- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
July 9, 2018 updated by: BioPharmX, Inc.
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
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London, Ontario, Canada, N6A5R8
- KGK Synergize
-
-
-
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Florida
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Orlando, Florida, United States, 32806
- KGK Synergize
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Violet™ Iodine
3mg molecular iodine (I2) daily
|
|
PLACEBO_COMPARATOR: Placebo
3mg placebo daily
|
|
ACTIVE_COMPARATOR: Cross-over
Subjects on placebo will be offered 3 months of active post-treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in self assessed cyclic breast discomfort
Time Frame: After 6 months of active treatment with molecular iodine (I2) compared to placebo
|
After 6 months of active treatment with molecular iodine (I2) compared to placebo
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2016
Primary Completion (ACTUAL)
January 31, 2018
Study Completion (ACTUAL)
January 31, 2018
Study Registration Dates
First Submitted
February 3, 2016
First Submitted That Met QC Criteria
February 5, 2016
First Posted (ESTIMATE)
February 8, 2016
Study Record Updates
Last Update Posted (ACTUAL)
July 10, 2018
Last Update Submitted That Met QC Criteria
July 9, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16VBHB
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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