Perimenopausal DisorderPhase 2NCT06192641
Melatonin Use in Patients With Climacterious Symptoms in the Perimenopause
A Phase 2 study testing Melatonin 3 MG in people with Perimenopausal Disorder, run by Univates at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Perimenopausal Disorder
- What is being tested?
- Melatonin 3 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Oct 2023to 20 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 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.
Read the 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 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.
- Conditions
- Perimenopausal Disorder
- Being tested
- Melatonin 3 MG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin 3 MGDrug
Also called melatonin
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Melatonin 3 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menopause rating scale
Menopause scale, 0-44, higher score worse outcome
Measured: one month
Secondary outcomes (5)
Beck Depression Inventory II
Level of depressive symptoms, 0-63, higher score worse outcome. Score 16 is considered depression.
Measured: one month
Pittsburgh Sleep Quality Index
Sleep quality, 0-20, higher score worse sleep
Measured: one month
Visual Analog Pain Scale
pain scale, can vary from zero (no pain) to 100 mm (worst possible pain)
Measured: daily for one month
Hamilton scale
anxiety rating scale, 0-56, >30 severe anxiety.
Measured: one month
Visual analogue scale of sleep
sleep scale, varies from worst possible (0) to best possible (10 cm)
Measured: daily for one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start20 Oct 2023
- Primary completion30 Nov 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perimenopausal DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model 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.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).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Univates
- Sponsor type
- University, hospital or other
- Collaborators
- Aline Patrícia Brietzke, Ana Paula Costella
- Responsible party
- Principal investigator, Gabriela Laste, Univates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192641
- Sponsor's protocol ID
- 10901364
- Status last verified
- Nov 2025
- First submitted
- 19 Dec 2023
- Last updated
- 13 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Melatonin Use in Patients With Climacterious Symptoms in the Perimenopause: Randomized, Double-blind, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06192641
- Acronym / sponsor ID
- 10901364
- Conditions
- Perimenopausal Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- UnivatesUniversity, hospital or other
- Collaborators
- Aline Patrícia Brietzke, Ana Paula Costella
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model 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.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).
| Arm | Type | Receives |
|---|---|---|
| Melatonin | Active comparator | Drug: Melatonin 3 MGPatients 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 | Placebo comparator | Drug: Melatonin 3 MGPatients 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatonin 3 MGAlso: melatoninpatients 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). | Drug | Melatonin, Placebo |
Primary outcome
Menopause rating scale
Time frame: one month
Menopause scale, 0-44, higher score worse outcome
5 secondary outcomes
Beck Depression Inventory II
Time frame: one month
Pittsburgh Sleep Quality Index
Time frame: one month
Visual Analog Pain Scale
Time frame: daily for one month
Hamilton scale
Time frame: one month
Visual analogue scale of sleep
Time frame: daily for one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Melatonin 3 MG in people with Perimenopausal Disorder, run by Univates at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menopause rating scale (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2025.