Menstruation; HeavyNCT05722444
Sleep and Health Outcomes in Women With Heavy Menses
A study testing Nighttime Feminine Product in people with Menstruation; Heavy, run by Northwestern University at 1 site in United States.
Trial summary
This study will evaluate subjective sleep over three consecutive menstrual cycles (menses and non-menses) in females reporting heavy menstrual bleeding. Following a baseline phase of one menstrual cycle, study subjects will use a standardized nighttime feminine product during menstruation for their second cycle. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Menstruation; Heavy
- What is being tested?
- Nighttime Feminine Product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2023to 17 Oct 2024
- Phase
- Interventional
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18-50 years old
- Generally healthy (self-assessed; no significant underlying disease)
- Premenopausal patients with regular menstrual cycles every 21 to 35 days
- Patients with at least 3 days and no more than 7 days of bleeding during menstruation
- An intact uterus and at least one ovary
- Ability and willingness to provide written informed consent
Show all 16Show fewer
- Willingness to adhere to study procedures
- Menstrual pads are the primary form for nighttime menstrual protection needs
- Will maintain a daily schedule that allows normal or typical sleep habits (ie, not a night-shift worker; >5 hours of sleep).
- Women will self-report that they have heavy flow and perform at least one of the following compensatory behaviors:
- Set an alarm or plan to get up in the middle of the night to check or change the pad
- Add additional disposable absorbent products for extra leak protection of coverage (e.g. extra pads or liners)
- Use pillows or other means to limit sleep positions (to prevent moving at night)
- Use something extra on top of my bedding (such as a towel) to sleep on
- Wear an extra pair of pants/shorts
- Wear tighter clothing than they typically would, like yoga pants
Who cannot join
- Currently pregnant or intending to imminently attempt pregnancy
- Any condition (social or medical) that, in the opinion of the primary care giver or study staff, would make trial participation unsafe or complicate data interpretation
- Difficult sleeping environment due to:
- Frequently involved in activities requiring nighttime awakenings (eg, taking care of an infant or loved one).
- Disruptive bed partners (i.e., snoring, children, pets, etc)
- Diagnosed sleep disorders (i.e. insomnia, sleep apnea, restless leg disorder, breathing disorder, etc)
- Use of an Intrauterine Device (IUDs) unless copper IUD.
- Regular use (>1 day per week) of sleep aids and/or sedating medications, including over the counter products like melatonin.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Dermatology, Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
About this study
Official title: Investigation of Sleep and Health Outcomes in Women Reporting Heavy Menses Flow
This study will evaluate subjective sleep over three consecutive menstrual cycles (menses and non-menses) in females reporting heavy menstrual bleeding. Following a baseline phase of one menstrual cycle, study subjects will use a standardized nighttime feminine product during menstruation for their second cycle. For the third cycle, subjects will continue to use the standardized menstrual product with behavioral modification that includes refraining from those sleep behaviors used to avoid nighttime menstrual leakage.
- Conditions
- Menstruation; Heavy
- Being tested
- Nighttime Feminine Product
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nighttime Feminine ProductOther
During nights while menstruating:
- Standardized nighttime feminine product + typical nighttime behaviors to prevent leak
- Standardized nighttime feminine product + refraining from nighttime behaviors to prevent leak
| Study group | Role | What they receive |
|---|---|---|
| Women with reported heavy menses | Experimental | Not described Receives: Other: Nighttime Feminine Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pittsburgh Sleep Quality Index (PSQI)
Determine the change in PSQI over the 3 months of study participation. Maximum score is 21 (worse sleep outcomes) and minimum score is 0 (better sleep outcomes).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start6 Feb 2023
- Primary completion10 Apr 2024
- Study completion17 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstruation; HeavyStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica Walter, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05722444
- Sponsor's protocol ID
- STU00215465
- Status last verified
- Jun 2026
- First submitted
- 1 Feb 2023
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Sleep and Health Outcomes in Women Reporting Heavy Menses Flow
- ClinicalTrials.gov ID
- NCT05722444
- Acronym / sponsor ID
- STU00215465
- Conditions
- Menstruation; Heavy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 10 Apr 2024 (actual)
- Study completion
- 17 Oct 2024 (actual)
- First posted
- 10 Feb 2023 (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.
This study will evaluate subjective sleep over three consecutive menstrual cycles (menses and non-menses) in females reporting heavy menstrual bleeding. Following a baseline phase of one menstrual cycle, study subjects will use a standardized nighttime feminine product during menstruation for their second cycle. For the third cycle, subjects will continue to use the standardized menstrual product with behavioral modification that includes refraining from those sleep behaviors used to avoid nighttime menstrual leakage.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with reported heavy menses | Experimental | Other: Nighttime Feminine Product |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Women aged 18-50 years old
- Generally healthy (self-assessed; no significant underlying disease)
- Premenopausal patients with regular menstrual cycles every 21 to 35 days
- Patients with at least 3 days and no more than 7 days of bleeding during menstruation
- An intact uterus and at least one ovary
Key exclusion criteria (8 listed)
- Currently pregnant or intending to imminently attempt pregnancy
- Any condition (social or medical) that, in the opinion of the primary care giver or study staff, would make trial participation unsafe or complicate data interpretation
- Difficult sleeping environment due to:
- Use of an Intrauterine Device (IUDs) unless copper IUD.
- Regular use (>1 day per week) of sleep aids and/or sedating medications, including over the counter products like melatonin.
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 |
|---|---|---|
| Nighttime Feminine ProductDuring nights while menstruating: * Standardized nighttime feminine product + typical nighttime behaviors to prevent leak * Standardized nighttime feminine product + refraining from nighttime behaviors to prevent leak | Other | Women with reported heavy menses |
Primary outcome
Change in Pittsburgh Sleep Quality Index (PSQI)
Time frame: 3 months
Determine the change in PSQI over the 3 months of study participation. Maximum score is 21 (worse sleep outcomes) and minimum score is 0 (better sleep outcomes).
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 9 Jun 2026.
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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 study testing Nighttime Feminine Product in people with Menstruation; Heavy, run by Northwestern University 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 16 inclusion and 8 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: finished, as of the sponsor's last update on 9 Jun 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. 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?
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?
Change in Pittsburgh Sleep Quality Index (PSQI) (time frame: 3 months). 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 9 Jun 2026.