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
Primary Purpose
Fibrocystic Breast Condition (FBC)
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Violet™ Molecular Iodine (I2)
Placebo
Sponsored by
About this trial
This is an interventional other trial for Fibrocystic Breast Condition (FBC) focused on measuring FBC, cyclic mastalgia, breast discomfort
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- KGK Synergize
- KGK Synergize
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Placebo Comparator
Active Comparator
Arm Label
Violet™ Iodine
Placebo
Cross-over
Arm Description
3mg molecular iodine (I2) daily
3mg placebo daily
Subjects on placebo will be offered 3 months of active post-treatment
Outcomes
Primary Outcome Measures
Change in self assessed cyclic breast discomfort
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02676336
Brief 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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
January 31, 2018 (Actual)
Study Completion Date
January 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioPharmX, Inc.
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibrocystic Breast Condition (FBC)
Keywords
FBC, cyclic mastalgia, breast discomfort
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Violet™ Iodine
Arm Type
Active Comparator
Arm Description
3mg molecular iodine (I2) daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
3mg placebo daily
Arm Title
Cross-over
Arm Type
Active Comparator
Arm Description
Subjects on placebo will be offered 3 months of active post-treatment
Intervention Type
Dietary Supplement
Intervention Name(s)
Violet™ Molecular Iodine (I2)
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in self assessed cyclic breast discomfort
Time Frame
After 6 months of active treatment with molecular iodine (I2) compared to placebo
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Facility Information:
Facility Name
KGK Synergize
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
KGK Synergize
City
London
State/Province
Ontario
ZIP/Postal Code
N6A5R8
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
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
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