Evaluating the effects of GABA on menopause symptoms
Valutazione Degli Effetti Benefici Di Un Prodotto Contenente Acido Γ-ammino Butirrico (GABA) Sui Disturbi Della Sindrome Climaterica CLIMATERICA
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 112 (estimated) |
| Sex | Female |
| Sponsor | Ospedale Policlinico San Martino Academic / other |
| Locations | 1 site (Genova, Italia) |
| Trial ID | NCT06864520 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women experiencing physiological or iatrogenic menopause with significant climacteric symptoms.
Not a fit: Patients currently using hormone replacement therapy or those with major psychiatric disorders may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Genova, Italia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.