Estrogen ProfileNCT02385916
The Effects of EstroSense®/MD vs Placebo in Improving the Estrogen Profile in Females
A study testing EstroSense®/MD in people with Estrogen Profile, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Estrogen Profile
- What is being tested?
- EstroSense®/MD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2015to Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- a woman
- 20-50 years of age
- willing to follow the treatment protocol, study visits and investigations as required by the study.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Estrogen Profile
- Being tested
- EstroSense®/MD, Placebo
- Keywords
- EstroSense, estrogen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EstroSense®/MDOther
A natural product already approved by Health Canada
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| EstroSense®/MD | Experimental | 3 capsules per day during the study period Receives: Other: Placebo |
| Placebo | Placebo comparator | 3 capsules per day during the study period Receives: Other: EstroSense®/MD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in urinary 2:16α Ratio
Measured: At baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionMar 2019
- Study completionApr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Estrogen ProfileStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tim Green, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02385916
- Sponsor's protocol ID
- H15-00279
- Status last verified
- May 2016
- First submitted
- 5 Mar 2015
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 36201753
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02385916
- Acronym / sponsor ID
- H15-00279
- Conditions
- Estrogen Profile
- Keywords
- EstroSense, estrogen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 11 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EstroSense®/MD | Experimental | Other: Placebo3 capsules per day during the study period |
| Placebo | Placebo comparator | Other: EstroSense®/MD3 capsules per day during the study period |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- a woman
- 20-50 years of age
- willing to follow the treatment protocol, study visits and investigations as required by the study.
Key exclusion criteria (13 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EstroSense®/MDA natural product already approved by Health Canada | Other | Placebo |
| PlaceboPlacebo | Other | EstroSense®/MD |
Primary outcome
Changes in urinary 2:16α Ratio
Time frame: At baseline, 3 months, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Derived from this study: PubMed 36201753Green 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.
Related trials for Estrogen Profile
Active, not recruiting
Effects of Estrogen Therapy on Lipid Metabolism and Insulin Sensitivity in Hypogonadal Women
Female Hypogonadism
RecruitingObservational study
To Establish Whether Individuals With Premenstrual Dysphoric Disorder (PMDD) Demonstrate a Different Luteal-phase Sex Hormone Profile and Ratio Compared With Asymptomatic Controls.
Premenstrual Dysphoric Disorder ( PMDD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EstroSense®/MD in people with Estrogen Profile, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in urinary 2:16α Ratio (time frame: At baseline, 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02385916, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.