A Randomized, Double Blind, Placebo Controlled, Clinical Study to Examine the Benefits of an Oral Product in Panelists With Menopausal Symptoms Including Vasomotor Symptoms (VMS).

Part of paid clinical trials in San Francisco, California.

Sponsor
Olly, PBC
Study ID
NCT07033013
Status
Recruiting

Conditions

  • Healthy

Eligibility Criteria

Sex
FEMALE
Age
40 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Placebo — DIETARY_SUPPLEMENT
    Placebo
  • Dietary Supplement with actives — DIETARY_SUPPLEMENT
    Dietary supplement containing EstroG-100 and GABA

Study Details

Randomized, Double-Blind, Placebo-Controlled, Single-Center Clinical Study with a Run-in Baseline, Daily Diary Log, and Validated Questionnaires (Greene GCS) with Oral Dietary Supplement

Key Dates

Start date
Jul 7, 2025
Status verified
Jul 2025
Primary completion
Jul 25, 2025
Completion
Aug 1, 2025

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Placebo Comparator: Placebo
    Instructions: Take 1 capsule when having a hot flash at the onset of a hot flash (not to exceed 1 capsule/day). Only treat 1 hot flash during a 24-hour period.
  • Active Comparator: Dietary Supplement with actives
    Instructions: Take 1 capsule when having a hot flash at the onset of a hot flash (not to exceed 1 capsule/day). Only treat 1 hot flash during a 24-hour period.

Primary Outcome Measure

24 hour effects following single dose of Mellow Menopause - Hot Flashes [ Time Frame: From baseline Day 7 to Treatement Day 1 (Day 8 of study) ]

Locations (1)

FacilityCityStateZIPSite coordinators
San Francisco Research InstituteSan FranciscoCalifornia94132
John Ademola

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