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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 45
Healthy Volunteers: f
View:

• Age 45 years or older

• Be literate

Locations
Other Locations
Brazil
Gabriela Laste
RECRUITING
Lajeado
Contact Information
Primary
Gabriela Laste, Ph.D
gabrielalaste@univates.br
55517147000
Time Frame
Start Date: 2023-10-20
Estimated Completion Date: 2025-02-20
Participants
Target number of participants: 40
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Collaborators: Aline Patrícia Brietzke, Ana Paula Costella
Leads: Univates

This content was sourced from clinicaltrials.gov