- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00534846
The Effect of Toremifene Treatment to the Magnetic Resonance Imaging (MRI) Findings in Premenstrual Mastalgia
May 12, 2009 updated by: Satakunta Central Hospital
The Effect of Toremifene Treatment to the Magnetic Resonance Imaging Findings in Women Suffering From 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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pori, Finland, 28500
- Satakunta Central hospital, department of gynaecology and obstetrics
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 43 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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.
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tablet equal to toremifene, one tablet daily from cycle day 15 to menstruation during three cycles
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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.
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the effects to the MRI findings
Time Frame: after three cycles toremifene and placebo plus wash-out cycle, seven months
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after three cycles toremifene and placebo plus wash-out cycle, seven months
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magnetic resonance imaging changes
Time Frame: seven months
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seven months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
cyclic breast pain relief, quality of life, acceptability of treatment
Time Frame: seven months
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seven months
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breast pain
Time Frame: seven months
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seven months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: JOHANNA MÄENPÄÄ, Tampere University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2007
Primary Completion (Actual)
May 1, 2008
Study Completion (Actual)
February 1, 2009
Study Registration Dates
First Submitted
September 24, 2007
First Submitted That Met QC Criteria
September 24, 2007
First Posted (Estimate)
September 26, 2007
Study Record Updates
Last Update Posted (Estimate)
May 13, 2009
Last Update Submitted That Met QC Criteria
May 12, 2009
Last Verified
May 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Mastodynia
- Physiological Effects of Drugs
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Hormone Antagonists
- Bone Density Conservation Agents
- Selective Estrogen Receptor Modulators
- Estrogen Receptor Modulators
- Toremifene
Other Study ID Numbers
- tore20mg
- EudraCT 2006-006109-97
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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