One Week Clinical Study in Subjects With Menopausal Symptoms

July 11, 2025 updated by: Olly, PBC

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).

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94127
        • San Francisco Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy Females aged 40 to 65 years,
  • Self-reporting menopausal symptoms (> 5 hot flushes per day) and have been present for a minimum of previous 60 days prior to baseline visit.
  • Reporting a variable cycle length of > 7 days different from normal
  • BMI 20-40 kg/m2
  • Able to read, understand, and complete the study questionnaire and records.
  • Able to understand the study procedures.
  • Able to comply with all study requirements.
  • Written informed consent to participate in the study.
  • Willingness to actively participate in the study and to come to the scheduled visits.

Exclusion Criteria:

  • Pregnancy or breastfeeding.
  • Immune insufficiency
  • Women of childbearing potential including those still having a menstrual cycle on a regular basis who are not perimenopausal, menopausal or post-menopausal.
  • History of hysterectomy
  • Women on hormone replacement therapy
  • Use of systemic corticosteroids or immunosuppressant drugs.
  • Other diseases or medications that might directly interfere in the study or put the subject's health under risk.
  • Employees of the institute or the brand owner or the manufactures of the product
  • Cardiovascular-, chronic liver-, thyroid or kidney diseases; a history of cancer; a disease or condition that could influence the participants' ability to follow the study protocol,
  • Alcohol or drug abuse
  • Use of hormonal contraceptives within the last 3 months
  • Use of other menopause supplements
  • BP ≥160/110 mmHg
  • Oophorectomy or amenorrhea > two years. Note- Habitual medicine and supplement intake will be registered prior to inclusion in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Oral dietary supplement. 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.
Other: Placebo
Eligible subjects will receive Placebo to take daily for seven days
Active Comparator: Dietary Supplement with Proprietary Herbal Extract Blend and GABA
Oral dietary supplement. 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.
Dietary supplement: Dietary Supplement with Proprietary Herbal Extract Blend and GABA
Eligible subjects will receive active product to take daily for seven days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily Diary - 24hr
Time Frame: from enrollment to the end of study at seven days
To assess changes in menopausal vasomotor symptoms scores within 24 hours compared to placebo through Daily Diary.
from enrollment to the end of study at seven days
Mobile App - 24hr
Time Frame: from enrollment to the end of study at seven days
To assess changes in menopausal vasomotor symptoms scores within 24 hours compared to placebo through Mobile Application.
from enrollment to the end of study at seven days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily Dairy - Days 1-6
Time Frame: from enrollment to the end of study at seven days
To assess changes in menopausal vasomotor symptoms, stress/anxiety, mood swings, and headaches scores compared to placebo through days 1-6
from enrollment to the end of study at seven days
Mobile App - Days 1-6
Time Frame: from enrollment to the end of study at seven days
To assess changes in menopausal vasomotor symptoms, stress/anxiety, mood swings, and headaches scores compared to placebo through days 1-6
from enrollment to the end of study at seven days
Green Climacteric Scale (GCS) - Days 1-6
Time Frame: from enrollment to the end of study at seven days
To assess changes in stress/anxiety, mood swings, and headaches scores compared to placebo through days 1-6
from enrollment to the end of study at seven days
Menopause-Specific Quality of Life (MENQOL) - Days 1-6
Time Frame: from enrollment to the end of study at seven days
To assess changes in menopausal vasomotor symptoms, stress/anxiety, mood swings, and headaches scores compared to placebo through days 1-6
from enrollment to the end of study at seven days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pittsburgh Sleep Quality Index (PSQI) - Day 7
Time Frame: from enrollment to the end of study at seven days
To assess changes on mood, stress and sleep scores at 7 days post treatment
from enrollment to the end of study at seven days
Perceived Stress Scale (PSS) - Day 7
Time Frame: from enrollment to the end of study at seven days
To assess changes on mood, stress and sleep scores at 7 days post treatment
from enrollment to the end of study at seven days
Profile of Mood States questionnaire (POMS) - Day 7
Time Frame: from enrollment to the end of study at seven days
To assess changes on mood, stress and sleep scores at 7 days post treatment
from enrollment to the end of study at seven days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Olly, PBC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2025

Primary Completion (Actual)

January 31, 2025

Study Completion (Actual)

April 22, 2025

Study Registration Dates

First Submitted

January 6, 2025

First Submitted That Met QC Criteria

January 20, 2025

First Posted (Actual)

January 27, 2025

Study Record Updates

Last Update Posted (Actual)

July 15, 2025

Last Update Submitted That Met QC Criteria

July 11, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • UNLV20241205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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