Using melatonin to help women with perimenopausal symptoms
Benefits of Melatonin Use in Patients With Climacterious Symptoms in the Perimenopause: Randomized, Double-blind, Placebo-controlled Clinical Trial
This study is testing if melatonin can help women who are dealing with symptoms of perimenopause feel better over 30 days.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 45 Years and up |
| Sex | Female |
| Sponsor | Univates Academic / other |
| Locations | 1 site (Lajeado, Rio Grande Do Sul) |
| Trial ID | NCT06192641 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effects of melatonin on women experiencing symptoms related to perimenopause. It is a randomized, double-blind, placebo-controlled study involving 40 participants, where half will receive melatonin and the other half a placebo for 30 days. Participants will undergo interviews, complete questionnaires, and provide blood and urine samples for analysis before and after the treatment period. The study aims to assess any changes in symptoms and overall well-being during the treatment.
Who should consider this trial
Good fit: Ideal candidates are women aged 45 and older who are in perimenopause and have experienced irregular menstrual cycles.
Not a fit: Patients with a history of substance abuse, neurological or oncological diseases, ischemic heart disease, liver failure, renal insufficiency, or those currently using certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new non-hormonal treatment option for alleviating perimenopausal symptoms.
How similar studies have performed: While the use of melatonin for various conditions has been explored, this specific application for perimenopausal symptoms is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Lajeado, Rio Grande Do Sul
- Gabriela Laste — Lajeado, Rio Grande Do Sul, Brazil (Recruiting)
Study contacts
- Study coordinator: Gabriela Laste, Ph.D
- Email: gabrielalaste@univates.br
- Phone: 55517147000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.