Melatonin Use in Patients With Climacterious Symptoms in the Perimenopause

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

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.

Study Overview

• Status: Recruiting
• Conditions: Perimenopausal Disorder
• Intervention / Treatment: Drug: Melatonin 3 MG

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Gabriela Laste, Ph.D; Phone Number: 55517147000; Email: gabrielalaste@univates.br

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Lajeado, Rio Grande Do Sul, Brazil, 95900-000
      • Recruiting
      • Gabriela Laste
      • Contact: Gabriela Laste, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Melatonin; 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.	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).; Other Names: melatonin
Placebo Comparator: Placebo; 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.	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).; Other Names: melatonin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Menopause rating scale	Menopause scale, 0-44, higher score worse outcome	one month

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Univates
• Collaborators: Aline Patrícia Brietzke; Ana Paula Costella

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2023
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): February 20, 2025

Study Registration Dates

• First Submitted: December 19, 2023
• First Submitted That Met QC Criteria: January 4, 2024
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Antioxidants; Melatonin
• Other Study ID Numbers: 10901364

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes