The Effects of EstroSense®/MD vs Placebo in Improving the Estrogen Profile in Females

NCT02385916 | Completed

• 1 other identifier: H15-00279
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Estrogen Profile

Keywords

EstroSense; estrogen

Outcome Measures

Primary Outcomes (1)

• Changes in urinary 2:16α Ratio

  At baseline, 3 months, 6 months

Study Arms (2)

EstroSense®/MD

EXPERIMENTAL

3 capsules per day during the study period

Other: Placebo

Placebo

PLACEBO COMPARATOR

3 capsules per day during the study period

Other: EstroSense®/MD

Interventions

EstroSense®/MD OTHER

A natural product already approved by Health Canada

Placebo

Placebo OTHER

Placebo

EstroSense®/MD

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• a woman
• years of age
• willing to follow the treatment protocol, study visits and investigations as required by the study.

You may not qualify if:

• are on some certain medications that can interfere with the study such as hormone replacement medications (except birth control), anticoagulants, antiplatelet medications, digoxin, diuretics and breast cancer medications,
• are taking any natural health products that can alter estrogen levels, such as indole-3-carbinol, flaxseed, borage and primrose oil,
• smoke,
• are pregnant or nursing,
• have cancer,
• fibrocystic breast disease,
• family history of ovarian cancer,
• low estrogen or symptoms of low estrogen,
• stomach ulcers or excess stomach acids,
• a known iron deficiency,
• gall stones or bile duct obstruction,
• stomach ulcers or excess stomach acids,
• and or have a history of or known liver disease, kidney disease, thyroid disorders, or adrenal diseases.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, Canada

Location

Related Publications (1)

• Green T, See J, Schauch M, Reil J, Glover M, Brix J, Gerry A, Li K, Newman M, Gahler RJ, Wood S. A randomized, double-blind, placebo-controlled, cross-over trial to evaluate the effect of EstroSense(R) on 2-hydroxyestrone:16alpha-hydroxyestrone ratio in premenopausal women. J Complement Integr Med. 2022 Oct 6;20(1):199-206. doi: 10.1515/jcim-2022-0301. eCollection 2023 Mar 1.

  PMID: 36201753 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 5, 2015
• First Posted: March 11, 2015
• Study Start: April 1, 2015
• Primary Completion: March 1, 2019
• Study Completion: April 1, 2020
• Last Updated: May 10, 2023

Record last verified: 2016-05

Locations

CA (1)