Status:
COMPLETED
Melatonin Use in Patients With Climacterious Symptoms in the Perimenopause
Lead Sponsor:
Univates
Collaborating Sponsors:
Aline Patrícia Brietzke
Ana Paula Costella
Conditions:
Perimenopausal Disorder
Eligibility:
FEMALE
45+ years
Phase:
PHASE2
Brief Summary
Menopause is defined as the absence of menstruation for 12 months without a pathological cause and it is marked by physical fluctuations and biological changes that can impact women's quality of life....
Detailed Description
This is a randomized, double-blind, parallel, placebo-controlled clinical trial. 40 patients will be recruited to participate in the study, 20 of whom will receive the treatment and 20 will receive th...
Eligibility Criteria
Inclusion
- Being female and in peri-menopause, experiencing an irregular menstrual cycle, having had at least one menstrual period in the last 6 months.
- Age 45 years or older
- Be literate
Exclusion
- History of alcohol or other substance abuse in the last 6 months
- Use of hormonal therapy;
- Neurological disease;
- Oncological disease;
- Ischemic heart disease;
- Liver failure;
- Renal insufficiency;
- Use of central nervous system medications (antidepressants, anticonvulsants, antipsychotics and benzodiazepines)
Key Trial Info
Start Date :
October 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06192641
Start Date
October 20 2023
End Date
December 20 2024
Last Update
November 13 2025
Active Locations (1)
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1
Gabriela Laste
Lajeado, Rio Grande do Sul, Brazil, 95900-000