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).

What this trial studies

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 in scope

• Healthy

Interventions

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

Who can join

Women only · Ages 40 Years to 65 Years · Accepts healthy volunteers.

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.

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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2025-07-07
• Primary completion: 2025-07-25
• Last update posted: 2025-07-16
• First posted: 2025-06-24

Sponsor & contact

Lead sponsor: Olly, PBC (Industry)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

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

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.