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One Week Clinical Study in Subjects With Menopausal Symptoms

NCT06794021 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-07-15

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Olly, PBC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-21
Primary Completion
2025-01-31
Completion
2025-04-22

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06794021 on ClinicalTrials.gov