NCT05722444

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

February 6, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 10, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2024

Completed
Last Updated

June 9, 2026

Status Verified

June 1, 2026

Enrollment Period

1.2 years

First QC Date

February 1, 2023

Last Update Submit

June 5, 2026

Conditions

Menstruation; Heavy

Outcome Measures

Primary Outcomes (1)

  • 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).

    3 months

Study Arms (1)

Women with reported heavy menses

EXPERIMENTAL
Other: Nighttime Feminine Product

Interventions

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

Women with reported heavy menses

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParticipants who are born female/undergoing menstruation.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • 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
  • +1 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology, Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Menorrhagia

Condition Hierarchy (Ancestors)

Uterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsMenstruation Disturbances

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 1, 2023

First Posted

February 10, 2023

Study Start

February 6, 2023

Primary Completion

April 10, 2024

Study Completion

October 17, 2024

Last Updated

June 9, 2026

Record last verified: 2026-06

Locations

US(1)