Evaluation of the Beneficial Effects of a Product Containing Γ-aminobutyric Acid (GABA) on Climacteric Syndrome Disorders

What this trial studies

The goal of this clinical trial is to learn if the food supplement based on GABA works to treat climateric symptoms. It will also learn about the safety of supplement based on GABA. The main question aims to answer: * Does food supplement based on GABA lower the climateric symptoms, such as hot flashes, sleep, disturbances, mood swings? * The supplement that will be administered is commonly available on the market and can be used without particular precautions.

Conditions in scope

• Climacteric Symptoms
• Hot Flashes

Interventions

• GAMMA-AMINOBUTYRIC ACID - GABA (Dietary Supplement) — Food supplement based on GABA and Melissa extract
• Placebo (Other) — Placebo based on microcrystalline cellulose, rice bran, bitter cocoa powder

Who can join

Women only · Adults (Child, Adult, Older Adult)

Inclusion criteria

• Physiological or iatrogenic menopause (amenorrhea for at least 12 months or for 6 months with FSH ≥40 IU/L)
• Greene Index value ≥ 15

Exclusion criteria

• Patients who do not consent to the study
• Patients who have used hormone replacement therapy in the last 3 months
• Patients who have used phytotherapeutics in the last 3 months
• Patients who have used acupuncture in the last 3 months
• Uncompensated hyper or hypothyroidism
• Acute phase of endocrine pathologies
• Patients with major psychiatric disorders
• Addiction to opioids or alcohol

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: 2023-10-25
• Primary completion: 2025-11
• Last update posted: 2025-03-07
• First posted: 2025-03-07

Sponsor & contact

Lead sponsor: Ospedale Policlinico San Martino (Other)

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

• Change of the Greene Climacteric Scale Score (From enrollment to the end of treatment at 12 weeks)
  The Greene Scale is a verified measurement tool which provides a brief measure of menopause symptoms. It is composed of 21 items evaluating the bother of climacteric symptoms with a score for each symptom from none (value of 0) to mild (value of 1) to moderate (value of 2) to intense (value of 3). The total score of the ranges…

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.