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Recruiting

NCT Number: NCT07033013

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).

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

Recruiting

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Key information

Conditions

Age range

40 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

San Francisco Research Institute

San Francisco, California, 94132, United States

Location status: Recruiting

Location contact

John Ademola

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Dietary Supplement

Placebo

Dietary Supplement with actives

Dietary Supplement

Dietary supplement containing EstroG-100 and GABA

Primary outcomes

  1. 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)

    To assess the efficacy for improvement of a treatment product on menopausal vasomotor symptoms (hot flashes- intensity, duration) within 24 hours compared to placebo through daily diary data and MenoLife application based diary.

Secondary outcomes

  1. Improvement of overall daily menopausal vasomotor symptoms

    Time frame: from enrollment to end of study at Day 15

    To assess the efficacy for improvement of overall daily menopausal vasomotor symptoms compared to placebo through daily diary data and MenoLife diary though 7 days. Data in the Daily diary and MenoLife Diary will be compared between the active supplement and placebo groups across different time points.

Other outcomes

  1. Assess Menopause symptoms using the Greene Climacteric Scale (GCS).

    Time frame: from enrollment to end of study at Day 15

    To assess the efficacy of the investigation product on menopause symptoms using a validated questionnaire Greene Climacteric Scale (GCS). Data from the GCS Score will be compared between the active supplement and placebo groups across different time points.

Sponsors and collaborators

Lead sponsor

Olly, PBC

Industry

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 24, 2025
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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