Haelan 951 for Menopause Symptoms in Peri- and Postmenopausal Women

NCT07751029 | Not Yet Recruiting

• 1 other identifier: H951-MENO-001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Menopause; Menopause Hot Flashes; Menopause Related Conditions

Keywords

Menopause; Perimenopause; Vasomotor Symptoms; Hot Flashes; Sleep Quality; Quality of Life; Haelan 951; Fermented Soy; Conventional Food; Decentralized Clinical Trial; Wearable Technology

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to Day 30

Secondary Outcomes (1)

• Sleep

  Baseline to Day 30

Study Arms (1)

Haelan 951

EXPERIMENTAL

Participants will receive Haelan 951, a fermented soy conventional food product, for 45 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.

Dietary Supplement: Haelan 951

Interventions

Haelan 951 DIETARY_SUPPLEMENT

Haelan 951 is a fermented soy product administered orally once daily for 45 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.

Haelan 951

Eligibility Criteria

• Age: 45 Years - 65 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Spectrum Clinical Research, LLC: lead
• Nextrials, Inc.: collaborator
• Haelan Products, Inc.: collaborator

Study Sites (1)

Spectrum Clinical Research

Kansas City, Missouri, 64118, United States

Location

Related Links

• Study website providing participant information, study updates, eligibility information, and recruitment resources for the Haelan 951 menopause study.

MeSH Terms

Conditions

Hot Flashes; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Kelly James, MD

  Spectrum Clinical Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jovanna Schlossenberg, MSc

CONTACT

18155626466; jovanna@spectrumclinicalresearch.com

Kelly Kush, CCRC

CONTACT

8155626466; kelly@spectrumclinicalresearch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 6, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: De-identified individual participant data and supporting documentation will be available beginning 12 months after publication of the primary study results or 24 months after study completion, whichever occurs first, and will remain available for 5 years
• Access Criteria: Access to de-identified individual participant data will be provided to qualified researchers upon reasonable request for scientifically sound research. Requests will be reviewed by the study sponsor. Approved requests will require execution of a data use agreement to protect participant confidentiality and comply with applicable laws and regulations.

Locations

US (1)