MenopauseNCT04516304
A Nutritional Supplement on Vasomotor Symptoms in Women
A study testing S-equol in people with Menopause, run by Pharmavite LLC at 1 site in United States.
Trial summary
Vasomotor symptoms (VMS), such as flushes, sweating, and sleep disturbances, are experienced by up to 80% of women during the menopausal transition. Night sweats, which are hot flushes that occur at night, can be particularly bothersome in women and contribute to disturbed sleep. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- S-equol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2019to 22 May 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 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is a perimenopausal or menopausal female experiencing specific menopausal-related VMS.
- Subject has a BMI of ≥18.5 to ≤38.0 kg/m2 at Visit 1 (week -3).
- At screening visit (Visit 1; week -3), subject reports to have 4 or more moderate to severe hot flushes/night sweats during 24 h prior to the visit. At Visit 3 (week -1), subject has ≥25 moderate to severe hot flushes/night sweats per week for one week between Visit 2 and 3 (weeks -2 and -1). At Visit 4 (week 0), subject has an average ≥28 moderate to severe hot flushes/night sweats per week for 2 weeks before Visit 4 (week 0).
- Subject is willing to maintain habitual diet (with the exception of restricted foods/beverages), physical activity patterns, and body weight during the study period.
- Subject is willing to abstain from using products (other than study product) that contains estrogen, progestin, or progesterone within 30 d prior to Visit 1 (week -3) and throughout the study trial.
- If a smoker, subject is willing to maintain current smoking habits.
- Subject has no health conditions that would prevent her from fulfilling the study requirements as judged by the Clinical Investigator on the basis of medical history and routine laboratory test results.
- Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Clinical Investigator.
Who cannot join
- Subject has abnormal laboratory test results of clinical importance at Visit 1 (week -3) at the discretion of the Investigator.
- Subject has a history or presence of clinically important pulmonary (including uncontrolled asthma), cardiac (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), hepatic, renal, endocrine, hematologic, immunologic (including chronic inflammatory conditions), neurologic (such as Alzheimer's or Parkinson's disease), psychiatric (including depression and/or anxiety disorders) or biliary disorders, that, in the opinion of the Clinical Investigator, could interfere with the interpretation of the study results.
- Subject has a history or presence of any gastrointestinal condition that could potentially interfere with absorption of the study product (e.g., inflammatory bowel syndrome, celiac disease, history of gastric bypass surgery).
- Subject has a history of estrogen-dependent neoplasia, atypical ductual hyperplasia of the breast, or undiagnosed vaginal bleeding.
- Subject has a history of endometrial hyperplasia, melanoma, or uterine/endometrial breast or ovarian cancer.
- Subject has uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg) as defined by the blood pressure measured at Visit 1 (week -3). One re-test will be allowed on a separate day for subjects whose blood pressure exceeds either of these cut points at Visit 1, in the judgment of the Clinical Investigator.
Show all 16Show fewer
- Subject has a history of any major trauma or major surgical event within two months of Visit 1 (week -3).
- Subject has a history or presence of cancer in the prior 2 years to Visit 1 (week -3), except for non-melanoma skin cancer.
- Subject has a contraindication to estrogen and/or progestin therapy or allergy/sensitivity to the use of estradiol and/or progesterone, soy, or any components in the study product.
- Subject has used estrogen alone or estrogen/progestin, selective estrogen receptor modulator, testosterone, or estrogen/testosterone within 30 d prior to Visit 1 (week -3).
- Subject has used any prescription or over-the-counter products/supplements (e.g., soy products, herbal supplements) that have potential to alter progesterone or estrogen activity or is being used to treat VMS within 30 d prior to Visit 1 (week -3).
- Subject has self-described extreme or irregular dietary habits, in the opinion of the Clinical Investigator or has been diagnosed with an eating disorder.
- Subject has elective hospitalizations planned (e.g., elective cosmetic procedures) during the study period.
- Subject has been exposed to any non-registered drug product or has participated in another intervention study within 30 d prior to Visit 1 (week -3).
- Subject has a recent history of (within 12 months of screening; Visit 1; week -3) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
- Individual has a condition the Clinical Investigator believes would interfere with his ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the subject at undue risk.
Trial locations and contacts
1 site in 1 country.
United States1 site
Biofortis Clinical Research
Addison, Illinois, 60601
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled Study to Assess a Nutritional Supplement on Vasomotor Symptoms In Perimenopausal and Menopausal Women
Vasomotor symptoms (VMS), such as flushes, sweating, and sleep disturbances, are experienced by up to 80% of women during the menopausal transition. Night sweats, which are hot flushes that occur at night, can be particularly bothersome in women and contribute to disturbed sleep. These symptoms occur mainly during the 1-3 years prior to menopause (late perimenopause) and early menopause (~4 years after menstruation ceases). Many women look to supplements for the management of menopausal symptoms. Soy isoflavones and their metabolites are one category of dietary supplements that have been extensively studied for the management of VMS. The most active soy isoflavone is S-equol, which is not found directly in soy, but rather is the metabolite that is produced by gut microflora from consumption of the soy isoflavone daidzein. However, only 20-30% of US women are actually able to produce S-equol from the consumption of daidzein. Equelle® is a currently available dietary supplement that has S-equol as its active component, which allows the delivery of the active soy isoflavone metabolite directly without dependence on the gut microflora metabolism. The intention of this study is to assess the effect of a product containing S-equol on the management of VMS in normally healthy women.
Condition or disease: Vasomotor Symptoms
Read more
Intervention/treatment:
Dietary Supplement: S-equol Dietary Supplement: Placebo
Read the detailed description
This is a randomized, placebo-controlled, double-blind, parallel study, which will include a screening visit (Visit 1; week -3), a 2-week run-in period for baseline determination and assessment of placebo response (Visit 2; week -2; and Visit 3; week -1), one baseline visit (Visit 4; week 0), and three test visits (Visits 5, 6, and 7; weeks 4, 8, and 12).
At Visit 1 (week -3), after subjects have provided informed consent, medical history will be reviewed, and clinic visit procedures will be performed, including assessments of prior/current medication/supplement use, evaluations of inclusion/exclusion criteria, and a last menses query. Fasting (10-14 h) blood samples will be collected for assessment of FSH and estradiol levels. The Soy Food Frequency Questionnaire will be administered and subjects will be instructed to maintain their habitual diets (with the exception of avoiding soy foods) and physical activity patterns throughout the study period. Additionally, subjects will be dispensed the Insomnia Severity Index Questionnaire (ISIQ) and the VMS Diary to assess insomnia and VMS, respectively.
At Visit 2 (week -2), eligible subjects will be instructed to start the run-in placebo product for two weeks. Subjects will be also instructed to continue daily recording in the VMS Diary. At Visit 3 (week -1), the VMS Diary will be collected/reviewed to assess response to the run-in placebo product. Subjects who continue to meet the inclusion/exclusion criteria will be allowed to continue with the study and will be dispensed a sleep tracking device to wear for sleep/wake pattern evaluation.
At Visit 4 (week 0), eligible subjects will be randomized to one of the study products (Active or Placebo) and instructed to consume with water for 12 weeks. Additionally, the Pittsburg Sleep Quality Index (PSQI), RAND-36 Questionnaire, Profile of Mood States (POMS), Day-to-Day Impact of Vaginal Aging Questionnaire (DIVQ), Chalder Fatigue Scale, and Menopause-Specific Quality of Life (MENQOL) Questionnaire will be administered. The VMS Diary and ISIQ will be collected and reviewed.
At Visits 5 and 6 (weeks 4 and 8), the VMS Diary and ISIQ will be collected/reviewed, and the PSQI and MENQOL will be administered. Subjects will return to the clinic prior to Visit 7 (week 12) to receive the sleep tracking device to wear for sleep/wake pattern evaluation one week (7 d) prior to Visit 7 (week 12).
At Visit 7 (week 12), the VMS Diary and ISIQ will be collected and reviewed. The PSQI, RAND-36, POMS, DIVQ, Chalder Fatigue Scale, and MENQOL will be administered and study product will be collected/reviewed, and compliance will be determined. Additionally, the sleep tracker will be collected, and data will be downloaded for evaluation.
- Conditions
- Menopause
- Being tested
- Placebo, S-equol
- Keywords
- menopause
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
4 tablets/d (2 in the morning and 2 in the evening)
S-equolDietary supplement
4 tablets/d (2 in the morning and 2 in the evening), providing 10 mg S-equol total a day Other Names: •Equelle®
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo; Dietary Supplement: S-equol |
| Experimental | Experimental | S-equol Receives: Dietary Supplement: Placebo; Dietary Supplement: S-equol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vasomotor symptoms
Daily frequency of vasomotor symptoms, including hot flushes and night sweats
Measured: [Time Frame: Change from baseline to Week 12]
Secondary outcomes (23)
Vasomotor symptom
Daily frequency of vasomotor symptoms, including hot flushes and night sweats
Measured: [Time Frame: Change from baseline to Weeks 4 and 8]
Hot Flush
Daily frequency of hot flush
Measured: [Time Frame: Change from baseline to Weeks 4, 8, and 12]
Night Sweat
Daily frequency of night sweat
Measured: [Time Frame: Change from baseline to Weeks 4, 8, and 12]
Vasomotor symptom severity - number
Average number of moderate-to-severe VMS episode per day
Measured: [Time Frame: Change from baseline to Weeks 4, 8, and 12]
Vasomotor symptom severity - total score
Average of VMS severity total score
Measured: [Time Frame: Change from baseline to Weeks 4, 8, and 12]
Hot flush symptom severity - number
Average number of moderate-to-severe hot flush episode per day
Measured: [Time Frame: Change from baseline to Weeks 4, 8, and 12]
Hot flush severity - total score
Average of hot flush severity total score
Measured: [Time Frame: Change from baseline to Weeks 4, 8, and 12]
Night sweat severity - number
Average number of moderate-to-severe night sweat episode per day
Measured: [Time Frame: Change from baseline to Weeks 4, 8, and 12]
Night sweat severity - total score
Average night sweat severity total score
Measured: [Time Frame: Change from baseline to Weeks 4, 8, and 12]
Insomnia score
Average insomnia score per day obtained from Insomnia severity questionnaire (ISIQ)
Measured: [Time Frame: Change from baseline to Weeks 4, 8, and 12]
Sleep duration
Average sleep duration per day, obtained from sleep tracker
Measured: [Time Frame: Change from baseline to Week 12]
Actual sleep duration
Average actual sleep duration per day obtained from sleep tracker
Measured: [Time Frame: Change from baseline to Week 12]
Sleep efficiency
Average sleep efficiency per day obtained from sleep tracker
Measured: [Time Frame: Change from baseline to Week 12]
Sleep onset latency
Average sleep onset latency per day obtained from sleep tracker
Measured: [Time Frame: Change from baseline to Week 12]
Latency to persistent sleep
Average latency to persistent sleep per day obtained from sleep tracker
Measured: [Time Frame: Change from baseline to Week 12]
Wake after sleep onset
Average wake after sleep onset per day obtained from sleep tracker
Measured: [Time Frame: Change from baseline to Week 12]
Fatigue
Average fatigue score obtained from Chalder fatigue scale. Higher scores mean a worse outcome.
Measured: [Time Frame: Change from baseline to Week 12]
Sleep quality
Average sleep quality obtained from Pittsburgh sleep quality index
Measured: [Time Frame: Change from baseline to Weeks 4, 8, and 12]
Vaginal bothersome score
Average bothersome score obtained from Vaginal bothersome symptoms diary
Measured: [Time Frame: Change from baseline to Week 12]
Vaginal aging score
Average vaginal aging score obtained from Day-to-day impact vaginal aging questionnaire
Measured: [Time Frame: Change from baseline to Week 12]
Menopause-specific quality of life
Average score obtained from Menopause-specific quality of life
Measured: [Time Frame: Change from baseline to Weeks 4, 8, and 12]
General quality of life
Average score obtained from RAND-36 questionnaire
Measured: [Time Frame: Change from baseline to Week 12]
Mood
Average score obtained from Profile of mood states (POMS)
Measured: [Time Frame: Change from baseline to Weeks 4, 8, and 12]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start27 Mar 2019
- Primary completion22 May 2020
- Study completion22 May 2020
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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmavite LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biofortis, Merieux NutriSciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04516304
- Sponsor's protocol ID
- BIO-1811
- Status last verified
- Apr 2024
- First submitted
- 13 Aug 2020
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled Study to Assess a Nutritional Supplement on Vasomotor Symptoms In Perimenopausal and Menopausal Women
- ClinicalTrials.gov ID
- NCT04516304
- Acronym / sponsor ID
- BIO-1811
- Conditions
- Menopause
- Keywords
- menopause
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Pharmavite LLCIndustry (pharma, biotech, devices)
- Collaborators
- Biofortis, Merieux NutriSciences
- Study start
- 27 Mar 2019 (actual)
- Primary completion
- 22 May 2020 (actual)
- Study completion
- 22 May 2020 (actual)
- First posted
- 18 Aug 2020 (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.
Vasomotor symptoms (VMS), such as flushes, sweating, and sleep disturbances, are experienced by up to 80% of women during the menopausal transition. Night sweats, which are hot flushes that occur at night, can be particularly bothersome in women and contribute to disturbed sleep. These symptoms occur mainly during the 1-3 years prior to menopause (late perimenopause) and early menopause (~4 years after menstruation ceases). Many women look to supplements for the management of menopausal symptoms. Soy isoflavones and their metabolites are one category of dietary supplements that have been extensively studied for the management of VMS. The most active soy isoflavone is S-equol, which is not found directly in soy, but rather is the metabolite that is produced by gut microflora from consumption of the soy isoflavone daidzein. However, only 20-30% of US women are actually able to produce S-equol from the consumption of daidzein. Equelle® is a currently available dietary supplement that has S-equol as its active component, which allows the delivery of the active soy isoflavone metabolite directly without dependence on the gut microflora metabolism. The intention of this study is to assess the effect of a product containing S-equol on the management of VMS in normally healthy women.
Condition or disease: Vasomotor Symptoms
Intervention/treatment:
Dietary Supplement: S-equol Dietary Supplement: Placebo
Detailed description
This is a randomized, placebo-controlled, double-blind, parallel study, which will include a screening visit (Visit 1; week -3), a 2-week run-in period for baseline determination and assessment of placebo response (Visit 2; week -2; and Visit 3; week -1), one baseline visit (Visit 4; week 0), and three test visits (Visits 5, 6, and 7; weeks 4, 8, and 12).
At Visit 1 (week -3), after subjects have provided informed consent, medical history will be reviewed, and clinic visit procedures will be performed, including assessments of prior/current medication/supplement use, evaluations of inclusion/exclusion criteria, and a last menses query. Fasting (10-14 h) blood samples will be collected for assessment of FSH and estradiol levels. The Soy Food Frequency Questionnaire will be administered and subjects will be instructed to maintain their habitual diets (with the exception of avoiding soy foods) and physical activity patterns throughout the study period. Additionally, subjects will be dispensed the Insomnia Severity Index Questionnaire (ISIQ) and the VMS Diary to assess insomnia and VMS, respectively.
At Visit 2 (week -2), eligible subjects will be instructed to start the run-in placebo product for two weeks. Subjects will be also instructed to continue daily recording in the VMS Diary. At Visit 3 (week -1), the VMS Diary will be collected/reviewed to assess response to the run-in placebo product. Subjects who continue to meet the inclusion/exclusion criteria will be allowed to continue with the study and will be dispensed a sleep tracking device to wear for sleep/wake pattern evaluation.
At Visit 4 (week 0), eligible subjects will be randomized to one of the study products (Active or Placebo) and instructed to consume with water for 12 weeks. Additionally, the Pittsburg Sleep Quality Index (PSQI), RAND-36 Questionnaire, Profile of Mood States (POMS), Day-to-Day Impact of Vaginal Aging Questionnaire (DIVQ), Chalder Fatigue Scale, and Menopause-Specific Quality of Life (MENQOL) Questionnaire will be administered. The VMS Diary and ISIQ will be collected and reviewed.
At Visits 5 and 6 (weeks 4 and 8), the VMS Diary and ISIQ will be collected/reviewed, and the PSQI and MENQOL will be administered. Subjects will return to the clinic prior to Visit 7 (week 12) to receive the sleep tracking device to wear for sleep/wake pattern evaluation one week (7 d) prior to Visit 7 (week 12).
At Visit 7 (week 12), the VMS Diary and ISIQ will be collected and reviewed. The PSQI, RAND-36, POMS, DIVQ, Chalder Fatigue Scale, and MENQOL will be administered and study product will be collected/reviewed, and compliance will be determined. Additionally, the sleep tracker will be collected, and data will be downloaded for evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo, Dietary Supplement: S-equolPlacebo |
| Experimental | Experimental | Dietary Supplement: Placebo, Dietary Supplement: S-equolS-equol |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject is a perimenopausal or menopausal female experiencing specific menopausal-related VMS.
- Subject has a BMI of ≥18.5 to ≤38.0 kg/m2 at Visit 1 (week -3).
- At screening visit (Visit 1; week -3), subject reports to have 4 or more moderate to severe hot flushes/night sweats during 24 h prior to the visit. At Visit 3 (week -1), subject has ≥25 moderate to severe hot flushes/night sweats per week for one week between Visit 2 and 3 (weeks -2 and -1). At Visit 4 (week 0), subject has an average ≥28 moderate to severe hot flushes/night sweats per week for 2 weeks before Visit 4 (week 0).
- Subject is willing to maintain habitual diet (with the exception of restricted foods/beverages), physical activity patterns, and body weight during the study period.
- Subject is willing to abstain from using products (other than study product) that contains estrogen, progestin, or progesterone within 30 d prior to Visit 1 (week -3) and throughout the study trial.
Key exclusion criteria (16 listed)
- Subject has abnormal laboratory test results of clinical importance at Visit 1 (week -3) at the discretion of the Investigator.
- Subject has a history or presence of clinically important pulmonary (including uncontrolled asthma), cardiac (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), hepatic, renal, endocrine, hematologic, immunologic (including chronic inflammatory conditions), neurologic (such as Alzheimer's or Parkinson's disease), psychiatric (including depression and/or anxiety disorders) or biliary disorders, that, in the opinion of the Clinical Investigator, could interfere with the interpretation of the study results.
- Subject has a history or presence of any gastrointestinal condition that could potentially interfere with absorption of the study product (e.g., inflammatory bowel syndrome, celiac disease, history of gastric bypass surgery).
- Subject has a history of estrogen-dependent neoplasia, atypical ductual hyperplasia of the breast, or undiagnosed vaginal bleeding.
- Subject has a history of endometrial hyperplasia, melanoma, or uterine/endometrial breast or ovarian 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 |
|---|---|---|
| Placebo4 tablets/d (2 in the morning and 2 in the evening) | Dietary supplement | Experimental, Placebo |
| S-equol4 tablets/d (2 in the morning and 2 in the evening), providing 10 mg S-equol total a day Other Names: •Equelle® | Dietary supplement | Experimental, Placebo |
Primary outcome
Vasomotor symptoms
Time frame: [Time Frame: Change from baseline to Week 12]
Daily frequency of vasomotor symptoms, including hot flushes and night sweats
23 secondary outcomes
Vasomotor symptom
Time frame: [Time Frame: Change from baseline to Weeks 4 and 8]
Hot Flush
Time frame: [Time Frame: Change from baseline to Weeks 4, 8, and 12]
Night Sweat
Time frame: [Time Frame: Change from baseline to Weeks 4, 8, and 12]
Vasomotor symptom severity - number
Time frame: [Time Frame: Change from baseline to Weeks 4, 8, and 12]
Vasomotor symptom severity - total score
Time frame: [Time Frame: Change from baseline to Weeks 4, 8, and 12]
Hot flush symptom severity - number
Time frame: [Time Frame: Change from baseline to Weeks 4, 8, and 12]
Hot flush severity - total score
Time frame: [Time Frame: Change from baseline to Weeks 4, 8, and 12]
Night sweat severity - number
Time frame: [Time Frame: Change from baseline to Weeks 4, 8, and 12]
Night sweat severity - total score
Time frame: [Time Frame: Change from baseline to Weeks 4, 8, and 12]
Insomnia score
Time frame: [Time Frame: Change from baseline to Weeks 4, 8, and 12]
Sleep duration
Time frame: [Time Frame: Change from baseline to Week 12]
Actual sleep duration
Time frame: [Time Frame: Change from baseline to Week 12]
Sleep efficiency
Time frame: [Time Frame: Change from baseline to Week 12]
Sleep onset latency
Time frame: [Time Frame: Change from baseline to Week 12]
Latency to persistent sleep
Time frame: [Time Frame: Change from baseline to Week 12]
Wake after sleep onset
Time frame: [Time Frame: Change from baseline to Week 12]
Fatigue
Time frame: [Time Frame: Change from baseline to Week 12]
Sleep quality
Time frame: [Time Frame: Change from baseline to Weeks 4, 8, and 12]
Vaginal bothersome score
Time frame: [Time Frame: Change from baseline to Week 12]
Vaginal aging score
Time frame: [Time Frame: Change from baseline to Week 12]
Menopause-specific quality of life
Time frame: [Time Frame: Change from baseline to Weeks 4, 8, and 12]
General quality of life
Time frame: [Time Frame: Change from baseline to Week 12]
Mood
Time frame: [Time Frame: Change from baseline to Weeks 4, 8, and 12]
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 2024.
- 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 S-equol in people with Menopause, run by Pharmavite LLC 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 8 inclusion and 16 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 2024. 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?
Vasomotor symptoms (time frame: [Time Frame: Change from baseline to Week 12]). 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 4 Apr 2024.