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Hormone Therapy

high-dose intranasal oxytocin for Tinnitus

N/A
Waitlist Available
Led By Lawrence Newman, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 9

Summary

This trial is testing a nasal spray with high doses of oxytocin to help people with tinnitus. The goal is to see if this hormone can reduce the severity of the ringing in their ears and improve their quality of life.

Eligible Conditions
  • Tinnitus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 9
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 9 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Tinnitus

Side effects data

From 2023 Phase 4 trial • 108 Patients • NCT04028765
6%
Blood transfusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oral Misoprostol-Mothers
Oxytocin-Mothers
Oral Misoprostol-Fetus/Neonate
Oxytocin-Fetus/Neonate

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: high-dose intranasal oxytocinExperimental Treatment1 Intervention
Subjects will be asked to use one spray in one nostril 4 times daily (9AM, 1PM, 5PM and 9 PM). Subjects will take 4 sprays daily of oxytocin for the entire study.
Group II: Nasal sprayPlacebo Group1 Intervention
Subjects swill be asked to use one spray in one nostril 4 times daily (9AM, 1PM, 5PM and 9 PM). The spray can be taken with or without food. Subjects will take 4 sprays daily of the placebo for the entire study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxytocin
2016
Completed Phase 4
~2340

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,409 Previous Clinical Trials
855,785 Total Patients Enrolled
Lawrence Newman, MDPrincipal InvestigatorNYU Langone
~5 spots leftby Nov 2025
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