A Randomized, Double Blind, Placebo Controlled, Clinical Study to Examine the Benefits of an Oral Product in Panelists With Menopausal Symptoms Including Vasomotor Symptoms (VMS).

Overview

Randomized, Double-Blind, Placebo-Controlled, Single-Center Clinical Study with a Run-in Baseline, Daily Diary Log, and Validated Questionnaires (Greene GCS) with Oral Dietary Supplement

Interventions

• Dietary supplement Placebo
  Placebo
• Dietary supplement Dietary Supplement with actives
  Dietary supplement containing EstroG-100 and GABA

Primary outcome measures

• 24 hour effects following single dose of Mellow Menopause - Hot Flashes [Time frame: From baseline Day 7 to Treatement Day 1 (Day 8 of study)]

Secondary outcome measures (1)

• Improvement of overall daily menopausal vasomotor symptoms [Time frame: from enrollment to end of study at Day 15]

Eligibility criteria

Inclusion criteria

• Healthy Females aged 40 to 65 years
• Self-reporting menopausal symptoms (> 5 hot flashes 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
• NORMAL BMI (per metropolitan life tables): under 30 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 panelist's health under risk, such as: thyroid disease, diabetes mellitus, history of hormone dependent (gynecological) cancer, endometrial hyperplasia, uterine cancer, endometrial cancer, drug and alcohol abuse, mental disorder, abnormality in renal and liver functions, personal or family history of breast cancer in a first degree relative, and history of clotting disorder such as deep vein thrombosis.)
• 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 or drugs
• Uncontrolled hypertension (160/100 mmHg or higher, measured after 10 min of seated rest)
• Oophorectomy or amenorrhea > two years.
• Participating in a different clinical trial within one month of the start of this clinical trial or planning to participate in another clinical trial during the trial period
• Continuous intake of foods based on Cynanchum wilfordii Hemsley, Phlomis umbrosa Turczaninow, and Angelica gigas Nakai within the past month
• Employees of the institute or the brand owner or the manufacturers of the product
• Note: Habitual medicine and supplement intake will be registered prior to inclusion in the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Supportive care

Study locations

United States · 1 center

• San Francisco Research Institute — San Francisco

Identifiers

NCT: NCT07033013 · UNLV20250320

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗