Breast PainPhase 3NCT00534846
The Effect of Toremifene Treatment to the Magnetic Resonance Imaging (MRI) Findings in Premenstrual Mastalgia
A Phase 3 study testing toremifene in people with Breast Pain, run by Satakunta Central Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Pain
- What is being tested?
- toremifene
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteFinland
- Study dates
- Apr 2007to Feb 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Premenstrual mastalgia
- Age 20-45 years
- Reliable non-hormonal contraception
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Finland1 site
Satakunta Central hospital, department of gynaecology and obstetrics
Pori, 28500
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Pain
- Being tested
- toremifene, placebo
- Keywords
- premenstrual syndrome, mastalgia, toremifene, selective estrogen receptor modulators
- Medical subject headings
- Mastodynia, Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
toremifeneDrug
Also called magnetic resonance imaging, cyclic breast pain
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.
placeboDrug
tablet equal to toremifene, one tablet daily from cycle day 15 to menstruation during three cycles
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: placebo |
| 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. Receives: Drug: toremifene |
What is being measured
The primary outcome is the main question the study is designed to answer.
the effects to the MRI findings
Measured: after three cycles toremifene and placebo plus wash-out cycle, seven months
magnetic resonance imaging changes
Measured: seven months
Secondary outcomes (2)
cyclic breast pain relief, quality of life, acceptability of treatment
Measured: seven months
breast pain
Measured: seven months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startApr 2007
- Primary completionMay 2008
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Satakunta Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University
- Investigators
- SINIKKA OKSA, MD, Principal investigator, Satakunta Central HospitalJOHANNA MÄENPÄÄ, Study director, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00534846
- Sponsor's protocol ID
- tore20mg
- Other IDs
- EudraCT 2006-006109-97
- Status last verified
- May 2009
- First submitted
- 24 Sep 2007
- Last updated
- 13 May 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16709215
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Toremifene Treatment to the Magnetic Resonance Imaging Findings in Women Suffering From Premenstrual Mastalgia
- ClinicalTrials.gov ID
- NCT00534846
- Acronym / sponsor ID
- tore20mg
- Conditions
- Breast Pain
- Keywords
- premenstrual syndrome, mastalgia, toremifene, selective estrogen receptor modulators
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Satakunta Central HospitalUniversity, hospital or other
- Collaborators
- Tampere University
- Study start
- Apr 2007
- Primary completion
- May 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 26 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A placebo | Placebo comparator | Drug: placeboThe participants were randomly allocated to receive toremifene (20 mg) or placebo during the luteal phase for three consecutive menstrual cycles. |
| B toremifene | Active comparator | Drug: toremifeneThe participants were randomly allocated to receive toremifene (20 mg) or placebo during the luteal phase for three consecutive menstrual cycles. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Premenstrual mastalgia
- Age 20-45 years
- Reliable non-hormonal contraception
Key exclusion criteria (8 listed)
- Pregnancy
- Breast cancer or uterine corpus cancer
- Unexplained menstrual disorders
- Serious health problems
- Hormonal contraception, including hormonal IUD trade name Mirena
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| toremifeneAlso: magnetic resonance imaging, cyclic breast painThe 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. | Drug | B toremifene |
| placebotablet equal to toremifene, one tablet daily from cycle day 15 to menstruation during three cycles | Drug | A placebo |
Primary outcome
the effects to the MRI findings
Time frame: after three cycles toremifene and placebo plus wash-out cycle, seven months
magnetic resonance imaging changes
Time frame: seven months
2 secondary outcomes
cyclic breast pain relief, quality of life, acceptability of treatment
Time frame: seven months
breast pain
Time frame: seven months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2009.
- Background: PubMed 16709215Oksa 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SINIKKA OKSA, MD principal investigator
Satakunta Central Hospital
JOHANNA MÄENPÄÄ study director
Tampere University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing toremifene in people with Breast Pain, run by Satakunta Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the effects to the MRI findings (time frame: after three cycles toremifene and placebo plus wash-out cycle, seven months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00534846, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2009.