Haelan 951 for Menopause
(H951-MENO Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to assess how a fermented soy product, Haelan 951, affects menopause symptoms such as hot flashes and sleep quality. Researchers seek data from women who have experienced menopause-related symptoms, like frequent hot flashes, for at least three months. Participants will take Haelan 951 daily for 30 days and report their experiences using a smartphone app. Women who have gone through menopause or are in transition, live in the Kansas City area, and can manage symptoms without starting new treatments might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to understanding menopause symptom management.
Will I have to stop taking my current medications?
If you are currently using hormone replacement therapy (HRT) or menopause-related supplements, you will need to stop them at least 30 days before starting the trial. If you are on a stable regimen of menopause-related supplements for at least 3 months, you can continue them unchanged. Other medications that might interact with soy-derived foods may also need to be adjusted.
What prior data suggests that Haelan 951 is safe for menopausal women?
Research has shown that Haelan 951, a fermented soy food, has been studied for its effects on various conditions. In these studies, using Haelan 951 at levels below 8% did not cause any harmful effects, suggesting it is generally safe at these amounts. As a food rather than a drug, Haelan 951 may have a favorable safety profile.
Although detailed information on side effects is limited, some individuals have reported mild and temporary digestive issues. Such effects are common when trying new dietary products.
Overall, current evidence suggests that Haelan 951 is safe to consume at the studied levels. However, it is important to consult a healthcare provider before starting any new treatment.12345Why are researchers excited about this trial?
Unlike the standard hormone replacement therapies for menopause, Haelan 951 is a fermented soy product that offers a more natural approach to managing symptoms. Researchers are excited about Haelan 951 because it leverages the benefits of soy, which contains natural compounds called phytoestrogens that can mimic estrogen in the body. This treatment is unique because it is consumed as a conventional food product, making it potentially more accessible and with fewer side effects than synthetic hormone treatments. Additionally, the use of wearable devices and electronic patient-reported outcomes in monitoring its effects represents a modern, patient-friendly approach to treatment.
What evidence suggests that Haelan 951 might be an effective treatment for menopausal symptoms?
Research has shown that soy isoflavones, the main ingredient in Haelan 951, can help reduce menopause symptoms like hot flashes. One study found that soy isoflavones decreased the severity of hot flashes by about 26% compared to a placebo. Other studies indicate that isoflavones can also reduce major menopause symptoms, especially those related to temperature changes, such as hot flashes and night sweats. While results can vary, this evidence suggests that Haelan 951, which participants in this trial will receive, may improve life for women experiencing menopause.35678
Who Is on the Research Team?
Kelly James, MD
Principal Investigator
Spectrum Clinical Research
Are You a Good Fit for This Trial?
This trial is for women who are going through or have finished menopause and are experiencing symptoms like hot flashes or trouble sleeping. Participants should be generally healthy and able to report their symptoms.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Haelan 951 daily for 30 consecutive days with remote monitoring and assessments
Follow-up
Participants are monitored for changes in vasomotor symptoms and sleep quality after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Haelan 951
Trial Overview
The study tests daily use of Haelan 951, a fermented soy drink, to see if it helps with menopause-related hot flashes, sleep problems, and overall quality of life. All participants receive the product; there is no comparison group.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Spectrum Clinical Research, LLC
Lead Sponsor
Nextrials, Inc.
Industry Sponsor
Haelan Products, Inc.
Industry Sponsor
NexTrial AI Inc
Collaborator
Citations
1.
ctv.veeva.com
ctv.veeva.com/study/haelan-951-for-menopause-symptoms-in-peri-and-postmenopausal-womenHaelan 951 for Menopause Symptoms in Peri
The study will collect descriptive data on participant-reported outcomes over the study period to assess the feasibility and potential effects ...
Haelan 951 for Menopause Symptoms in Peri- and ...
The study will collect descriptive data on participant-reported outcomes over the study period to assess the feasibility and potential ...
Top Hot Flashes Clinical Trials | Power
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 ...
Effects of soy isoflavones on menopausal symptoms in ... - PMC
Some studies report substantial improvements in vasomotor symptoms and other menopausal disorders, whereas others show negligible or no benefits ...
H951-MENO | Effects of Haelan 951 on Menopausal ...
This study aims to evaluate the effects of Haelan 951 on the frequency of moderate-to-severe vasomotor symptoms, such as hot flashes, in peri- ...
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The flavonoid beverage Haelan 951 induces growth arrest ...
Haelan concentrations lower than 8 % showed no cytotoxic effects, whereas higher concentrations led to necrosis.
8.
irp.cdn-website.com
irp.cdn-website.com/a8ace6ea/files/uploaded/Haelan+951+Clinical+Trial+Announcement.pdfAfter Nearly 40 Years, Haelan 951 Enters a Menopause ...
women found soy isoflavones effective for treating menopausal symptoms overall, with signals across hot flashes, depressive symptoms, and excessive sweating.
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