Comparing Subcutaneous Testosterone to Intramuscular Testosterone in Gender Affirming Care of Transgender Male Adolescents

NCT03864913 | Completed Early Phase 1 FDA Drug

• 1 other identifier: STUDY00017454
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The trial studies the efficacy of subcutaneous (SQ) testosterone compared to intramuscular (IM) testosterone therapy during the first 6 months of pubertal induction in transgender male adolescents. Describes rate of adverse effects, masculinizing effects and quality of life while receiving testosterone. Evaluates clinic utilization required for testosterone therapy.

Conditions

Health Services for Transgender Persons; Transgender Persons

Keywords

Gender affirming care

Outcome Measures

Primary Outcomes (1)

• Serum testosterone level

  Trough and peak serum testosterone level

  Two lab draws, before and after testosterone injection, drawn at 3 month and 6 month follow up

Secondary Outcomes (4)

• Rate of adverse effects

  Assessed at 3 month and 6 month follow up

• PedsQL questionnaire score

  Completed at baseline, 3 month and 6 month follow up

• Masculinizing effects

  Completed at 3 month and 6 month follow up

• Medication experience

  Completed at 3 month and 6 month follow up

Study Arms (3)

Randomized SQ vs IM

EXPERIMENTAL

Subjects randomized to either SQ or IM testosterone injections follow study protocol.

Drug: Testosterone injection; Behavioral: PedsQL questionnarie; Other: Masculinizing effects questionnaire; Other: Medication experience questionnaire

Non-randomized SQ

EXPERIMENTAL

Subjects choose to participate in study, but decline to randomize and select SQ injections. Follow same study protocol.

Drug: Testosterone injection; Behavioral: PedsQL questionnarie; Other: Masculinizing effects questionnaire; Other: Medication experience questionnaire

Non-randomized IM

EXPERIMENTAL

Subjects choose to participate in study, but decline to randomize and select IM injections. Follow same study protocol.

Drug: Testosterone injection; Behavioral: PedsQL questionnarie; Other: Masculinizing effects questionnaire; Other: Medication experience questionnaire

Interventions

Testosterone injection DRUG

SQ or IM testosterone injections for pubertal induction of transgender male adolescents. Increasing doses per protocol at 3 month and 6 month follow up.

Non-randomized IM; Non-randomized SQ; Randomized SQ vs IM

PedsQL questionnarie BEHAVIORAL

Validated Pediatric Quality of Life questionnaire completed by subjects at baseline, 3 month and 6 month study visits.

Non-randomized IM; Non-randomized SQ; Randomized SQ vs IM

Masculinizing effects questionnaire OTHER

Subjects complete self-reported questionnaire at 3 month and 6 month study visits.

Non-randomized IM; Non-randomized SQ; Randomized SQ vs IM

Medication experience questionnaire OTHER

Subjects complete self-reported questionnaire at 3 month and 6 month study visits.

Non-randomized IM; Non-randomized SQ; Randomized SQ vs IM

Eligibility Criteria

• Age: 14 Years - 19 Years
• Gender Eligibility Details: Transgender male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Testosterone naive
• Transgender male
• years old

You may not qualify if:

• Transgender males who have received testosterone therapy in the past

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Interventions

Testosterone

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Kara Connelly, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized arm (SQ, IM), as well as non-randomized SQ and non-randomized IM.

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: March 6, 2019
• Study Start: January 26, 2018
• Primary Completion: June 30, 2019
• Study Completion: December 30, 2019
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)