Clinical trial NCT06794021: One Week Clinical Study in Subjects With Menopausal Symptoms
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).
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Menopause
Lead sponsor: Olly, PBC
Sponsor class: INDUSTRY
First posted: 2025-01-27
Enrollment: 44
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 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)


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 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.

Primary outcomes:
measure: Daily Diary - 24hr
timeFrame: from enrollment to the end of study at seven days
measure: Mobile App - 24hr
timeFrame: from enrollment to the end of study at seven days
Secondary outcomes:
measure: Daily Dairy - Days 1-6
timeFrame: from enrollment to the end of study at seven days
measure: Mobile App - Days 1-6
timeFrame: from enrollment to the end of study at seven days
measure: Green Climacteric Scale (GCS) - Days 1-6
timeFrame: from enrollment to the end of study at seven days
measure: Menopause-Specific Quality of Life (MENQOL) - Days 1-6
timeFrame: from enrollment to the end of study at seven days
Other outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI) - Day 7
timeFrame: from enrollment to the end of study at seven days
measure: Perceived Stress Scale (PSS) - Day 7
timeFrame: from enrollment to the end of study at seven days
measure: Profile of Mood States questionnaire (POMS) - Day 7
timeFrame: from enrollment to the end of study at seven days
Locations:
city: San Francisco
country: United States
facility: San Francisco Research Institute
state: California
Study officials:
References: