- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02385916
The Effects of EstroSense®/MD vs Placebo in Improving the Estrogen Profile in Females
May 8, 2023 updated by: Tim Green, University of British Columbia
A Randomised, Double Blind, Placebo Controlled, Cross-over Trial Evaluating the Effects of EstroSense®/MD (PNO) vs Placebo in Increasing 2:16α Ratio and Improving the Estrogen Profile in Females
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Wangyang Li, MSc.
- Phone Number: 6046191326
- Email: wylee85@hotmail.com
Study Contact Backup
- Name: Tim Green, PhD
- Phone Number: 6048220421
- Email: tigreen@mail.ubc.ca
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada
- University of British Columbia
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- a woman
- 20-50 years of age
- willing to follow the treatment protocol, study visits and investigations as required by the study.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: EstroSense®/MD
3 capsules per day during the study period
|
Placebo
|
Placebo Comparator: Placebo
3 capsules per day during the study period
|
A natural product already approved by Health Canada
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in urinary 2:16α Ratio
Time Frame: At baseline, 3 months, 6 months
|
At baseline, 3 months, 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2015
Primary Completion (Actual)
March 1, 2019
Study Completion (Actual)
April 1, 2020
Study Registration Dates
First Submitted
March 5, 2015
First Submitted That Met QC Criteria
March 10, 2015
First Posted (Estimate)
March 11, 2015
Study Record Updates
Last Update Posted (Actual)
May 10, 2023
Last Update Submitted That Met QC Criteria
May 8, 2023
Last Verified
May 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- H15-00279
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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