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Melatonin Use in Patients With Climacterious Symptoms in the Perimenopause

NCT06192641 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-11-13

No results posted yet for this study

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.

Conditions

  • Perimenopausal Disorder

Interventions

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).

Sponsors & Collaborators

  • Aline Patrícia Brietzke

    collaborator UNKNOWN

  • Ana Paula Costella

    collaborator UNKNOWN

  • Univates

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-20
Primary Completion
2024-11-30
Completion
2024-12-20
FDA Drug
Yes

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06192641 on ClinicalTrials.gov