Circulatory; ChangePhase 3NCT01417754
Changes in Breast 3D Ultrasound Measurements Using Toremifene
A Phase 3 study testing Toremifene in people with Circulatory; Change, run by Satakunta Central Hospital at 1 site in Finland.
Trial summary
To investigate if there are detectable changes in volume and circulation in breasts of healthy volunteers using toremifene 20 mg in luteal phase of the menstruation cycle versus nonmedicated cycle. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Circulatory; Change
- What is being tested?
- Toremifene
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2010to Jun 2011
- 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 25 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 25-45 healthy person
- regular menstrual cycles
- safe contraception(for example sterilization or condom)
Who cannot join
- gynecological or other type of cancer
- hormonal contraception
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Volume and Circulation Changes of The Breast in 3D Ultrasound During Toremifene Versus Nonmedicated Menstrual Cycle
To investigate if there are detectable changes in volume and circulation in breasts of healthy volunteers using toremifene 20 mg in luteal phase of the menstruation cycle versus nonmedicated cycle.
Read the detailed description
20 women were participated to this trial.
- Conditions
- Circulatory; Change
- Being tested
- Toremifene
- Keywords
- toremifene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToremifeneDrug
Also called trade name Fareston
20mg toremifene per day in tablet form starting from the cycle day 15 and continued to premenstrual period. Medication using about 10 days per volunteer
| Study group | Role | What they receive |
|---|---|---|
| Toremifene | Other | Not described Receives: Drug: Toremifene |
What is being measured
The primary outcome is the main question the study is designed to answer.
circulation changes of the breast
Measured: cycle day 23 to 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2011 (estimated)
- Study startSep 2010
- Primary completionNov 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circulatory; ChangeStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Satakunta Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University Hospital, Tampere University
- Responsible party
- Principal investigator, SINIKKA OKSA, Satakunta Central Hospital
- Investigators
- Sinikka Oksa, MD, Principal investigator, Satakunta Central HospitalJohanna Mäenpää, professor, Study director, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01417754
- Sponsor's protocol ID
- Tore3D
- Status last verified
- Aug 2011
- First submitted
- 28 Jul 2011
- Last updated
- 23 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volume and Circulation Changes of The Breast in 3D Ultrasound During Toremifene Versus Nonmedicated Menstrual Cycle
- ClinicalTrials.gov ID
- NCT01417754
- Acronym / sponsor ID
- Tore3D
- Conditions
- Circulatory; Change
- Keywords
- toremifene
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Satakunta Central HospitalUniversity, hospital or other
- Collaborators
- Tampere University Hospital, Tampere University
- Study start
- Sep 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 16 Aug 2011 (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.
To investigate if there are detectable changes in volume and circulation in breasts of healthy volunteers using toremifene 20 mg in luteal phase of the menstruation cycle versus nonmedicated cycle.
Detailed description
20 women were participated to this trial.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Toremifene | Other | Drug: Toremifene |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age 25-45 healthy person
- regular menstrual cycles
- safe contraception(for example sterilization or condom)
Key exclusion criteria (3 listed)
- gynecological or other type of cancer
- hormonal contraception
- pregnancy
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: trade name Fareston20mg toremifene per day in tablet form starting from the cycle day 15 and continued to premenstrual period. Medication using about 10 days per volunteer | Drug | Toremifene |
Primary outcome
circulation changes of the breast
Time frame: cycle day 23 to 26
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 23 Aug 2011.
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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, professor 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 Circulatory; Change, 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 3 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 23 Aug 2011. 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. 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?
circulation changes of the breast (time frame: cycle day 23 to 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Aug 2011.