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).

NCT07033013 | Recruiting

• 1 other identifier: UNLV20250320
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Healthy

Outcome Measures

Primary Outcomes (1)

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

  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.

  From baseline Day 7 to Treatement Day 1 (Day 8 of study)

Secondary Outcomes (1)

• Improvement of overall daily menopausal vasomotor symptoms

  from enrollment to end of study at Day 15

Other Outcomes (1)

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

  from enrollment to end of study at Day 15

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Instructions: Take 1 capsule when having a hot flash at the onset of a hot flash (not to exceed 1 capsule/day). Only treat 1 hot flash during a 24-hour period.

Dietary Supplement: Placebo

Dietary Supplement with actives

ACTIVE COMPARATOR

Instructions: Take 1 capsule when having a hot flash at the onset of a hot flash (not to exceed 1 capsule/day). Only treat 1 hot flash during a 24-hour period.

Dietary Supplement: Dietary Supplement with actives

Interventions

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Dietary Supplement with actives DIETARY_SUPPLEMENT

Dietary supplement containing EstroG-100 and GABA

Dietary Supplement with actives

Eligibility Criteria

• Age: 40 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Olly, PBC: lead

Study Sites (1)

San Francisco Research Institute

San Francisco, California, 94132, United States

RECRUITING

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: June 24, 2025
• Study Start: July 7, 2025
• Primary Completion: July 25, 2025
• Study Completion: August 1, 2025
• Last Updated: July 16, 2025

Record last verified: 2025-07

Locations

US (1)