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Trial · Observational

TerminatedPhase not statedRegistry data

The Relation of GnRH Treatment to QTc Interval in Transgender Females

NCTNCT03078829 (opens ClinicalTrials.gov in a new tab)Other id16-19936
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Phase not stated
Enrollment
3 participants (actual)
Sponsor
University of California, San Francisco · Other
Design
Not stated
Countries
1 country

United States

Start
1 May 2017
Primary completion
21 Aug 2017
Completion
21 Aug 2017
First posted
13 Mar 2017
Last update posted
26 Dec 2018
Conditions
Gender Dysphoria

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20172018
  1. Ph –

    The Relation of GnRH Treatment to QTc Interval in Transgender Females

    NCT03078829

    1 May 2017 to 21 Aug 2017

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • Treatment with a GnRh agonistsDrug

Arms1

  • Other

    Trans female adolescents

    All transgender males to females youth in pubertal stage Tanner stage 4-5, starting GnRH agonist and estrogen treatment

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. change in QTc Interval

    Time frame · 6 months

    Registry description

    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

Secondary outcomes(1)

  1. QTc interval > 450 milliseconds

    Time frame · 6 months

    Registry description

    number of participants with QTc \> 450 milliseconds at 6 months

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 10 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Transgender males to females in pubertal stage Tanner stage 4-5 2. starting GnRH agonist treatment Exclusion Criteria: 1. Heart disease or arrhythmias at base line 2. Electrolyte abnormalities at baseline (abnormal serum levels of calcium, potassium or magnesium) 3. Failure to obtain informed consent from a parent or guarding or informed assent from a youth.

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