Last updated: March 25, 2024
Sponsor: Northwestern University
Overall Status: Active - Not Recruiting
Phase
N/A
Condition
Heavy Bleeding / Heavy Periods
Female Hormonal Deficiencies/abnormalities
Dysfunctional Uterine Bleeding
Treatment
Nighttime Feminine Product
Clinical Study ID
NCT05722444
STU00215465
Ages 18-50 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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 anight-shift worker; >5 hours of sleep).
- Women will self-report that they have heavy flow and perform at least one of thefollowing compensatory behaviors:
- Set an alarm or plan to get up in the middle of the night to check or change thepad
- Add additional disposable absorbent products for extra leak protection ofcoverage (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
Exclusion
Exclusion Criteria:
- Currently pregnant or intending to imminently attempt pregnancy
- Any condition (social or medical) that, in the opinion of the primary care giver orstudy staff, would make trial participation unsafe or complicate data interpretation
- Difficult sleeping environment due to:
- Frequently involved in activities requiring nighttime awakenings (eg, taking careof 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, includingover the counter products like melatonin.
Study Design
Total Participants: 25
Treatment Group(s): 1
Primary Treatment: Nighttime Feminine Product
Phase:
Study Start date:
February 06, 2023
Estimated Completion Date:
May 31, 2024
Connect with a study center
Department of Dermatology, Northwestern University Feinberg School of Medicine
Chicago, Illinois 60611
United StatesSite Not Available
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