NCT06794021

One Week Clinical Study in Subjects With Menopausal Symptoms

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Olly, PBC · Industry
• Sex: Female
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to Examine the Benefits of an Oral Product in Subjects With Menopausal Symptoms. The main questions it aims to answer are: 1. To assess the efficacy for improvement of menopausal vasomotor symptoms within 24 hours compared to placebo through Daily Diary and Mobile Application 2. To assess the efficacy for improvement of menopausal vasomotor symptoms hours compared to placebo through days 2-6 Daily Diary and Mobile Application 3. To assess the efficacy of the investigation product on stress/anxiety, mood swings, headaches compared to placebo through days 1-6 and with use of Daily Diary, Mobile Application and validated questionnaires (GCS, MENQOL). 4. To assess the efficacy of the investigation product on mood, stress and sleep at 7 days post treatment using validated questionnaires (PSQI, PSS, POMS)

Conditions

• Healthy
• Menopause

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Dietary Supplement with Proprietary Herbal Extract Blend and GABA	Eligible subjects will receive active product to take daily for seven days
OTHER	Placebo	Eligible subjects will receive Placebo to take daily for seven days

Timeline

• Start date: 2025-01-21
• Primary completion: 2025-01-31
• Completion: 2025-04-22
• First posted: 2025-01-27
• Last updated: 2025-07-15

Locations

1 site across 1 country: United States