The Relation of GnRH Treatment to QTc Interval in Transgender Females

NCT03078829 | Terminated

• 1 other identifier: 16-19936
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Gender Dysphoria

Keywords

gender identity; trans female; GnRH agonists; QTc interval

Outcome Measures

Primary Outcomes (1)

• change in QTc Interval

  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

  6 months

Secondary Outcomes (1)

• QTc interval > 450 milliseconds

  6 months

Study Arms (1)

Trans female adolescents

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

Drug: Treatment with a GnRh agonists

Interventions

Treatment with a GnRh agonists DRUG

All patients will be treated with GnRH agonists

Also known as: histrelin acetate 50mg (SUPPRELIN LA®), l(LUPRON DEPOT®) 30 mg for 3-month injections

Trans female adolescents

Eligibility Criteria

• Age: 10 Years+
• Gender Eligibility Details: Female gender identity
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Transgender males to females meeting entrance criteria who receive care at UCSF CAGC (Child and Adolescent Gender Center) clinic in Mission Bay

You may qualify if:

• Transgender males to females in pubertal stage Tanner stage 4-5
• starting GnRH agonist treatment

You may not qualify if:

• Heart disease or arrhythmias at base line
• Electrolyte abnormalities at baseline (abnormal serum levels of calcium, potassium or magnesium)
• Failure to obtain informed consent from a parent or guarding or informed assent from a youth.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Gender Dysphoria

Interventions

Therapeutics; histrelin; Injections

Condition Hierarchy (Ancestors)

Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: February 28, 2017
• First Posted: March 13, 2017
• Study Start: May 1, 2017
• Primary Completion: August 21, 2017
• Study Completion: August 21, 2017
• Last Updated: December 26, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)