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Sleep and Health Outcomes in Women With Heavy Menses

NCT05722444 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-03-27

No results posted yet for this study

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.

Conditions

  • Menstruation; Heavy

Interventions

OTHER

Nighttime Feminine Product

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

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-06
Primary Completion
2024-04-30
Completion
2024-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05722444 on ClinicalTrials.gov