PerimenopauseNCT06826755
Melatonin Effects on Cardiovascular Disease Mechanisms in Midlife Women: A Randomized Clinical Trial
A study testing Terry Naturally® melatonin 5mg SR in people with Perimenopause and Hypertension, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to study the effects of 12 weeks of melatonin supplementation compared to placebo in women who are in the menopause transition (perimenopause) and have high blood pressure. Read more about this study
- Who is it for?
- Ages 40 to 55 years, women only
- Conditions the study is for
- Perimenopause, Hypertension
- What is being tested?
- Terry Naturally® melatonin 5mg SR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2025to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 40-55 years old
- Female individuals with intact uterus and at least one ovary
- Hypertension
- o Defined as a prior diagnosis of hypertension, use of antihypertensive agents, or office SBP/DBP ≥130/80 mmHg
- On stable medical regimen (≥ 2 months) if taking other medications
Who cannot join
- Prescription sleeping medications or melatonin supplementation
- Pregnant or lactating
- Use of tobacco, nicotine or vaping products
- Night shift work
- On prescription aspirin
- Severe lactose intolerance
Show all 14Show fewer
- History of substance use disorder
- History of suicidal ideation
- History of clinically diagnosed anemia (within the past 5 years) or low hemoglobin levels (<11.6 g/dL) within the past 12 months
- Active cancer
- Severe daytime sleepiness (score >15 at the Epworth Sleepiness Scale [ESS])81
- Current or recent (within the past 2 months) participation in other research studies at the discretion of study investigators
- Inability to provide written consent and/or to speak and read English
- Any other medical, geographic, or social factor making study participation impractical
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Naima Covassin, Ph.D., Covassin.Naima@mayo.edu
Naima Covassin, Ph.D.
About this study
The purpose of this research is to study the effects of 12 weeks of melatonin supplementation compared to placebo in women who are in the menopause transition (perimenopause) and have high blood pressure.
- Conditions
- Perimenopause, Hypertension
- Being tested
- Terry Naturally® melatonin 5mg SR, Placebo
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Terry Naturally® melatonin 5mg SRDietary supplement
Participants will take SR melatonin 5mg (or placebo) orally 1 hour before bed, for approximately 12 weeks. The study is comparing the effects of melatonin supplementation vs. placebo on cardiovascular risk measures in perimenopausal women.
PlaceboDietary supplement
Participants will take SR melatonin 5mg (or placebo) orally 1 hour before bed, for approximately 12 weeks. The study is comparing the effects of melatonin supplementation vs. placebo on cardiovascular risk measures in perimenopausal women.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | placebo will be taken orally once daily, one hour before bedtime. Placebo will be prepared as capsules of identical appearance and taste, using lactose powder as filler. Receives: Dietary Supplement: Placebo |
| Melatonin | Other | Melatonin will be taken orally once daily, one hour before bedtime. The use of melatonin is not experimental but rather to observe its effects vs. placebo on cardiovascular risk measures in perimenopausal women. Receives: Dietary Supplement: Terry Naturally® melatonin 5mg SR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Nocturnal Systolic Blood Pressure (SBP)
Measured using 24-hour ambulatory blood pressure (ABP) monitoring, including nighttime BP levels and nocturnal BP dipping.
Measured: Measured at baseline and at the end of the 12-week intervention
Change in Nocturnal Diastolic Blood Pressure (DBP)
Measured using 24-hour ambulatory blood pressure (ABP) monitoring, including nighttime BP levels and nocturnal BP dipping.
Measured: Measured at baseline and at the end of the 12-week intervention.
Secondary outcomes (1)
Change in Oxidative Stress Markers
Assessed using Blood and urine samples analyzed by Mayo Clinic Laboratories.
Measured: Measured at baseline and at the end of the 12-week intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start23 May 2025
- Primary completionSep 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PerimenopauseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naima Covassin, Mayo Clinic
- Investigators
- Naima Covassin, Ph.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826755
- Sponsor's protocol ID
- 24-008966
- Status last verified
- Jul 2026
- First submitted
- 10 Feb 2025
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melatonin Effects on Cardiovascular Disease Mechanisms in Midlife Women: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06826755
- Acronym / sponsor ID
- 24-008966
- Conditions
- Perimenopause, Hypertension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 23 May 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 14 Feb 2025 (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.
The purpose of this research is to study the effects of 12 weeks of melatonin supplementation compared to placebo in women who are in the menopause transition (perimenopause) and have high blood pressure.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placeboplacebo will be taken orally once daily, one hour before bedtime. Placebo will be prepared as capsules of identical appearance and taste, using lactose powder as filler. |
| Melatonin | Other | Dietary Supplement: Terry Naturally® melatonin 5mg SRMelatonin will be taken orally once daily, one hour before bedtime. The use of melatonin is not experimental but rather to observe its effects vs. placebo on cardiovascular risk measures in perimenopausal women. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 40-55 years old
- Female individuals with intact uterus and at least one ovary
- Hypertension
- o Defined as a prior diagnosis of hypertension, use of antihypertensive agents, or office SBP/DBP ≥130/80 mmHg
- On stable medical regimen (≥ 2 months) if taking other medications
Key exclusion criteria (14 listed)
- Prescription sleeping medications or melatonin supplementation
- Pregnant or lactating
- Use of tobacco, nicotine or vaping products
- Night shift work
- On prescription aspirin
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 |
|---|---|---|
| Terry Naturally® melatonin 5mg SRParticipants will take SR melatonin 5mg (or placebo) orally 1 hour before bed, for approximately 12 weeks. The study is comparing the effects of melatonin supplementation vs. placebo on cardiovascular risk measures in perimenopausal women. | Dietary supplement | Melatonin |
| PlaceboParticipants will take SR melatonin 5mg (or placebo) orally 1 hour before bed, for approximately 12 weeks. The study is comparing the effects of melatonin supplementation vs. placebo on cardiovascular risk measures in perimenopausal women. | Dietary supplement | Placebo |
Primary outcome
Change in Nocturnal Systolic Blood Pressure (SBP)
Time frame: Measured at baseline and at the end of the 12-week intervention
Measured using 24-hour ambulatory blood pressure (ABP) monitoring, including nighttime BP levels and nocturnal BP dipping.
Change in Nocturnal Diastolic Blood Pressure (DBP)
Time frame: Measured at baseline and at the end of the 12-week intervention.
Measured using 24-hour ambulatory blood pressure (ABP) monitoring, including nighttime BP levels and nocturnal BP dipping.
1 secondary outcome
Change in Oxidative Stress Markers
Time frame: Measured at baseline and at the end of the 12-week intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- 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.
Naima Covassin, Ph.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Terry Naturally® melatonin 5mg SR in people with Perimenopause and Hypertension, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 13 Aug 2026. 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 United States. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Perimenopause Study Team (507-255-8897, PerimenopauseStdy@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Nocturnal Systolic Blood Pressure (SBP) (time frame: Measured at baseline and at the end of the 12-week intervention). The study lists 2 primary outcomes in all. 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 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.