Clinical trial NCT06787443: Randomized Placebo Controlled Clinical Study of an Oral Product in Subjects With Menopausal Symptoms
Official title: A Randomized, Placebo Controlled Clinical Study to Examine the Clinical Benefits of an Oral Product in Subjects With Menopausal Symptoms Including Vasomotor Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopausal Symptoms
Lead sponsor: Olly, PBC
Sponsor class: INDUSTRY
First posted: 2025-01-22
Enrollment: 88
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes of symptom scores in Daily Dairy
timeFrame: from enrollment to the end of study at five weeks
measure: Changes of symptom scores in Mobile Application
timeFrame: from enrollment to the end of study at five weeks
Secondary outcomes:
measure: Changes in Menopause-Specific Quality of Life (MENQOL) Scores
timeFrame: from enrollment to the end of study at five weeks
measure: Changes in Green Climacteric Scale (GCS) Scores
timeFrame: from enrollment to the end of study at five weeks
measure: Changes in Perceived Stress Scale (PSS) Scores
timeFrame: from enrollment to the end of study at five weeks
measure: Changes in Profile of Mood States (POMS) Scores
timeFrame: from enrollment to the end of study at five weeks
measure: Changes in Pittsburgh Sleep Quality Index (PSQI) Scores
timeFrame: from enrollment to the end of study at five weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: See Final Report
state: California
Study officials:
References: