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_SUPPLEMENTPlacebo
- Dietary Supplement with actives — DIETARY_SUPPLEMENTDietary 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: PlaceboInstructions: 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 activesInstructions: 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| San Francisco Research Institute | San Francisco | California | 94132 | John Ademola |
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