Haelan 951 for Menopause Symptoms in Peri- and Postmenopausal Women (NCT07751029) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Haelan 951 for Menopause Symptoms in Peri- and Postmenopausal Women
United States25 participantsStarted 2026-08
Plain-language 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.
Who can participate
Age range
45 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.
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.