Examining an Oral Product for Menopausal Symptoms

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).

This study is testing a new dietary supplement to see if it can help healthy women with menopausal symptoms like hot flashes, stress, and sleep issues feel better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 44 (estimated)
• Ages: 40 Years to 65 Years
• Sex: Female
• Sponsor: Olly, PBC (industry)
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT06794021 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the efficacy of a dietary supplement containing a proprietary herbal extract blend and GABA in alleviating menopausal symptoms, particularly vasomotor symptoms like hot flashes. Participants will track their symptoms using a Daily Diary and a Mobile Application over a week, comparing results against a placebo. The study will also assess the product's impact on stress, anxiety, mood swings, and sleep quality through validated questionnaires. The trial is designed for healthy women experiencing significant menopausal symptoms.

Who should consider this trial

Good fit: Ideal candidates are healthy females aged 40 to 65 who experience significant menopausal symptoms, specifically more than five hot flashes per day.

Not a fit: Patients who are pregnant, breastfeeding, or currently on hormone replacement therapy will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new, effective treatment option for women suffering from menopausal symptoms.

How similar studies have performed: While there have been studies on herbal supplements for menopausal symptoms, the specific combination and approach in this trial may offer novel insights.

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.

Where this trial is running

San Francisco, California

• San Francisco Research Institute — San Francisco, California, United States (RECRUITING)

Conditions: Healthy, Menopause