drugset / Trial / NCT06192641

Melatonin Use in Patients With Climacterious Symptoms in the Perimenopause

NCT06192641

RandomizedParallel-groupDouble-blindTreatment

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. During the perimenopause and menopause transition period, women may experience a variety of changes, including menstrual cycle irregularity and climacteric symptoms. Treatment to relieve symptoms may include hormonal and non-hormonal options, such as behavioral therapies, medications and low-dose hormonal therapies. The objective of this study will be to evaluate the effect of melatonin in women with perimenopausal symptoms. This is a double-blind, placebo-controlled randomized clinical trial research, where perimenopausal women will be interviewed, who will answer questionnaires, and will use melatonin/placebo for a period of 30 days, before and after, they will be asked about possible changes during treatment, such as mood changes, drowsiness, dizziness, headaches or allergic reactions. It is hoped that with this study, the effect of melatonin in women on climacteric symptoms during the perimenopausal period will be understood.

Timeline

Start
2023-10-20
Primary completion
2024-11-30
Completion
2024-12-20

Drugs

EvaluationDrugModalityDoseRoute
Comparator Melatonin Small molecule 3 mg Oral

Indications