COMPLETED

One Week Clinical Study in Subjects With Menopausal Symptoms

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

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).

Quick Facts

Study Start:2025-01-21

Study Completion:2025-04-22

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06794021

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.

Ages Eligible for Study:40 Years to 65 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Locations (Sites)

San Francisco Research Institute

San Francisco, California, 94127

United States

Collaborators and Investigators

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 Registration Dates

Study Start Date2025-01-21

Study Completion Date2025-04-22

Study Record Updates

Study Start Date2025-01-21

Study Completion Date2025-04-22

Terms related to this study

Additional Relevant MeSH Terms

Healthy
Menopause