Randomized Placebo Controlled Clinical Study of an Oral Product in Subjects With Menopausal Symptoms

Not Applicable

Completed

• Conditions: Menopausal Symptoms

• Registration Number: NCT06787443
• Lead Sponsor: Olly, PBC

Brief Summary

The objective of this study is to assess the safety and effectiveness of a dietary supplement for symptom relief in subjects with menopausal symptoms over the course of five weeks of continuous daily use.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-10
• Primary Completion: 2024-06-24
• Study Completion: 2024-06-24
• Study First Submitted: 2024-11-21
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-21
• Last Update Submitted: 2025-01-21
• Study First Posted: 2025-01-22
• Last Update Posted: 2025-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 88

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
• 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
• BP ≥160/110 mmHg
• Oophorectomy or amenorrhea > two years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes of symptom scores in Daily Dairy	from enrollment to the end of study at five weeks	To assess changes in symptom scores attained from product use in subjects with menopausal symptoms, including acute effects
Changes of symptom scores in Mobile Application	from enrollment to the end of study at five weeks	To assess changes in symptom scores attained from product use in subjects with menopausal symptoms, including acute effects

Secondary Outcome Measures

Name	Time	Method
Changes in Menopause-Specific Quality of Life (MENQOL) Scores	from enrollment to the end of study at five weeks	To assess changes in mood and quality of life scores of the product compared to placebo
Changes in Green Climacteric Scale (GCS) Scores	from enrollment to the end of study at five weeks	To assess changes in mood scores of the product compared to placebo
Changes in Perceived Stress Scale (PSS) Scores	from enrollment to the end of study at five weeks	To assess changes in mood scores of the product compared to placebo
Changes in Profile of Mood States (POMS) Scores	from enrollment to the end of study at five weeks	To assess changes in mood scores of the product compared to placebo
Changes in Pittsburgh Sleep Quality Index (PSQI) Scores	from enrollment to the end of study at five weeks	To assess changes in sleep scores of the product compared to placebo

Trial Locations

Locations (1)

See Final Report; 🇺🇸 San Francisco, California, United States