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

Primary Purpose

Breast Pain

Status
Completed
Phase
Phase 3
Locations
Finland
Study Type
Interventional
Intervention
toremifene
placebo
Sponsored by
Satakunta Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Pain focused on measuring premenstrual syndrome, mastalgia, toremifene, selective estrogen receptor modulators

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Satakunta Central hospital, department of gynaecology and obstetrics

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

A placebo

B toremifene

Arm Description

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

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

Outcomes

Primary Outcome Measures

the effects to the MRI findings
magnetic resonance imaging changes

Secondary Outcome Measures

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

Full Information

First Posted
September 24, 2007
Last Updated
May 12, 2009
Sponsor
Satakunta Central Hospital
Collaborators
Tampere University
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1. Study Identification

Unique Protocol Identification Number
NCT00534846
Brief Title
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

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Satakunta Central Hospital
Collaborators
Tampere University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Pain
Keywords
premenstrual syndrome, mastalgia, toremifene, selective estrogen receptor modulators

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A placebo
Arm Type
Placebo Comparator
Arm Description
The participants were randomly allocated to receive toremifene (20 mg) or placebo during the luteal phase for three consecutive menstrual cycles.
Arm Title
B toremifene
Arm Type
Active Comparator
Arm Description
The participants were randomly allocated to receive toremifene (20 mg) or placebo during the luteal phase for three consecutive menstrual cycles.
Intervention Type
Drug
Intervention Name(s)
toremifene
Other Intervention Name(s)
magnetic resonance imaging, cyclic breast pain
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
tablet equal to toremifene, one tablet daily from cycle day 15 to menstruation during three cycles
Primary Outcome Measure Information:
Title
the effects to the MRI findings
Time Frame
after three cycles toremifene and placebo plus wash-out cycle, seven months
Title
magnetic resonance imaging changes
Time Frame
seven months
Secondary Outcome Measure Information:
Title
cyclic breast pain relief, quality of life, acceptability of treatment
Time Frame
seven months
Title
breast pain
Time Frame
seven months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SINIKKA OKSA, MD
Organizational Affiliation
Satakunta Central Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
JOHANNA MÄENPÄÄ
Organizational Affiliation
Tampere University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Satakunta Central hospital, department of gynaecology and obstetrics
City
Pori
ZIP/Postal Code
28500
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
16709215
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.
Results Reference
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The Effect of Toremifene Treatment to the Magnetic Resonance Imaging (MRI) Findings in Premenstrual Mastalgia

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