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

Breast Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00534846
• Other study ID #: tore20mg
• Secondary ID: EudraCT 2006-006
• Status: Completed
• Phase: Phase 3
• First received: September 24, 2007
• Last updated: May 12, 2009
• Start date: April 2007
• Est. completion date: February 2009

Study information

• Verified date: May 2009
• Source: Satakunta Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2009
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Pain

Intervention

Drug:
• toremifene
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.
• placebo
tablet equal to toremifene, one tablet daily from cycle day 15 to menstruation during three cycles

Locations

Country	Name	City	State
Finland	Satakunta Central hospital, department of gynaecology and obstetrics	Pori

Sponsors (2)

Lead Sponsor	Collaborator
Satakunta Central Hospital	University of Tampere

Country where clinical trial is conducted

Finland, 

References & Publications (1)

Oksa S, Luukkaala T, Mäenpää J. Toremifene for premenstrual mastalgia: a randomised, placebo-controlled crossover study. BJOG. 2006 Jun;113(6):713-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the effects to the MRI findings		after three cycles toremifene and placebo plus wash-out cycle, seven months	No
Primary	magnetic resonance imaging changes		seven months	Yes
Secondary	cyclic breast pain relief, quality of life, acceptability of treatment		seven months	No
Secondary	breast pain		seven months	No