25 Participants NeededMy employer runs this trial

Haelan 951 for Menopause

(H951-MENO Trial)

JS
KK
Overseen ByKelly Kush, CCRC
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Spectrum Clinical Research, LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

KJ

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

I am willing to avoid starting new menopause treatments during the study.
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
See 6 more

Exclusion Criteria

Known soy allergy or hypersensitivity to any component of Haelan 951 (Purified Water, Organic Cultured Soy Powder, Yeast, Salt)
I am not taking medicines that could interact with soy foods, or my doses are stable.
Other reasons judged by the PI, with documented rationale per ICH E6(R3) 4.2.1, to compromise safety, well-being, or scientific validity
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (in-person)

Treatment

Participants receive Haelan 951 daily for 30 consecutive days with remote monitoring and assessments

4 weeks
Remote monitoring with wearable devices and ePRO assessments

Follow-up

Participants are monitored for changes in vasomotor symptoms and sleep quality after treatment

1 week
Virtual follow-up assessments

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

Group I: Haelan 951Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Spectrum Clinical Research, LLC

Lead Sponsor

Nextrials, Inc.

Industry Sponsor

Trials
2
Recruited
500+

Haelan Products, Inc.

Industry Sponsor

Trials
1
Recruited
6+

NexTrial AI Inc

Collaborator

Citations

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