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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
BioPharmX, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Fibrocystic Breast Condition (FBC) focused on measuring FBC, cyclic mastalgia, breast discomfort

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

First Posted
February 3, 2016
Last Updated
July 9, 2018
Sponsor
BioPharmX, Inc.
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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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