Clinical trial NCT06192641: Melatonin Use in Patients With Climacterious Symptoms in the Perimenopause
Official title: Benefits of Melatonin Use in Patients With Climacterious Symptoms in the Perimenopause: Randomized, Double-blind, Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Perimenopausal Disorder
Lead sponsor: Univates
Sponsor class: OTHER
Collaborators: name: Aline Patrícia Brietzke
name: Ana Paula Costella
First posted: 2024-01-05
Enrollment: 40
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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 the placebo.Patients will receive 3 mg melatonin in capsule or placebo (capsule identical to the treatment, both in color, taste, odor and shape, composed of cellulose and indigestible fiber) (PALMER, 2020). (GOLTZMAN, 2021) for 30 days (Treister-Goltzman; Peleg, 2021) They will be instructed to ingest melatonin once a day, at night, one hour before bed (PALMER, et al. 2020).
Primary purpose: TREATMENT

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. 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 have samples of blood and urine collected, which will be measured and stored in the Univates laboratory. They will also 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.

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 the placebo for a period of 30 days.Before and after, they will have samples of blood and urine collected, which will be measured and stored in the Univates laboratory. They will also be asked about possible changes during treatment, such as mood changes, drowsiness, dizziness, headaches or allergic reactions.

The study will be carried out at the São Cristóvão Basic Health Unit in Lajeado - RS. The research and invitation to participate will also be publicized through the University of Vale do Taquari's social media, through an informative/explanatory text. Data collection from these participants will be carried out at their homes or in a location that suits them best by arrangement. If the participant has travel expenses for their participation, travel/transportation costs will be reimbursed within the project budget, which will be the responsibility of the responsible researcher.

The study protocol was submitted and approved by the Univates Health Research Ethics Committee by CAAE: 70400923.9.0000.5310 and opinion no.: 6.131.475.

For statistical analyzes the statistical program JAMOVI (Version 2.3) \[Computer Software\] (2022) and R Core Team (2021) will be used. The Kolmogorov Smirnov and Shapiro-Wilk Test will be used to verify the normality of the data. Non-parametric samples will be analyzed using the Mann-Whitney U test and parametric t-test. Continuous variables will be presented as mean±SD. The number and percentage will be presented as n (%), and numerical data will be analyzed using the Chi-square test (χ²) and/or Fisher's exact test. The Confidence Interval value (IC95%) will be provided. The value of p\<0.05 will be considered statistically significant.

Eligibility criteria: Inclusion Criteria:- 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 Criteria:-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)

Primary outcomes:
measure: Menopause rating scale
timeFrame: one month
Secondary outcomes:
measure: Beck Depression Inventory II
timeFrame: one month
measure: Pittsburgh Sleep Quality Index
timeFrame: one month
measure: Serum levels of S100β, TNF
timeFrame: after study
measure: 6-sulfatoximelatonin urine levels
timeFrame: after study
measure: Visual Analog Pain Scale
timeFrame: daily for one month
measure: Hamilton scale
timeFrame: one month
measure: Visual analogue scale of sleep
timeFrame: daily for one month
Other outcomes:
Locations:
city: Lajeado
country: Brazil
facility: Gabriela Laste
state: Rio Grande Do Sul
Study officials:
References: