Spectrum Clinical Research, LLC
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.
This is a decentralized, site-anchored hybrid, open-label, single-arm proof-of-concept study 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. Approximately 25 eligible participants will be enrolled and followed over a 30-day treatment period. Following informed consent and screening at the clinical research site, eligible participants will receive Haelan 951 along with study-specific training, wearab…
Inclusion Criteria: 1. Female sex assigned at birth, ages 45-65 years inclusive at the time of consent. 2. 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. 3. Self-reported vasomotor symptoms ≥3 months' duration prior to Screening, averaging ≥4 episodes per 24-hour period over the 7 days prior to Screening. 4. Willing and able to consume the investigational product as directed (30 mL twice daily, empty stomach, 30 days). 5. Willing and able to complete daily eCOA entries in the…
Haelan 951 is a fermented soy product administered orally once daily for 30 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.
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