Melatonin Use in Patients With Climacterious Symptoms in the Perimenopause

Phase 2

Recruiting

• Conditions: Perimenopausal Disorder
• Interventions: Drug: Melatonin 3 MG

• Registration Number: NCT06192641
• Lead Sponsor: Univates

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.

Study Timeline

• Study Start: 2023-10-20
• Study First Submitted: 2023-12-19
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-04
• Last Update Submitted: 2024-01-04
• Study First Posted: 2024-01-05
• Last Update Posted: 2024-01-05
• Primary Completion: 2024-11-30
• Study Completion: 2025-02-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Melatonin	Melatonin 3 MG	Patients will receive 3 mg melatonin in capsule for 30 days. They will be instructed to ingest melatonin once a day, at night, one hour before bed.
Placebo	Melatonin 3 MG	Patients will receive placebo capsule composed of cellulose and indigestible fiber for 30 days. They will be instructed to ingest melatonin once a day, at night, one hour before bed.

Primary Outcome Measures

Name	Time	Method
Menopause rating scale	one month	Menopause scale, 0-44, higher score worse outcome

Secondary Outcome Measures

Name	Time	Method
Visual analogue scale of sleep	daily for one month	sleep scale, varies from worst possible (0) to best possible (10 cm)
Beck Depression Inventory II	one month	Level of depressive symptoms, 0-63, higher score worse outcome. Score 16 is considered depression.
Hamilton scale	one month	anxiety rating scale, 0-56, \>30 severe anxiety.
Visual Analog Pain Scale	daily for one month	pain scale, can vary from zero (no pain) to 100 mm (worst possible pain)
Pittsburgh Sleep Quality Index	one month	Sleep quality, 0-20, higher score worse sleep
Serum levels of S100β, TNF	after study	Elisa test, pg/ml
6-sulfatoximelatonin urine levels	after study	Elisa test, pg/ml

Trial Locations

Locations (1)

Gabriela Laste; 🇧🇷 Lajeado, Rio Grande Do Sul, Brazil