Haelan 951 for Menopause Symptoms in Peri- and Postmenopausal Women
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-65
SponsorSpectrum Clinical Research, LLC
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Haelan 951
Treatment groups
25 Participants
are divided into 1 treatment groupSponsors and collaborators
Spectrum Clinical Research, LLC
Lead sponsor
Haelan Products, Inc.
Collaborator
NexTrial AI Inc
Collaborator
Source ClinicalTrials.gov