MenopauseEFE1NCT05959057
ERr 731® Formulation Evaluation
A study testing ERr 731 - Micro-coated and ERr 731 - Enteric coated in people with Menopause, run by Metagenics, Inc. at 1 site in United States.
Trial summary
A comparison of an enteric coated and micro-coated formulation of ERr 731® Read more about this study
- Who is it for?
- Ages 35 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- ERr 731 - Micro-coated and ERr 731 - Enteric coated
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2023to 18 Aug 2023
- 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 35 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages 35-64, inclusive, preference given to Subjects Ages 45-54, inclusive
- Preference given to symptomatic Subjects; symptoms including vasomotor symptoms, mood disturbances, fatigue, myalgias and arthralgias.
Who cannot join
- A serious, unstable illness including cardiac, hepatic, renal, gastrointestinal, respiratory, endocrinologic, neurologic, immunologic/rheumatological, or oncological/hematologic disease.
- History of Breast or Uterine cancers.
- Known infection with HIV, Tuberculosis or Hepatitis B or C.
- Hormone Replacement Therapy: All formulations of synthetic estrogens, natural estrogens (estrone, estradiol and estriol) and progestins (including natural progesterone)
- Hormonal Contraceptives: All formulations of synthetic estrogens and progestins
- Botanical Formulations - including phytoestrogens and progesterone-mimetic botanicals (Rhapontic Rhubarb, Soy Phytoestrogens, Hops (8-prenyl naringin) Red Clover, Kudzu, Chaste Tree Berry, Licorice, Resveratrol, Black Cohosh, Dong Quai, etc.)
Show all 13Show fewer
- Use of Narcotics during the last 30 days
- Use of Anticoagulants during last 30 days
- Use of Corticosteroids during the last 30 days
- Use of controlled substances (other than marijuana or CBD) on a recreational basis during the last 30 days.
- Consumption of more than 3 alcoholic beverages per day (One beverage is a 5-ounce glass of wine, 12 ounces of beer, or one ounce of hard liquor)
- Pregnancy
- Breast Feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Personalized Lifestyle Medicine Center
Gig Harbor, Washington, 98332
About this study
Official title: ERr 731® Formulation Evaluation: A Comparison of Enteric Coated and Micro-coated ERr 731® Formulations
A comparison of an enteric coated and micro-coated formulation of ERr 731®
Read the detailed description
Current clinical and commercialization experiences have been with enteric-coated formulations of ERr 731®. With the demonstrated safety of this formulation and the absence of anthraquinones in the extract, there is interest in launching a micro-coated, but not enteric-coated, formulation to broaden the commercial availability of ERr 731® in new markets. It is proposed that a double-blinded, randomized cross-over design in a peri-menopausal/menopausal and preferably symptomatic group of women (target population for commercialization) is best suited to demonstrate equivalent tolerability.
- Conditions
- Menopause
- Being tested
- ERr 731 - Micro-coated, ERr 731 - Enteric coated
- Keywords
- Botanical supplement, Formulation, Rhapontic Rhubarb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERr 731 - Micro-coatedDietary supplement
natural extract of the Rheum Rhaponticum L plant (Siberian rhubarb). The primary active constituents of ERr 731® are hydroxystilbenes, primarily rhaponticin and desoxyrhaponticin.
ERr 731 - Enteric coatedDietary supplement
Also called Estrovera
natural extract of the Rheum Rhaponticum L plant (Siberian rhubarb). The primary active constituents of ERr 731® are hydroxystilbenes, primarily rhaponticin and desoxyrhaponticin.
| Study group | Role | What they receive |
|---|---|---|
| Enteric/Micro Order | Experimental | Subjects will receive randomly two distinct formulations of ERr 731® in a 43 day trial consisting of treatment phase 1 (14-days), washout phase (14-days),treatment phase 2 (14-days): Arm 1 will receive enteric coated ERr 731® during treatment phase 1 and micro-coated ERr 731®during treatment phase 2 Receives: Dietary Supplement: ERr 731 - Micro-coated; Dietary Supplement: ERr 731 - Enteric coated |
| Micro/Enteric Order | Experimental | Subjects will receive randomly two distinct formulations of ERr 731® in a 43 day trial consisting of treatment phase 1 (14-days), washout phase (14-days),treatment phase 2 (14-days): Arm 2 will receive micro-coated ERr 731® during treatment phase 1 and enteric coated ERr 731®during treatment phase 2 Receives: Dietary Supplement: ERr 731 - Micro-coated; Dietary Supplement: ERr 731 - Enteric coated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal Tolerability
Frequency of symptoms of gastrointestinal nature collected on a custom questionnaire
Measured: 14 days
Secondary outcomes (1)
General Tolerability
Frequency of general symptoms collected on a custom questionnaire
Measured: 14 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start24 May 2023
- Primary completion18 Aug 2023
- Study completion18 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- double-blinded, randomized cross-over design in a peri-menopausal/menopausal and preferably symptomatic group of women (target population for commercialization) is best suited to demonstrate equivalent tolerability
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Metagenics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05959057
- Sponsor's protocol ID
- 2023-002
- Acronym
- EFE1
- Status last verified
- Oct 2023
- First submitted
- 24 Apr 2023
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ERr 731® Formulation Evaluation: A Comparison of Enteric Coated and Micro-coated ERr 731® Formulations
- ClinicalTrials.gov ID
- NCT05959057
- Acronym / sponsor ID
- EFE1 / 2023-002
- Conditions
- Menopause
- Keywords
- Botanical supplement, Formulation, Rhapontic Rhubarb
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Metagenics, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 May 2023 (actual)
- Primary completion
- 18 Aug 2023 (actual)
- Study completion
- 18 Aug 2023 (actual)
- First posted
- 25 Jul 2023 (actual)
- 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.
A comparison of an enteric coated and micro-coated formulation of ERr 731®
Detailed description
Current clinical and commercialization experiences have been with enteric-coated formulations of ERr 731®. With the demonstrated safety of this formulation and the absence of anthraquinones in the extract, there is interest in launching a micro-coated, but not enteric-coated, formulation to broaden the commercial availability of ERr 731® in new markets. It is proposed that a double-blinded, randomized cross-over design in a peri-menopausal/menopausal and preferably symptomatic group of women (target population for commercialization) is best suited to demonstrate equivalent tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- double-blinded, randomized cross-over design in a peri-menopausal/menopausal and preferably symptomatic group of women (target population for commercialization) is best suited to demonstrate equivalent tolerability
| Arm | Type | Receives |
|---|---|---|
| Enteric/Micro Order | Experimental | Dietary Supplement: ERr 731 - Micro-coated, Dietary Supplement: ERr 731 - Enteric coatedSubjects will receive randomly two distinct formulations of ERr 731® in a 43 day trial consisting of treatment phase 1 (14-days), washout phase (14-days),treatment phase 2 (14-days): Arm 1 will receive enteric coated ERr 731® during treatment phase 1 and micro-coated ERr 731®during treatment phase 2 |
| Micro/Enteric Order | Experimental | Dietary Supplement: ERr 731 - Micro-coated, Dietary Supplement: ERr 731 - Enteric coatedSubjects will receive randomly two distinct formulations of ERr 731® in a 43 day trial consisting of treatment phase 1 (14-days), washout phase (14-days),treatment phase 2 (14-days): Arm 2 will receive micro-coated ERr 731® during treatment phase 1 and enteric coated ERr 731®during treatment phase 2 |
Who may qualify
- Ages
- 35 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Ages 35-64, inclusive, preference given to Subjects Ages 45-54, inclusive
- Preference given to symptomatic Subjects; symptoms including vasomotor symptoms, mood disturbances, fatigue, myalgias and arthralgias.
Key exclusion criteria (13 listed)
- A serious, unstable illness including cardiac, hepatic, renal, gastrointestinal, respiratory, endocrinologic, neurologic, immunologic/rheumatological, or oncological/hematologic disease.
- History of Breast or Uterine cancers.
- Known infection with HIV, Tuberculosis or Hepatitis B or C.
- Hormone Replacement Therapy: All formulations of synthetic estrogens, natural estrogens (estrone, estradiol and estriol) and progestins (including natural progesterone)
- Hormonal Contraceptives: All formulations of synthetic estrogens and progestins
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 |
|---|---|---|
| ERr 731 - Micro-coatednatural extract of the Rheum Rhaponticum L plant (Siberian rhubarb). The primary active constituents of ERr 731® are hydroxystilbenes, primarily rhaponticin and desoxyrhaponticin. | Dietary supplement | Enteric/Micro Order, Micro/Enteric Order |
| ERr 731 - Enteric coatedAlso: Estroveranatural extract of the Rheum Rhaponticum L plant (Siberian rhubarb). The primary active constituents of ERr 731® are hydroxystilbenes, primarily rhaponticin and desoxyrhaponticin. | Dietary supplement | Enteric/Micro Order, Micro/Enteric Order |
Primary outcome
Gastrointestinal Tolerability
Time frame: 14 days
Frequency of symptoms of gastrointestinal nature collected on a custom questionnaire
1 secondary outcome
General Tolerability
Time frame: 14 Days
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 30 Oct 2023.
- Individual participant dataSharing planned: No
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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 ERr 731 - Micro-coated and ERr 731 - Enteric coated in people with Menopause, run by Metagenics, Inc. at 1 site in United States.
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 2 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 30 Oct 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 United States. 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. 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?
Gastrointestinal Tolerability (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2023.