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Study of an Oral Product for Menopausal Symptoms

This study is testing an oral dietary supplement containing EstroG-100 and GABA to see if it helps with menopausal symptoms, especially hot flashes. Researchers will compare it to a placebo (an inactive substance). You might be able to join if you are a healthy woman between 40 and 65 years old, experience more than 5 hot flashes a day, have had these symptoms for at least two months, and have a normal body mass index (BMI). The main goal is to see how the supplement affects hot flashes within 24 hours after a single dose. The current recruitment status is unclear, and the study plans to enroll 40 participants.

Study design
This is a randomized, double-blind, placebo-controlled study, meaning participants are randomly assigned to receive either the active supplement or a placebo, and neither you nor the researchers will know which you are receiving. It involves about 40 participants.
What's involved
You would keep a daily diary log and complete questionnaires. The study includes a baseline period before treatment starts.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome measures effects on hot flashes within 24 hours after a single dose, from Day 7 to Day 8 of the study.

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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).

Recruiting
NAAges 40–65InterventionalSupportive care
Olly, PBC
~40 participants
Updated 2025-07-16 on ClinicalTrials.gov
What's tested:PlaceboDietary Supplement with actives

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
24 hour effects following single dose of Mellow Menopause - Hot Flashes
Measured over From baseline Day 7 to Treatement Day 1 (Day 8 of study)

Conditions

Healthy

Explore related trials

Menopause present

Where it's being run

1 sites across 1 states
California1

Who to contact

John Ademola
[email protected]
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • 24 hour effects following single dose of Mellow Menopause - Hot FlashesFrom 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.