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

BioPharmX, Inc.1 site in 1 country31 target enrollmentFebruary 2016

ConditionsFibrocystic Breast Condition (FBC)

Overview

Phase: N/A
Intervention: Not specified
Conditions: Fibrocystic Breast Condition (FBC)
Sponsor: BioPharmX, Inc.
Enrollment: 31
Locations: 1
Primary Endpoint: Change in self assessed cyclic breast discomfort
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2016

End Date

January 31, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

BioPharmX, Inc.

Responsible Party

Sponsor

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)