Clinical Drug Experience Knowledgebase

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