One Week Clinical Study in Subjects With Menopausal Symptoms

Not Applicable

Recruiting

• Conditions: Healthy; Menopause

• Registration Number: NCT06794021
• Lead Sponsor: Olly, PBC

Brief 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)

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01
• Primary Completion: 2025-01
• Study First Submitted: 2025-01-06
• Study First Submitted QC: 2025-01-20
• Last Update Submitted: 2025-01-20
• Study First Posted: 2025-01-27
• Last Update Posted: 2025-01-27
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Daily Diary - 24hr	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.
Mobile App - 24hr	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.

Secondary Outcome Measures

Name	Time	Method
Daily Dairy - Days 1-6	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
Mobile App - Days 1-6	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
Green Climacteric Scale (GCS) - Days 1-6	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
Menopause-Specific Quality of Life (MENQOL) - Days 1-6	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

Trial Locations

Locations (1)

San Francisco Research Institute; 🇺🇸 San Francisco, California, United States