Fibrocystic Breast Condition (FBC)NCT02676336
A Randomized Double-blind, Placebo Controlled, Multi-center Study to Evaluate the Safety, Tolerability and Potential Effects of the Dietary Supplement Violet™ Molecular Iodine (I2) on Breast Health in Women With Cyclic Breast Discomfort and Tenderness
A study testing Violet™ Molecular Iodine (I2) in people with Fibrocystic Breast Condition (FBC), run by BioPharmX, Inc. at 2 sites in 2 countries.
Trial summary
This is a randomized, double-blind, placebo controlled, multi-center study to evaluate the safety, tolerability and potential effects of dietary supplement Violet™ Iodine on breast health in women with cyclic breast discomfort and tenderness to eliminate the evaluation of effectiveness. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fibrocystic Breast Condition (FBC)
- What is being tested?
- Violet™ Molecular Iodine (I2)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Feb 2016to 31 Jan 2018
- Phase
- Interventional
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy premenopausal females ≥ 18 years of age
- BMI 20.0 - 29.9 kg/m2 (± 1 kg/m2)
- Females of childbearing potential must agree to use a reliable and consistent method of birth control in the Investigator's opinion, excluding depot contraceptives and Explanon, and have a negative urine pregnancy test result. Hormonal contraceptives such as oral contraceptives, birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing) are all acceptable as long as the subject is on a stable dose and agrees not to change during the study period
- No apparent health conditions that in the investigator's opinion would interfere with study participation, compliance or interpretation of endpoints or would not be in the best interest of the subject
- Moderate to severe cyclic breast discomfort of at least 4 days per month (discomfort ≥4 on a 0-10 scale)
- No known medical or psychological condition that in the investigator's opinion could interfere with study participation
- Agrees to comply with all study related procedures and visits including access to a smartphone (Android or iOS) and ability to enter daily diary information via a smart phone app
- Capable of reading and understanding study related materials (in English or French) and has given voluntary, written, informed consent to participate in the study
Who cannot join
- Women who are pregnant, breast feeding, or planning to become pregnant during the course of the trial
- Perimenopausal or irregular menstrual cycles
- Women who have had an oophorectomy
- Known thyroid condition or currently taking any thyroid medications
- Prior bariatric surgery or other interventions or medications that might affect gastric pH
- Use of iodine supplementation, Tamoxifen, Lupron, or Danazol, in the last 6 months
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- Clinically significant abnormal laboratory results at Screening
- Breast implant surgeries that have not fully healed or have ongoing problems associated with the implant (i.e. seroma, infection etc.)
- Planned elective surgeries to occur during participation in the study
- Known allergy or sensitivity to study product ingredients (e.g. Iodine)
- History of alcohol or drug abuse within the past year
- Use of medicinal marijuana within the past year
- Participation in a clinical research trial within 30 days prior to randomization or plans to participate in any other study during the next 11 months
- Individuals who are cognitively impaired and/or who are unable to give informed consent
- Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures, may confound interpretation of study outcome measures (such as another condition) or which may pose significant risk to the subject
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
This is a randomized, double-blind, placebo controlled, multi-center study to evaluate the safety, tolerability and potential effects of dietary supplement Violet™ Iodine on breast health in women with cyclic breast discomfort and tenderness to eliminate the evaluation of effectiveness.
- Conditions
- Fibrocystic Breast Condition (FBC)
- Being tested
- Violet™ Molecular Iodine (I2), Placebo
- Keywords
- FBC, cyclic mastalgia, breast discomfort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Violet™ Molecular Iodine (I2)Dietary supplement
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Violet™ Iodine | Active comparator | 3mg molecular iodine (I2) daily Receives: Dietary Supplement: Violet™ Molecular Iodine (I2) |
| Placebo | Placebo comparator | 3mg placebo daily Receives: Other: Placebo |
| Cross-over | Active comparator | Subjects on placebo will be offered 3 months of active post-treatment Receives: Dietary Supplement: Violet™ Molecular Iodine (I2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self assessed cyclic breast discomfort
Measured: After 6 months of active treatment with molecular iodine (I2) compared to placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completion31 Jan 2018
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibrocystic Breast Condition (FBC)Studies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioPharmX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676336
- Sponsor's protocol ID
- 16VBHB
- Status last verified
- Jul 2018
- First submitted
- 3 Feb 2016
- Last updated
- 10 Jul 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blind, Placebo Controlled, Multi-center Study to Evaluate the Safety, Tolerability and Potential Effects of the Dietary Supplement Violet™ Molecular Iodine (I2) on Breast Health in Women With Cyclic Breast Discomfort and Tenderness
- ClinicalTrials.gov ID
- NCT02676336
- Acronym / sponsor ID
- 16VBHB
- Conditions
- Fibrocystic Breast Condition (FBC)
- Keywords
- FBC, cyclic mastalgia, breast discomfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- BioPharmX, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 8 Feb 2016 (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.
This is a randomized, double-blind, placebo controlled, multi-center study to evaluate the safety, tolerability and potential effects of dietary supplement Violet™ Iodine on breast health in women with cyclic breast discomfort and tenderness to eliminate the evaluation of effectiveness.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Violet™ Iodine | Active comparator | Dietary Supplement: Violet™ Molecular Iodine (I2)3mg molecular iodine (I2) daily |
| Placebo | Placebo comparator | Other: Placebo3mg placebo daily |
| Cross-over | Active comparator | Dietary Supplement: Violet™ Molecular Iodine (I2)Subjects on placebo will be offered 3 months of active post-treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy premenopausal females ≥ 18 years of age
- BMI 20.0 - 29.9 kg/m2 (± 1 kg/m2)
- Females of childbearing potential must agree to use a reliable and consistent method of birth control in the Investigator's opinion, excluding depot contraceptives and Explanon, and have a negative urine pregnancy test result. Hormonal contraceptives such as oral contraceptives, birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing) are all acceptable as long as the subject is on a stable dose and agrees not to change during the study period
- No apparent health conditions that in the investigator's opinion would interfere with study participation, compliance or interpretation of endpoints or would not be in the best interest of the subject
- Moderate to severe cyclic breast discomfort of at least 4 days per month (discomfort ≥4 on a 0-10 scale)
Key exclusion criteria (15 listed)
- Women who are pregnant, breast feeding, or planning to become pregnant during the course of the trial
- Perimenopausal or irregular menstrual cycles
- Women who have had an oophorectomy
- Known thyroid condition or currently taking any thyroid medications
- Prior bariatric surgery or other interventions or medications that might affect gastric pH
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 |
|---|---|---|
| Violet™ Molecular Iodine (I2) | Dietary supplement | Cross-over, Violet™ Iodine |
| Placebo | Other | Placebo |
Primary outcome
Change in self assessed cyclic breast discomfort
Time frame: After 6 months of active treatment with molecular iodine (I2) compared to placebo
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 10 Jul 2018.
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Violet™ Molecular Iodine (I2) in people with Fibrocystic Breast Condition (FBC), run by BioPharmX, Inc. at 2 sites in 2 countries.
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 8 inclusion and 15 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 10 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. 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.
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?
Change in self assessed cyclic breast discomfort (time frame: After 6 months of active treatment with molecular iodine (I2) compared to placebo). 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 10 Jul 2018.