Haelan 951 for Menopause Symptoms in Peri- and Postmenopausal Women
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Haelan 951
Dietary supplementHaelan 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.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Haelan 951Experimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline to Day 30Secondary outcomes
1
Sleep
Change from Baseline to Day 30 in self-reported sleep, captured daily by the H951 Sleep Assessment (bedtime, sleep latency, wake time, number of awakenings, awakenings attributed to hot flashes or night sweats,
Time frame
Baseline to Day 30Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Spectrum Clinical Research, LLC
Lead sponsor
Haelan Products, Inc.
Collaborator
NexTrial AI Inc
Collaborator
Source ClinicalTrials.gov