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Hormone Therapy

Melatonin for Sleep

N/A
Waitlist Available
Led By Lisa E Olson, Ph.D.
Research Sponsored by University of Redlands
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 from immediately prior to administration to 48 hours post administration
Awards & highlights

Summary

This trial will compare how quickly melatonin from lotions and bubble baths is absorbed compared to oral tablets, and how long it stays in the body.

Who is the study for?
This trial is for University of Redlands students who are interested in how melatonin, a sleep-promoting hormone, works when taken in different forms. It's not suitable for those with allergies to scented lotions or bath products, or for pregnant individuals.Check my eligibility
What is being tested?
Researchers are testing the absorption and duration of melatonin in the body when administered as an oral tablet, lotion, and bubble bath to compare which method is most effective at delivering the hormone.See study design
What are the potential side effects?
Melatonin typically has mild side effects that can include drowsiness during waking hours, slight changes in blood pressure, vivid dreams or morning grogginess. The study will monitor if these vary by application method.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from immediately prior to administration to 48 hours post administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and from immediately prior to administration to 48 hours post administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Salivary melatonin level
Secondary outcome measures
Side effects

Side effects data

From 2014 Phase 2 trial • 40 Patients • NCT01114373
42%
Fatigue
39%
Early Morning Wakening
36%
Daytime drowsiness
11%
Weakness
11%
Dizziness
11%
Nausea
11%
Blurred vision
100%
80%
60%
40%
20%
0%
Study treatment Arm
Melatonin
Placebo

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: LotionExperimental Treatment1 Intervention
Dr. Teal's Sleep Lotion with Melatonin, Lavender, and Chamomile. 3 g lotion applied to one arm (without washing for at least 4 hours).
Group II: Bubble bathExperimental Treatment1 Intervention
Dr. Teal's Sleep Bath with Melatonin, Lavender, and Chamomile. 40L warm tap water maintained between 36.5 - 40 degrees C (98 - 104 degrees F) and 2 ml bubble bath. Participants will soak their feet and legs in the cooler for 15 minutes and then dry off (without rinsing or washing for at least 4 hours).
Group III: Oral tabletActive Control1 Intervention
3 mg Tablets (Nature Made). Participants will need to fast for 2 hours prior to consumption and 2 hours after consumption.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Melatonin
2014
Completed Phase 4
~1150

Find a Location

Who is running the clinical trial?

University of RedlandsLead Sponsor
2 Previous Clinical Trials
83 Total Patients Enrolled
1 Trials studying Sleep
63 Patients Enrolled for Sleep
Lisa E Olson, Ph.D.Principal InvestigatorUniversity of Redlands
1 Previous Clinical Trials
20 Total Patients Enrolled
~6 spots leftby Dec 2024