Evaluating the effects of GABA on menopause symptoms
Official title: Valutazione Degli Effetti Benefici Di Un Prodotto Contenente Acido Γ-ammino Butirrico (GABA) Sui Disturbi Della Sindrome Climaterica CLIMATERICA
Run by Ospedale Policlinico San Martino · NCT06864520 · Data updated 2026-11-12
This study is testing if a GABA supplement can help menopausal women feel better by reducing symptoms like hot flashes, sleep problems, and mood swings.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | Women only |
| Enrollment | 112 (estimated) |
| Sponsor | Ospedale Policlinico San Martino Academic / other |
| Locations | 1 site (Genova, Italia) |
| Status | Recruiting |
| Started | October 25, 2023 |
| Main results expected | November 2025 |
| Study ends | December 2025 |
| Registry record updated | March 7, 2025 |
| Trial ID | NCT06864520 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women experiencing physiological or iatrogenic menopause with significant climacteric symptoms.
✕Probably not a fit
Patients currently using hormone replacement therapy or those with major psychiatric disorders may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to assess the effectiveness of a commercially available supplement containing Gamma-Aminobutyric Acid (GABA) in alleviating climacteric symptoms such as hot flashes, sleep disturbances, and mood swings in menopausal women. Participants will be randomly assigned to receive either the GABA supplement or a placebo for three months, with regular clinic visits to monitor their symptoms and overall well-being. The study will utilize various questionnaires and diaries to evaluate the intensity and frequency of symptoms throughout the trial period.
Why it matters
Potential benefit: If successful, this study could provide a non-hormonal treatment option for women experiencing menopausal symptoms.
How similar studies have gone: While the use of GABA for treating menopausal symptoms is relatively novel, other studies have explored similar non-hormonal approaches with varying degrees of success.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 * Glaucoma * Active liver disease * Use of antidepressants, benzodiazepines or any neuroactive drug * Known allergy to the components of the treatment being studied
Where it's running
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Ospedale San Martino
Genova, Italia, Italy Recruiting
Study contacts
- Principal investigator: Angelo Cagnacci, MD, PhD — Clinica Ostetrica e Ginecologica, IRCCS-Ospedale San Martino di Genova
- Study coordinator: Angelo Cagnacci
- Email: angelo.cagnacci@unige.it
- Phone: +39-010-3537728
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.