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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT 2006-006109-97 |
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| Name | Class |
|---|---|
| Tampere University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A placebo | Placebo Comparator | 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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| B toremifene | Active Comparator | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| toremifene | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| the effects to the MRI findings | after three cycles toremifene and placebo plus wash-out cycle, seven months | |
| magnetic resonance imaging changes | seven months |
| Measure | Description | Time Frame |
|---|---|---|
| cyclic breast pain relief, quality of life, acceptability of treatment | seven months | |
| breast pain | seven months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| SINIKKA OKSA, MD | Satakunta Central Hospital | Principal Investigator |
| JOHANNA MÄENPÄÄ | Tampere University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Satakunta Central hospital, department of gynaecology and obstetrics | Pori | 28500 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16709215 | Background | 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. |
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| ID | Term |
|---|---|
| D059373 | Mastodynia |
| D011293 | Premenstrual Syndrome |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017312 | Toremifene |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013629 | Tamoxifen |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
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| placebo | Drug | tablet equal to toremifene, one tablet daily from cycle day 15 to menstruation during three cycles |
|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |