Climacteric SymptomsGABAPAUSENCT06864520
Evaluation of the Beneficial Effects of a Product Containing Γ-aminobutyric Acid (GABA) on Climacteric Syndrome Disorders
A study testing GAMMA-AMINOBUTYRIC ACID - GABA in people with Climacteric Symptoms and Hot Flashes, run by Ospedale Policlinico San Martino at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Climacteric Symptoms, Hot Flashes
- What is being tested?
- GAMMA-AMINOBUTYRIC ACID - GABA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteItaly
- Study dates
- 25 Oct 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Physiological or iatrogenic menopause (amenorrhea for at least 12 months or for 6 months with FSH ≥40 IU/L)
- Greene Index value ≥ 15
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Ospedale San Martino
Genova, Italia, 16132
ANGELO CAGNACCI, +39 - 010 - 3537728, angelo.cagnacci@unige.it
About this study
Official title: Valutazione Degli Effetti Benefici Di Un Prodotto Contenente Acido Γ-ammino Butirrico (GABA) Sui Disturbi Della Sindrome Climaterica CLIMATERICA
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.
Read more
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
Read the detailed description
This study aims to evaluate the effectiveness of a commercial supplement to alleviate symptoms associated with menopause such as hot flashes, sleep disturbances, and mood swings.
Participants will be required to come to the clinic for a few visits:
- First visit in which the nature of the study will be explained, the intensity of symptoms will be assessed (using the Greene questionnaire), and the inclusion and exclusion criteria for participation in the study will be assessed. If the participant is eligible for the study, they will be asked to fill out a diary for the next 7 days in which to indicate the daily number and intensity of hot flashes;
- Second visit in which the hot flash diary will be collected and the following questionnaires will be submitted: Greene Scale to determine climacteric symptoms; STAI-Y1 to determine state anxiety (20 questions); SDS to determine the presence of depression (20 questions); PSQI to determine the quality of sleep (9 questions); MenQoL, Quality of life (29 questions). At this visit, a new diary will be provided, in which the number and intensity of hot flashes during the last 7 days before the next visit must be reported, and the product to be taken for the following month will be provided; neither the participant nor the investigator are aware of the product provided: study product or placebo;
- Third visit, in which the hot flash diary and the product package delivered at the previous visit will be collected. The participant will have to fill in all the questionnaires completed at the previous visit and will also be asked about the degree of satisfaction with the first 30 days of treatment. At this visit, a new diary will be provided, in which the number and intensity of hot flashes during the last 7 days before the next visit must be reported, and the product to be taken for the following two months will be provided;
- Fourth visit, in which the hot flash diary and the product package delivered at the previous visit will be collected. The participant will have to fill out all the questionnaires completed at the previous visit and will also be asked about the degree of satisfaction with the treatment.
- Conditions
- Climacteric Symptoms, Hot Flashes
- Being tested
- GAMMA-AMINOBUTYRIC ACID - GABA, Placebo
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GAMMA-AMINOBUTYRIC ACID - GABADietary supplement
Food supplement based on GABA and Melissa extract
PlaceboOther
Placebo based on microcrystalline cellulose, rice bran, bitter cocoa powder
| Study group | Role | What they receive |
|---|---|---|
| Group A1 with 3 capsules | Active comparator | Tablets containing 250mg of γ-aminobutyric acid (GABA) and 50mg of Melissa extract, to be taken one at lunch and two before bedtime for 12 weeks Receives: Dietary Supplement: GAMMA-AMINOBUTYRIC ACID - GABA |
| Group A2 with 3 capsules | Placebo comparator | Tablets containing microcrystalline cellulose, rice bran, bitter cocoa powder, to be taken one at lunch and two before bedtime for 12 weeks Receives: Other: Placebo |
| Group B1 with 2 capsules | Active comparator | Tablets containing 250mg of γ-aminobutyric acid (GABA) and 50mg of Melissa extract, to be taken one at lunch and one before bedtime for 12 weeks Receives: Dietary Supplement: GAMMA-AMINOBUTYRIC ACID - GABA |
| Group B2 with 2 capsules | Placebo comparator | Tablets containing microcrystalline cellulose, rice bran, bitter cocoa powder, to be taken one at lunch and one before bedtime for 12 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the Greene Climacteric Scale Score
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 from 0 to 63, higher values corresponding to more intense climacteric symptoms. A value equal or greater than 15 indicates the presence of climacteric symptoms
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (5)
Assessment of anxiety with the State-Trait Anxiety Inventory-Y1 (STAI-Y1) questionnaire
The State-Trait Anxiety Inventory (STAI) is a commonly used measure of state (Y1) of anxiety with 20 items. It can be used to diagnose anxiety and to distinguish it from depressive syndromes. All items are rated on a 4-point scale (with 1 = not at all and 4 = very much) and the total score is between 20 and 80 with a threshold value predictive of anxious symptoms set at 40. Higher scores are positively correlated with higher levels of anxiety
Measured: From enrollment to the end of treatment at 12 weeks
Assessment of sleep quality with the Pittsburgh Sleep Quality Index (PSQI) questionnaire
The Pittsburgh Sleep Quality Index assesses sleep quality and disturbances. The global score ranges between 0 and 21, where higher scores indicate worse sleep quality
Measured: From enrollment to the end of treatment at 12 weeks
Reduction in the number and intensity of hot flashes, assessed with a daily diary 7 days before follow up
Participants report in their daily diary the number and intensity of hot flashes, rating them on a 3-point scale (1 = mild, 2 = moderate, and 3 = severe).
Measured: From enrollment to the end of treatment at 12 weeks
Assessment of quality of life with the Menopause-specific Quality of Life (MenQoL) questionnaire
The MENQOL consists of a total of 29 items in a Likert-scale format. Each item assesses the impact of one of four domains of menopausal symptoms: vasomotor, psychosocial, physical, and sexual. Items pertaining to a specific symptom are rated as present or not present, and if present, how bothersome on a zero (not bothersome) to six (extremely bothersome) scale. The possible score on any item ranges from one to eight, where higher score indicates higher symptoms
Measured: From enrollment to the end of treatment at 12 weeks
Comparison of the efficacy of two dosages
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start25 Oct 2023
- Primary completionNov 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Climacteric SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale Policlinico San Martino
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angelo Cagnacci, Ospedale Policlinico San Martino
- Investigators
- Angelo Cagnacci, MD, PhD, Principal investigator, Clinica Ostetrica e Ginecologica, IRCCS-Ospedale San Martino di Genova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06864520
- Sponsor's protocol ID
- 12420
- Acronym
- GABAPAUSE
- Status last verified
- Feb 2025
- First submitted
- 24 Feb 2025
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valutazione Degli Effetti Benefici Di Un Prodotto Contenente Acido Γ-ammino Butirrico (GABA) Sui Disturbi Della Sindrome Climaterica CLIMATERICA
- ClinicalTrials.gov ID
- NCT06864520
- Acronym / sponsor ID
- GABAPAUSE / 12420
- Conditions
- Climacteric Symptoms, Hot Flashes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Ospedale Policlinico San MartinoUniversity, hospital or other
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 7 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This study aims to evaluate the effectiveness of a commercial supplement to alleviate symptoms associated with menopause such as hot flashes, sleep disturbances, and mood swings.
Participants will be required to come to the clinic for a few visits:
- First visit in which the nature of the study will be explained, the intensity of symptoms will be assessed (using the Greene questionnaire), and the inclusion and exclusion criteria for participation in the study will be assessed. If the participant is eligible for the study, they will be asked to fill out a diary for the next 7 days in which to indicate the daily number and intensity of hot flashes;
- Second visit in which the hot flash diary will be collected and the following questionnaires will be submitted: Greene Scale to determine climacteric symptoms; STAI-Y1 to determine state anxiety (20 questions); SDS to determine the presence of depression (20 questions); PSQI to determine the quality of sleep (9 questions); MenQoL, Quality of life (29 questions). At this visit, a new diary will be provided, in which the number and intensity of hot flashes during the last 7 days before the next visit must be reported, and the product to be taken for the following month will be provided; neither the participant nor the investigator are aware of the product provided: study product or placebo;
- Third visit, in which the hot flash diary and the product package delivered at the previous visit will be collected. The participant will have to fill in all the questionnaires completed at the previous visit and will also be asked about the degree of satisfaction with the first 30 days of treatment. At this visit, a new diary will be provided, in which the number and intensity of hot flashes during the last 7 days before the next visit must be reported, and the product to be taken for the following two months will be provided;
- Fourth visit, in which the hot flash diary and the product package delivered at the previous visit will be collected. The participant will have to fill out all the questionnaires completed at the previous visit and will also be asked about the degree of satisfaction with the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A1 with 3 capsules | Active comparator | Dietary Supplement: GAMMA-AMINOBUTYRIC ACID - GABATablets containing 250mg of γ-aminobutyric acid (GABA) and 50mg of Melissa extract, to be taken one at lunch and two before bedtime for 12 weeks |
| Group A2 with 3 capsules | Placebo comparator | Other: PlaceboTablets containing microcrystalline cellulose, rice bran, bitter cocoa powder, to be taken one at lunch and two before bedtime for 12 weeks |
| Group B1 with 2 capsules | Active comparator | Dietary Supplement: GAMMA-AMINOBUTYRIC ACID - GABATablets containing 250mg of γ-aminobutyric acid (GABA) and 50mg of Melissa extract, to be taken one at lunch and one before bedtime for 12 weeks |
| Group B2 with 2 capsules | Placebo comparator | Other: PlaceboTablets containing microcrystalline cellulose, rice bran, bitter cocoa powder, to be taken one at lunch and one before bedtime for 12 weeks |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Physiological or iatrogenic menopause (amenorrhea for at least 12 months or for 6 months with FSH ≥40 IU/L)
- Greene Index value ≥ 15
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GAMMA-AMINOBUTYRIC ACID - GABAFood supplement based on GABA and Melissa extract | Dietary supplement | Group A1 with 3 capsules, Group B1 with 2 capsules |
| PlaceboPlacebo based on microcrystalline cellulose, rice bran, bitter cocoa powder | Other | Group A2 with 3 capsules, Group B2 with 2 capsules |
Primary outcome
Change of the Greene Climacteric Scale Score
Time frame: 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 from 0 to 63, higher values corresponding to more intense climacteric symptoms. A value equal or greater than 15 indicates the presence of climacteric symptoms
5 secondary outcomes
Assessment of anxiety with the State-Trait Anxiety Inventory-Y1 (STAI-Y1) questionnaire
Time frame: From enrollment to the end of treatment at 12 weeks
Assessment of sleep quality with the Pittsburgh Sleep Quality Index (PSQI) questionnaire
Time frame: From enrollment to the end of treatment at 12 weeks
Reduction in the number and intensity of hot flashes, assessed with a daily diary 7 days before follow up
Time frame: From enrollment to the end of treatment at 12 weeks
Assessment of quality of life with the Menopause-specific Quality of Life (MenQoL) questionnaire
Time frame: From enrollment to the end of treatment at 12 weeks
Comparison of the efficacy of two dosages
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Angelo Cagnacci, MD, PhD principal investigator
Clinica Ostetrica e Ginecologica, IRCCS-Ospedale San Martino di Genova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GAMMA-AMINOBUTYRIC ACID - GABA in people with Climacteric Symptoms and Hot Flashes, run by Ospedale Policlinico San Martino at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ANGELO CAGNACCI (+39-010-3537728, angelo.cagnacci@unige.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the Greene Climacteric Scale Score (time frame: From enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.