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

Sponsor
Satakunta Central Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00534846
Collaborator
Tampere University (Other)
10
Enrollment
1
Location
2
Arms
22.1
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effect of Toremifene Treatment to the Magnetic Resonance Imaging Findings in Women Suffering From Premenstrual Mastalgia
Study Start Date :
Apr 1, 2007
Actual Primary Completion Date :
May 1, 2008
Actual Study Completion Date :
Feb 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: A placebo

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

Drug: placebo
tablet equal to toremifene, one tablet daily from cycle day 15 to menstruation during three cycles
Active Comparator: B toremifene

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

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.
Other Names:
  • magnetic resonance imaging
  • cyclic breast pain

    		•

    Outcome Measures

    Primary Outcome Measures

    1. the effects to the MRI findings [after three cycles toremifene and placebo plus wash-out cycle, seven months]

    2. magnetic resonance imaging changes [seven months]

    Secondary Outcome Measures

    1. cyclic breast pain relief, quality of life, acceptability of treatment [seven months]

    2. breast pain [seven months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Satakunta Central hospital, department of gynaecology and obstetrics Pori Finland 28500

    Sponsors and Collaborators

    • Satakunta Central Hospital
    • Tampere University

    Investigators

    • Principal Investigator: SINIKKA OKSA, MD, Satakunta Central Hospital
    • Study Director: JOHANNA MÄENPÄÄ, Tampere University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00534846
    Other Study ID Numbers:
    • tore20mg
    • EudraCT 2006-006109-97
    First Posted:
    Sep 26, 2007
    Last Update Posted:
    May 13, 2009
    Last Verified:
    May 1, 2009
    Keywords provided by , ,
    premenstrual syndrome
    mastalgia
    toremifene
    selective estrogen receptor modulators
    Additional relevant MeSH terms:
    Mastodynia
    Toremifene

    Study Results

    No Results Posted as of May 13, 2009