Haelan 951 for Menopause Symptoms in Peri- and Postmenopausal Women

Inclusion criteria

• 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.

Exclusion criteria

• 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.