Haelan 951 for Menopause Symptoms in Peri- and Postmenopausal Women

Part of paid clinical trials in Kansas City, Missouri.

Sponsor
Spectrum Clinical Research, LLC
Study ID
NCT07751029
Status
Not Yet Recruiting

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Conditions

  • Menopause
  • Menopause Hot Flashes
  • Menopause Related Conditions

Eligibility Criteria

Sex
FEMALE
Age
45 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Haelan 951 — DIETARY_SUPPLEMENT
    Haelan 951 is a fermented soy product administered orally once daily for 45 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.

Study Details

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.

Key Dates

First listed
Aug 6, 2026
Start date
Aug 31, 2026
Status verified
Aug 2026
Primary completion
Sep 30, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Haelan 951
    Participants will receive Haelan 951, a fermented soy conventional food product, for 45 consecutive days. Following an in-person screening and baseline visit, participants will complete the study using a decentralized, site-anchored hybrid model with electronic patient-reported outcome (ePRO) assessments, wearable device monitoring, and scheduled remote follow-up.

Primary Outcome Measure

Vasomotor Symptom Episode [ Time Frame: Baseline to Day 30 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Spectrum Clinical ResearchKansas CityMissouri64118
Jovanna Schlossenberg, MSc
[email protected]
8155626466
Kelly Kush, CCRC
[email protected]
8155626466
Kelly James, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Spectrum Clinical Research· Kansas City, MO

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