study officials:
affiliation: Satakunta Central Hospital
name: SINIKKA OKSA, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tampere University Hospital
name: JOHANNA MÄENPÄÄ
role: STUDY_DIRECTOR
References:
citation: Oksa S, Luukkaala T, Maenpaa J. Toremifene for premenstrual mastalgia: a randomised, placebo-controlled crossover study. BJOG. 2006 Jun;113(6):713-8. doi: 10.1111/j.1471-0528.2006.00943.x.