Melatonin Use in Patients With Climacterious Symptoms in the Perimenopause

Perimenopausal Disorder Clinical Trial

Official title:

Benefits of Melatonin Use in Patients With Climacterious Symptoms in the Perimenopause: Randomized, Double-blind, Placebo-controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06192641
• Other study ID #: 10901364
• Status: Recruiting
• Phase: Phase 2
• Start date: October 20, 2023
• Est. completion date: February 20, 2025

Study information

• Verified date: January 2024
• Source: Univates
• Contact: Gabriela Laste, Ph.D
• Phone: 55517147000
• Email: gabrielalaste[@]univates.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 20, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Perimenopausal Disorder

Intervention

Drug:
• Melatonin 3 MG
patients received 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).

Locations

Country	Name	City	State
Brazil	Gabriela Laste	Lajeado	Rio Grande Do Sul

Sponsors (3)

Lead Sponsor	Collaborator
Univates	Aline Patrícia Brietzke, Ana Paula Costella

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Menopause rating scale	Menopause scale, 0-44, higher score worse outcome	one month
Secondary	Beck Depression Inventory II	Level of depressive symptoms, 0-63, higher score worse outcome. Score 16 is considered depression.	one month
Secondary	Pittsburgh Sleep Quality Index	Sleep quality, 0-20, higher score worse sleep	one month
Secondary	Serum levels of S100ß, TNF	Elisa test, pg/ml	after study
Secondary	6-sulfatoximelatonin urine levels	Elisa test, pg/ml	after study
Secondary	Visual Analog Pain Scale	pain scale, can vary from zero (no pain) to 100 mm (worst possible pain)	daily for one month
Secondary	Hamilton scale	anxiety rating scale, 0-56, >30 severe anxiety.	one month
Secondary	Visual analogue scale of sleep	sleep scale, varies from worst possible (0) to best possible (10 cm)	daily for one month