NCT06864520 Evaluation of the Beneficial Effects of a Product Containing Γ-aminobutyric Acid (GABA) on Climacteric Syndrome Disorders
| NCT ID | NCT06864520 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ospedale Policlinico San Martino |
| Condition | Climacteric Symptoms |
| Study Type | INTERVENTIONAL |
| Enrollment | 112 participants |
| Start Date | 2023-10-25 |
| Primary Completion | 2025-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 112 participants in total. It began in 2023-10-25 with a primary completion date of 2025-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. No important side effects are reported. Researchers will compare supplement based on GABA to a placebo (a look-alike substance that contains no active ingredients) to see if supplement based on GABA works to treat climateric symptoms. Participants will: * Take supplement based on GABA or a placebo every day for 3 months * Visit the clinic on day 7, 37 and 97 after enrolment for checkups and tests * Keep a diary of number and intensity of hot flashes * To fill scales evaluating sleep quality, anxiety, depression and quality of life
Eligibility 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
Contact & Investigator
Angelo Cagnacci, MD, PhD
PRINCIPAL INVESTIGATOR
Clinica Ostetrica e Ginecologica, IRCCS-Ospedale San Martino di Genova
Frequently Asked Questions
Who can join the NCT06864520 clinical trial?
This trial is open to female participants only, studying Climacteric Symptoms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06864520 currently recruiting?
Yes, NCT06864520 is actively recruiting participants. Contact the research team at angelo.cagnacci@unige.it for enrollment information.
Where is the NCT06864520 trial being conducted?
This trial is being conducted at Genova, Italy.
Who is sponsoring the NCT06864520 clinical trial?
NCT06864520 is sponsored by Ospedale Policlinico San Martino. The principal investigator is Angelo Cagnacci, MD, PhD at Clinica Ostetrica e Ginecologica, IRCCS-Ospedale San Martino di Genova. The trial plans to enroll 112 participants.