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Nighttime Feminine Product for Heavy Menstrual Bleeding
N/A
Waitlist Available
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
Study Summary
This trial evaluates how menstrual products & sleep behaviors affect sleep during 3 menstrual cycles for women with heavy bleeding.
Who is the study for?
This trial is for women aged 18-50 with heavy menstrual bleeding who use pads at night and often wake up or take measures to prevent leakage. They must have regular menstrual cycles, an intact uterus, one ovary, and be generally healthy without significant diseases. Night-shift workers or those planning pregnancy are excluded.Check my eligibility
What is being tested?
The study tests how a standardized nighttime feminine product affects sleep during menstruation over three cycles. The first cycle is observed as a baseline; the second involves using the product, and the third adds behavioral changes to avoid leaks.See study design
What are the potential side effects?
There may not be direct side effects from using the nighttime feminine products themselves; however, participants might experience discomfort or disruption in their usual sleep patterns due to adherence to new behaviors required by the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Pittsburgh Sleep Quality Index (PSQI)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Women with reported heavy mensesExperimental Treatment1 Intervention
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Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,601 Previous Clinical Trials
915,634 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Women with reported heavy menses
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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