Status:
COMPLETED
The Effect of a Multivitamin in the Treatment of Memory Loss in Postmenopausal Women
Lead Sponsor:
Eurofarma Laboratorios S.A.
Conditions:
Memory Disorders
Postmenopausal Symptoms
Eligibility:
FEMALE
45-60 years
Phase:
NA
Brief Summary
Complaints about memory loss are very common in women in the menopausal transition period. The effectiveness of estrogen replacement therapy in cognitive improvement is controversial. Partial positive...
Detailed Description
This multicenter, non-comparative phase IV clinical trial will be conducted at brazilian clinical trial centers under the auspices of Eurofarma Laboratories S.A. Recruitment for the study will begin a...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Age ≥ 45 years and ≤ 60 years.
- Memory loss associated with menopause.
- Score ≤ 3.0 (mean value found in the elderly) related to the self-efficacy factor, consisting of the sum of the scores for the Capability, Control and Change domains obtained through the Metamemory in Adulthood Questionnaire - reduced version (MIAr).
- Amenorrhea for at least 1 year and there is no more than 6 years.
- Serum FSH dosage\> 30mIU / mL.
- Dosage of serum estradiol \<20pg / mL.
- Knowledge of the Portuguese language sufficient to answer the questionnaires.
- Signature of the Free and Informed Consent Form (EHIC) prior to any study procedure.
- Exclusion criteria:
- Individuals who meet at least one of the following criteria will be excluded from the study:
- Complaints of hot flashes, insomnia and / or very intense sleep disorders, at the discretion of the investigator.
- Presence of moderate to severe depression, score ≥ 18 at assessment through the Beck Depression Inventory. ,
- Presence of moderate to severe anxiety, with a ≥ 30 score on the Beck anxiety inventory. ,
- Initiation of hormone replacement therapy in the 6 months prior to study inclusion. Patients receiving hormone replacement therapy starting more than 6 months before inclusion in the study may be included in the study provided that the treatment is regular with the same drug and the same dose during the last 6 months before inclusion and provided that this treatment is maintained throughout the study.
- Use of psychotropic medications (anticonvulsants, benzodiazepines, antipsychotics), selective serotonin reuptake inhibitors (SSRIs) and selective serotonin and noradrenaline reuptake inhibitors (SSRIs)
- Alcoholism and / or use of other illicit drugs.
- History of allergy or intolerance to any component of the experimental product formulation.
- Diagnosis of neurological diseases associated with cognitive deficits (including dementia and mental retardation) or psychiatric illnesses.
- Presence of serious or uncontrolled diseases (such as decompensated hypothyroidism) at the discretion of the researcher (such as stroke, Parkinson's disease, etc.).
- Participation in clinical research protocol in the previous 12 months unless, at the discretion of the researcher, their participation in the study may incur direct benefit to the research participant.
- Presence of any condition that, at the discretion of the researcher, makes the patient unfit to participate in the study.
Exclusion
Key Trial Info
Start Date :
January 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2019
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03835325
Start Date
January 23 2019
End Date
November 30 2019
Last Update
April 15 2025
Active Locations (1)
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1
CEPIC
São Paulo, São Paulo, Brazil