The Effects of EstroSense®/MD vs Placebo in Improving the Estrogen Profile in Females
Condition: Estrogen Profile
Study type: Interventional

Summary: 
      According to the Canadian Cancer Society, 1 in 9 Canadian women will develop breast cancer in
      her lifetime and 1 in 30 will die. The single greatest risk factor of breast cancer is poor
      estrogen metabolism. EstroSense®/MD is a natural health product that promotes and supports
      healthy estrogen metabolism. It may increase the ratio of "good estrogen" to "bad estrogen"
      and potentially reducing the risk of breast cancer. For this proposed study, the
      investigators will be examining the effect of EstroSense®/MD compared to placebo, on estrogen
      metabolism in 120 women.
    

Detailed description: 
      This randomised, double blind, placebo controlled, crossover trial will evaluate the effects
      of daily consumption of EstroSense®/MD on estrogen profile in female subjects. 120 consenting
      women will be enrolled (randomised) to participate in this study. Potential subjects will be
      recruited by advertisements placed on notice boards around the university and at local
      naturopath clinics. Advertisements may also be placed in local newspapers. The study consists
      of four clinic visits. Individuals who are interested in participating will be asked to
      contact the study coordinator to schedule their first clinic visit (Visit 1). At Visit 1 the
      participant will be given information about the study and be given an opportunity to ask
      about the study. Those women who are still interested in participating will be asked to sign
      a consent form. Once consent if obtained screening and baseline data collection will begin.
      If eligible, participants will be scheduled to return to the clinic 19-21 days after the
      beginning of their last or next menstruation for Visit 2. At Visit 2 baseline data collection
      will continue followed by random assignment to an intervention sequence. All participants
      will be given and instructed to consume 3 capsules per day of EstroSense®/MD or Placebo for
      three menstrual cycles. After consuming the study intervention for 3 cycles, the participant
      will be asked to return to the clinic (19-21 days after the start of their third
      menstruation) for Visit 3. At Visit 3 data will be collected and participants will be crossed
      over to the other treatment for three more cycles. After 3 menstrual cycles (19-21 days after
      the start of their third menstruation) the participant will return to the clinic for Visit 4
      for final data collection. Visit 4 marks the end of the study. Participants will also be
      provided with a diary throughout the study to record supplement use and any adverse events.
    

Intervention name(s): EstroSense®/MD; Placebo
Intervention type(s): Other; Other
Intervention description(s): A natural product already approved by Health Canada; Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: EstroSense; estrogen