Actively Recruiting

Phase Not Applicable
Age: 40Years - 65Years
FEMALE
Healthy Volunteers
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).

Led by Olly, PBC · Updated on 2025-07-16

40

Participants Needed

1

Research Sites

3 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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).

Who Can Participate

Age: 40Years - 65Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy females aged 40 to 65 years
  • Experience more than 5 hot flashes per day for at least 60 days before the baseline visit
  • Report variable menstrual cycle length greater than 7 days different from normal
  • Have a normal body mass index (BMI) under 30 kg/m2
  • Able to read, understand, and complete study questionnaires and records
  • Able to understand study procedures
  • Able to comply with all study requirements
  • Provide written informed consent to participate
  • Willing to actively participate and attend scheduled visits
Not Eligible

You will not qualify if you...

  • Pregnancy or breastfeeding
  • Immune insufficiency
  • Women of childbearing potential who are still having regular menstrual cycles and are not perimenopausal, menopausal, or post-menopausal
  • History of hysterectomy
  • Currently on hormone replacement therapy
  • Use of systemic corticosteroids or immunosuppressant drugs
  • Diseases or medications that could interfere with the study or risk participant health, including thyroid disease, diabetes, hormone-dependent gynecological cancer, endometrial hyperplasia, uterine or endometrial cancer, drug and alcohol abuse, mental disorders, abnormal kidney or liver function, personal or family history of breast cancer in a first-degree relative, and clotting disorders such as deep vein thrombosis
  • Cardiovascular, chronic liver, thyroid, or kidney diseases
  • History of cancer
  • Any condition affecting 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 after 10 minutes seated rest)
  • Oophorectomy or amenorrhea for more than two years
  • Participation in another clinical trial within one month before or during this study
  • Continuous intake of certain herbal foods within the past month
  • Employment by the institute, brand owner, or product manufacturers
  • Habitual medicine and supplement intake will be recorded prior to inclusion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

San Francisco Research Institute

San Francisco, California, United States, 94132

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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