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NCT03078829 · ClinicalTrials.gov registry record
The Relation of GnRH Treatment to QTc Interval in Transgender Females
A clinical trial, sponsored by University of California, San Francisco.
- Terminated
- Registry status
- 3
- Enrollment target
NCT03078829: Clinical Trial study, sponsored by University of California, San Francisco.
NCT03078829 is a clinical trial that was terminated before completion, run by University of California, San Francisco. The registered enrollment target is 3 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03078829 was terminated before completion, sponsored by University of California, San Francisco.
- TERMINATED
- Registry status
- 3 participants
- Enrollment target
Study Summary
Background: The QT interval of the electrocardiogram (ECG), corrected for heart rate (QTc), is a measure of the duration of ventricular repolarization and is a widely used marker of ventricular arrhythmia risk. Testosterone has a shortening effect on QTc length, and the QTc interval in males is shorter than in females after the onset of puberty. Transgender female adolescents are treated with GnRH agonists or spironolactone that suppress endogenous testosterone secretion and might increase the QT interval sufficiently to increase the risk for malignant ventricular arrhythmias. There are no current guidelines regarding monitoring QTc interval in transgender females undergoing GnRH agonist treatment. Objective: To assess the effect of GnRH agonist treatment on QTc interval in transfemale youth. Methods: A quasi-experimental time series study of transgender female adolescent, seen at UCSF Child and Adolescent Gender Center (CAGC) during 2017-2019. Specific aims: To assess the impact of GnRH agonist treatment on QTc interval length in transgender female adolescent
Primary Outcome
A 12-lead ECG will be performed using standardized inspected equipment, at baseline and after 6 months of treatment, difference in milliseconds will be calculates
Interventions
- DRUG Treatment with a GnRh agonists
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2017-05-01 |
| Est. Completion | 2017-08-21 |
Why NCT03078829 stopped before completion
NCT03078829 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 3 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Treatment with a GnRh agonists is the first listed.
NCT03078829 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03078829 about?
NCT03078829 is a clinical study titled "The Relation of GnRH Treatment to QTc Interval in Transgender Females". Background: The QT interval of the electrocardiogram (ECG), corrected for heart rate (QTc), is a measure of the duration of ventricular repolarization and is a widely used marker of ventricular arrhythmia risk. Testosterone has a shortening effect on QTc length, and the QTc interval in males is shor...
What is the current status of trial NCT03078829?
This trial is currently terminated. The enrollment target is 3 participants. The study started on 2017-05-01. Estimated completion is 2017-08-21.
What interventions are being tested in trial NCT03078829?
The interventions under investigation include: Treatment with a GnRh agonists (DRUG).
Who is sponsoring clinical trial NCT03078829?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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