Hot FlashesphytoSERMNCT01723917
Phytoserms for Menopause Symptoms and Age-Associated Memory Decline
A study testing PhytoSERM tablet in people with Hot Flashes and Memory Loss, run by University of Southern California at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of a soy based dietary supplement (phytoSERM) for hot flashes and age associated memory loss. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women only
- Conditions the study is for
- Hot Flashes, Memory Loss
- What is being tested?
- PhytoSERM tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Jan 2015
- 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 45 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- post-menopausal women
- ages 45 - 60 (inclusive)
- must have a vasomotor symptom (e.g., hot flash) and a memory complaint
Who cannot join
- history of clinically significant stroke
- current evidence or history in past 2 years of epilepsy, seizure, focal brain lesion, head injury with loss of consciousness or any major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse
- Known allergy to soy derived products; hypersensitivity to estrogens or progestins
Trial locations and contacts
1 site in 1 country.
United States1 site
USC Keck School of Medicine
Los Angeles, California, 90033
About this study
Official title: Estrogen Receptor-beta phytoSERMs for Management of Menopause and Age-Associated Memory Decline
The purpose of this study is to evaluate the safety and efficacy of a soy based dietary supplement (phytoSERM) for hot flashes and age associated memory loss.
- Conditions
- Hot Flashes, Memory Loss
- Being tested
- PhytoSERM tablet, placebo
- Medical subject headings
- Hot Flashes, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhytoSERM tabletDietary supplement
placeboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| PhytoSERM 50 mg tablet | Experimental | Dietary supplement: PhytoSERM tablet to be taken once per day for 12 weeks Receives: Dietary Supplement: PhytoSERM tablet |
| PhytoSERM 100 mg tablet | Experimental | Dietary supplement: PhytoSERM tablet to be taken once per day for 12 weeks Receives: Dietary Supplement: PhytoSERM tablet |
| Placebo tablet | Placebo comparator | Dietary supplement: placebo tablet to be taken once per day for 12 weeks Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and tolerability
as measured by assessment of AEs, co-morbid events, laboratory measures, symptoms and cognitive performance
Measured: 12 weeks
efficacy
change from baseline in neuropsychological (cognitive, functional) test results
Measured: 12 weeks
efficacy
change from baseline in vasomotor symptoms
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2012 (estimated)
- Study startJul 2012
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hot FlashesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Lon Schneider, University of Southern California
- Investigators
- Lon S Schneider, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01723917
- Sponsor's protocol ID
- AG033288
- Other IDs
- R01AG033288
- Acronym
- phytoSERM
- Status last verified
- Apr 2019
- First submitted
- 6 Nov 2012
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schneider LS, Hernandez G, Zhao L, Franke AA, Chen YL, Pawluczyk S, Mack WJ, Brinton RD. Safety and feasibility of estrogen receptor-beta targeted phytoSERM formulation for menopausal symptoms: phase 1b/2a randomized clinical trial. Menopause. 2019 Aug;26(8):874-884. doi: 10.1097/GME.0000000000001325.
PubMed 30889096Hernandez G, Zhao L, Franke AA, Chen YL, Mack WJ, Brinton RD, Schneider LS. Pharmacokinetics and safety profile of single-dose administration of an estrogen receptor beta-selective phytoestrogenic (phytoSERM) formulation in perimenopausal and postmenopausal women. Menopause. 2018 Feb;25(2):191-196. doi: 10.1097/GME.0000000000000984.
PubMed 28926513
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estrogen Receptor-beta phytoSERMs for Management of Menopause and Age-Associated Memory Decline
- ClinicalTrials.gov ID
- NCT01723917
- Acronym / sponsor ID
- phytoSERM / AG033288
- Conditions
- Hot Flashes, Memory Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Jul 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 8 Nov 2012 (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.
The purpose of this study is to evaluate the safety and efficacy of a soy based dietary supplement (phytoSERM) for hot flashes and age associated memory loss.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PhytoSERM 50 mg tablet | Experimental | Dietary Supplement: PhytoSERM tabletDietary supplement: PhytoSERM tablet to be taken once per day for 12 weeks |
| PhytoSERM 100 mg tablet | Experimental | Dietary Supplement: PhytoSERM tabletDietary supplement: PhytoSERM tablet to be taken once per day for 12 weeks |
| Placebo tablet | Placebo comparator | Dietary Supplement: placeboDietary supplement: placebo tablet to be taken once per day for 12 weeks |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- post-menopausal women
- ages 45 - 60 (inclusive)
- must have a vasomotor symptom (e.g., hot flash) and a memory complaint
Key exclusion criteria (3 listed)
- history of clinically significant stroke
- current evidence or history in past 2 years of epilepsy, seizure, focal brain lesion, head injury with loss of consciousness or any major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse
- Known allergy to soy derived products; hypersensitivity to estrogens or 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 |
|---|---|---|
| PhytoSERM tablet | Dietary supplement | PhytoSERM 100 mg tablet, PhytoSERM 50 mg tablet |
| placebo | Dietary supplement | Placebo tablet |
Primary outcome
safety and tolerability
Time frame: 12 weeks
as measured by assessment of AEs, co-morbid events, laboratory measures, symptoms and cognitive performance
efficacy
Time frame: 12 weeks
change from baseline in neuropsychological (cognitive, functional) test results
efficacy
Time frame: 12 weeks
change from baseline in vasomotor symptoms
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 4 Apr 2019.
- Derived from this study: PubMed 30889096Schneider LS, Hernandez G, Zhao L, Franke AA, Chen YL, Pawluczyk S, Mack WJ, Brinton RD. Safety and feasibility of estrogen receptor-beta targeted phytoSERM formulation for menopausal symptoms: phase 1b/2a randomized clinical trial. Menopause. 2019 Aug;26(8):874-884. doi: 10.1097/GME.0000000000001325.
- Derived from this study: PubMed 28926513Hernandez G, Zhao L, Franke AA, Chen YL, Mack WJ, Brinton RD, Schneider LS. Pharmacokinetics and safety profile of single-dose administration of an estrogen receptor beta-selective phytoestrogenic (phytoSERM) formulation in perimenopausal and postmenopausal women. Menopause. 2018 Feb;25(2):191-196. doi: 10.1097/GME.0000000000000984.
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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.
Lon S Schneider, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PhytoSERM tablet in people with Hot Flashes and Memory Loss, run by University of Southern California 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 3 inclusion and 3 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 4 Apr 2019. 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. 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?
safety and tolerability (time frame: 12 weeks). The study lists 3 primary outcomes in all. 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 NCT01723917, which also lists 2 linked publications.
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 4 Apr 2019.