MenopauseH951-MENONCT07751029
Haelan 951 for Menopause Symptoms in Peri- and Postmenopausal Women
A study testing Haelan 951 in people with Menopause and Menopause Hot Flashes, run by Spectrum Clinical Research, LLC at 1 site in United States.
Trial summary
This proof-of-concept, open-label, single-arm study is designed to evaluate the effects of daily consumption of Haelan 951, a fermented soy conventional food product, on self-reported menopausal vasomotor symptoms, sleep quality, and health-related quality of life in peri- and postmenopausal women. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Menopause, Menopause Hot Flashes, Menopause Related Conditions
- What is being tested?
- Haelan 951
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2026to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female sex assigned at birth, ages 45-65 years inclusive at the time of consent.
- Post-menopausal (≥12 consecutive months amenorrhea, STRAW+10 stage +1) OR peri-menopausal (STRAW+10 stages -2 or -1) at consent. PI to confirm staging at Screening.
- Self-reported vasomotor symptoms ≥3 months' duration prior to Screening, averaging ≥4 episodes per 24-hour period over the 7 days prior to Screening.
- Willing and able to consume the investigational product as directed (30 mL twice daily, empty stomach, 30 days).
- Willing and able to complete daily eCOA entries in the study application and to wear the study wearable throughout the Treatment period.
- Possession of (or willingness to use) a personal smartphone running iOS 16+ or Android 12+, with reliable daily internet access.
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- Resident of the Kansas City metropolitan area [30- 45 mile radius] and able to travel to Spectrum Clinical Research for a single onsite Participant Onboarding Visit.
- Able to read, understand, and provide written informed consent in English at approximately an 8th-grade reading level.
- Willing to abstain from initiation of any new HRT, menopause-related supplement, or other menopause-related therapeutic intervention for the study duration.
Who cannot join
- Pre-menopausal status (STRAW+10 stage -3 or earlier).
- Current pregnancy, planning pregnancy during the study, or breastfeeding.
- Current use of any systemic or topical HRT. Required wash-out prior to Day 1: 30 days systemic and 30 days topical/local, aligned with the Screening period and the 30-day study duration; the PI may extend for an individual on documented clinical rationale per ICH E6(R3) 4.2.1.
- Current use of any menopause-related dietary supplement within 30 days prior to Day 1, unless on a stable regimen ≥3 months and willing to maintain it unchanged (documented in medical history).
- Known soy allergy or hypersensitivity to any component of Haelan 951 (Purified Water, Organic Cultured Soy Powder, Yeast, Salt).
- History of estrogen- or progesterone-receptor-positive breast cancer; active malignancy of any type; or current systemic chemotherapy, immunotherapy, or radiation therapy.
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- Heavy alcohol use (≥3 alcoholic beverages/day on average, per NIAAA definitions).
- Major surgical procedure or hospitalization within 90 days prior to Screening, or any unresolved condition that the PI judges would compromise safety or interpretation of endpoints.
- Documented uncontrolled or unstable medical condition (e.g., uncontrolled cardiovascular disease; CKD stage 3b or worse; moderate-to-severe hepatic impairment; active autoimmune disease on systemic immunosuppression), established from medical history and PI clinical assessment.
- Current use of medications with documented potential for clinically significant interaction with soy-derived foods (thyroid replacement unless dose-stable ≥6 weeks with 4-hour separation; oral anticoagulants on non-stable dose; MAOIs; tamoxifen or other hormone-modulating cancer therapies).
- Current or recent (within 30 days) participation in another interventional clinical study.
- Inability to provide informed consent (cognitive impairment, language barrier - materials are English-only - or other reason per PI judgment).
- Other reasons judged by the PI, with documented rationale per ICH E6(R3) 4.2.1, to compromise safety, well-being, or scientific validity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Spectrum Clinical Research
Kansas City, Missouri, 64118
Jovanna Schlossenberg, MSc, 8165626466, jovanna_schlossenberg@hms.harvard.edu
Kelly Kush, CCRC, 8165626466, kelly@spectrumclinicalresearch.com
About this study
Official title: A Decentralized, Site-Anchored Hybrid, Open-Label, Single-Arm Proof-of-Concept Study Evaluating the Effect of Haelan 951 - a Fermented Soy Conventional Food Product - on Self-Reported Menopausal Vasomotor and Sleep-Related Outcomes in Post- and Peri-Menopausal Women
This proof-of-concept, open-label, single-arm study is designed to evaluate the effects of daily consumption of Haelan 951, a fermented soy conventional food product, on self-reported menopausal vasomotor symptoms, sleep quality, and health-related quality of life in peri- and postmenopausal women. The study will collect descriptive data on participant-reported outcomes over the study period to assess the feasibility and potential effects of Haelan 951 in supporting menopausal wellness. The study is not intended to evaluate the treatment, prevention, or cure of any disease.
Read the detailed description
This is a decentralized, site-anchored hybrid, open-label, single-arm proof-of-concept study designed to evaluate the effects of daily consumption of Haelan 951, a fermented soy conventional food product, on self-reported menopausal vasomotor symptoms, sleep quality, and health-related quality of life in peri- and postmenopausal women.
Approximately 25 eligible participants will be enrolled and followed over a 30-day treatment period. Following informed consent and screening at the clinical research site, eligible participants will receive Haelan 951 along with study-specific training, wearable device setup, and electronic patient-reported outcome (ePRO) instructions. Subsequent study activities will primarily occur remotely using decentralized clinical trial methods, including electronic diaries, validated questionnaires, wearable technology, scheduled telehealth contacts, and virtual follow-up assessments.
The primary objective is to generate descriptive scientific evidence regarding changes in participant-reported vasomotor symptoms following daily consumption of Haelan 951. Secondary objectives include evaluating participant-reported sleep quality, menopause-related quality of life, treatment satisfaction, adherence, and overall feasibility of conducting a decentralized hybrid clinical study utilizing remote data collection technologies.
Study endpoints consist primarily of validated participant-reported outcome measures and continuously collected physiologic data obtained through study-provided wearable devices. Data collected during the study will be used to characterize changes over time and to estimate effect sizes for future controlled clinical investigations.
Haelan 951 is being evaluated as a fermented soy conventional food product intended to support general wellness in peri- and postmenopausal women. This proof-of-concept study is exploratory in nature and is not designed to establish efficacy for the treatment, cure, mitigation, or prevention of disease. Any future commercial communication based on study findings will be limited to permissible structure/function statements and will comply with applicable U.S. Food and Drug Administration regulations governing conventional food products.
- Being tested
- Haelan 951
- Keywords
- Menopause, Perimenopause, Vasomotor Symptoms, Hot Flashes, Sleep Quality, Quality of Life, Haelan 951, Fermented Soy, Conventional Food, Decentralized Clinical Trial, Wearable Technology
- Medical subject headings
- Hot Flashes, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Haelan 951Dietary supplement
Haelan 951 is a fermented soy product administered orally once daily for 30 days. Participants will consume the study product according to the protocol to evaluate its effects on self-reported menopausal vasomotor symptoms, sleep quality, and health-related quality of life in peri- and postmenopausal women.
| Study group | Role | What they receive |
|---|---|---|
| Haelan 951 | Experimental | Participants will receive Haelan 951, a fermented soy conventional food product, for 30 consecutive days. Following an in-person screening and baseline visit, participants will complete the study using a decentralized, site-anchored hybrid model with electronic patient-reported outcome (ePRO) assessments, wearable device monitoring, and scheduled remote follow-up. Receives: Dietary Supplement: Haelan 951 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vasomotor Symptom Episode
Change from Baseline to Day 30 in the daily frequency of moderate-to-severe vasomotor symptom episodes, captured by the H951 Daily Vasomotor Symptom Diary.
Measured: Baseline to Day 30
Secondary outcomes (1)
Sleep
Change from Baseline to Day 30 in self-reported sleep, captured daily by the H951 Sleep Assessment (bedtime, sleep latency, wake time, number of awakenings, awakenings attributed to hot flashes or night sweats,
Measured: Baseline to Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start21 Sep 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a decentralized, site-anchored hybrid, open-label, single-arm proof-of-concept study. All enrolled participants will receive Haelan 951 for 45 days. Following an in-person screening and baseline visit, study procedures will be conducted primarily through decentralized methods, including electronic patient-reported outcome (ePRO) assessments, wearable device data collection, remote study contacts, and telehealth follow-up. No randomization or comparator arm is included. The study is designed to generate descriptive data regarding the feasibility, safety, adherence, and participant-reported outcomes associated with daily consumption of Haelan 951 in peri- and postmenopausal women.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spectrum Clinical Research, LLC
- Sponsor type
- Research network
- Collaborators
- Haelan Products, Inc., NexTrial AI Inc
- Responsible party
- Sponsor
- Investigators
- Kelly James, MD, Principal investigator, Spectrum Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07751029
- Sponsor's protocol ID
- H951-MENO-001
- Acronym
- H951-MENO
- Status last verified
- Sep 2026
- First submitted
- 28 Jul 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in publications, after de-identification, may be made available to qualified researchers upon reasonable request. Data requests will be reviewed by the study sponsor, and approved requests will require a data use agreement to protect participant confidentiality and comply with applicable laws and regulations.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Decentralized, Site-Anchored Hybrid, Open-Label, Single-Arm Proof-of-Concept Study Evaluating the Effect of Haelan 951 - a Fermented Soy Conventional Food Product - on Self-Reported Menopausal Vasomotor and Sleep-Related Outcomes in Post- and Peri-Menopausal Women
- ClinicalTrials.gov ID
- NCT07751029
- Acronym / sponsor ID
- H951-MENO / H951-MENO-001
- Keywords
- Menopause, Perimenopause, Vasomotor Symptoms, Hot Flashes, Sleep Quality, Quality of Life, Haelan 951, Fermented Soy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Spectrum Clinical Research, LLCResearch network
- Collaborators
- Haelan Products, Inc., NexTrial AI Inc
- Study start
- 21 Sep 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 6 Aug 2026 (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.
This proof-of-concept, open-label, single-arm study is designed to evaluate the effects of daily consumption of Haelan 951, a fermented soy conventional food product, on self-reported menopausal vasomotor symptoms, sleep quality, and health-related quality of life in peri- and postmenopausal women. The study will collect descriptive data on participant-reported outcomes over the study period to assess the feasibility and potential effects of Haelan 951 in supporting menopausal wellness. The study is not intended to evaluate the treatment, prevention, or cure of any disease.
Detailed description
This is a decentralized, site-anchored hybrid, open-label, single-arm proof-of-concept study designed to evaluate the effects of daily consumption of Haelan 951, a fermented soy conventional food product, on self-reported menopausal vasomotor symptoms, sleep quality, and health-related quality of life in peri- and postmenopausal women.
Approximately 25 eligible participants will be enrolled and followed over a 30-day treatment period. Following informed consent and screening at the clinical research site, eligible participants will receive Haelan 951 along with study-specific training, wearable device setup, and electronic patient-reported outcome (ePRO) instructions. Subsequent study activities will primarily occur remotely using decentralized clinical trial methods, including electronic diaries, validated questionnaires, wearable technology, scheduled telehealth contacts, and virtual follow-up assessments.
The primary objective is to generate descriptive scientific evidence regarding changes in participant-reported vasomotor symptoms following daily consumption of Haelan 951. Secondary objectives include evaluating participant-reported sleep quality, menopause-related quality of life, treatment satisfaction, adherence, and overall feasibility of conducting a decentralized hybrid clinical study utilizing remote data collection technologies.
Study endpoints consist primarily of validated participant-reported outcome measures and continuously collected physiologic data obtained through study-provided wearable devices. Data collected during the study will be used to characterize changes over time and to estimate effect sizes for future controlled clinical investigations.
Haelan 951 is being evaluated as a fermented soy conventional food product intended to support general wellness in peri- and postmenopausal women. This proof-of-concept study is exploratory in nature and is not designed to establish efficacy for the treatment, cure, mitigation, or prevention of disease. Any future commercial communication based on study findings will be limited to permissible structure/function statements and will comply with applicable U.S. Food and Drug Administration regulations governing conventional food products.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a decentralized, site-anchored hybrid, open-label, single-arm proof-of-concept study. All enrolled participants will receive Haelan 951 for 45 days. Following an in-person screening and baseline visit, study procedures will be conducted primarily through decentralized methods, including electronic patient-reported outcome (ePRO) assessments, wearable device data collection, remote study contacts, and telehealth follow-up. No randomization or comparator arm is included. The study is designed to generate descriptive data regarding the feasibility, safety, adherence, and participant-reported outcomes associated with daily consumption of Haelan 951 in peri- and postmenopausal women.
| Arm | Type | Receives |
|---|---|---|
| Haelan 951 | Experimental | Dietary Supplement: Haelan 951Participants will receive Haelan 951, a fermented soy conventional food product, for 30 consecutive days. Following an in-person screening and baseline visit, participants will complete the study using a decentralized, site-anchored hybrid model with electronic patient-reported outcome (ePRO) assessments, wearable device monitoring, and scheduled remote follow-up. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female sex assigned at birth, ages 45-65 years inclusive at the time of consent.
- Post-menopausal (≥12 consecutive months amenorrhea, STRAW+10 stage +1) OR peri-menopausal (STRAW+10 stages -2 or -1) at consent. PI to confirm staging at Screening.
- Self-reported vasomotor symptoms ≥3 months' duration prior to Screening, averaging ≥4 episodes per 24-hour period over the 7 days prior to Screening.
- Willing and able to consume the investigational product as directed (30 mL twice daily, empty stomach, 30 days).
- Willing and able to complete daily eCOA entries in the study application and to wear the study wearable throughout the Treatment period.
Key exclusion criteria (13 listed)
- Pre-menopausal status (STRAW+10 stage -3 or earlier).
- Current pregnancy, planning pregnancy during the study, or breastfeeding.
- Current use of any systemic or topical HRT. Required wash-out prior to Day 1: 30 days systemic and 30 days topical/local, aligned with the Screening period and the 30-day study duration; the PI may extend for an individual on documented clinical rationale per ICH E6(R3) 4.2.1.
- Current use of any menopause-related dietary supplement within 30 days prior to Day 1, unless on a stable regimen ≥3 months and willing to maintain it unchanged (documented in medical history).
- Known soy allergy or hypersensitivity to any component of Haelan 951 (Purified Water, Organic Cultured Soy Powder, Yeast, Salt).
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 |
|---|---|---|
| Haelan 951Haelan 951 is a fermented soy product administered orally once daily for 30 days. Participants will consume the study product according to the protocol to evaluate its effects on self-reported menopausal vasomotor symptoms, sleep quality, and health-related quality of life in peri- and postmenopausal women. | Dietary supplement | Haelan 951 |
Primary outcome
Vasomotor Symptom Episode
Time frame: Baseline to Day 30
Change from Baseline to Day 30 in the daily frequency of moderate-to-severe vasomotor symptom episodes, captured by the H951 Daily Vasomotor Symptom Diary.
1 secondary outcome
Sleep
Time frame: Baseline to Day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Study website providing participant information, study updates, eligibility information, and recruitment resources for the Haelan 951 menopause study.Link provided by the sponsor.
- Study website providing participant information, study updates, eligibility information, and recruitment resources for the Haelan 951 menopause study.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in publications, after de-identification, may be made available to qualified researchers upon reasonable request. Data requests will be reviewed by the study sponsor, and approved requests will require a data use agreement to protect participant confidentiality and comply with applicable laws and regulations.
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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.
Kelly James, MD principal investigator
Spectrum Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Haelan 951 in people with Menopause and Menopause Hot Flashes, run by Spectrum Clinical Research, 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 9 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: looking for participants now, as of the sponsor's last update on 11 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jovanna Schlossenberg, MSc (18165626466, jovanna@spectrumclinicalresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vasomotor Symptom Episode (time frame: Baseline to Day 30). 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 11 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.