Melatonin Use in Patients With Climacterious Symptoms in the Perimenopause

NCT06192641 | Completed Phase 2 FDA Drug

• 1 other identifier: 10901364
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (1)

• Menopause rating scale

  Menopause scale, 0-44, higher score worse outcome

  one month

Secondary Outcomes (5)

• Beck Depression Inventory II

  one month

• Pittsburgh Sleep Quality Index

  one month

• Visual Analog Pain Scale

  daily for one month

• Hamilton scale

  one month

• Visual analogue scale of sleep

  daily for one month

Study Arms (2)

Melatonin

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Melatonin 3 MG DRUG

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).

Also known as: melatonin

Melatonin; Placebo

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 45 years or older
• Be literate

You may not qualify if:

• 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)

Sponsors & Collaborators

• Univates: lead
• Aline Patrícia Brietzke: collaborator
• Ana Paula Costella: collaborator

Study Sites (1)

Gabriela Laste

Lajeado, Rio Grande do Sul, 95900-000, Brazil

Location

MeSH Terms

Interventions

Melatonin

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: To control possible measurement biases, in the present study, the following measures will be taken: for the pharmacological intervention (use of melatonin or placebo), the evaluators and patients will be blinded to the intervention. The randomization codes will remain in the care of two evaluators not involved in the care of the patients, which allows better control of manipulations to favor any intervention to be carried out. Patients will be instructed to discuss all aspects related to pharmacological interventions with the researcher during treatment. The sealed envelope method will be used for confidential allocation. Before the recruitment phase, envelopes containing protocol materials will be prepared. Each envelope containing the allocated treatment will be sealed and numbered sequentially. After each participant agrees to participate in the study, the envelope will be opened and the results will be reported to the researcher who will carry out the interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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).

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 5, 2024
• Study Start: October 20, 2023
• Primary Completion: November 30, 2024
• Study Completion: December 20, 2024
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)