Status and phase
Conditions
Treatments
About
This is a 52-week open label single arm study to investigate the effects of XYOSTED, as testosterone replacement therapy, on adolescent males with either primary or secondary hypogonadism.
The study aims to determine the effectiveness of XYOSTED measured by continuation or induction of puberty in addition to XYOSTED dosage, safety and testosterone levels.
Full description
This is a Phase 3/4, open-label, multicenter study in approximately 100 males 12 to < 18 years of age with primary or secondary hypogonadism (congenital or acquired). Each participant will be screened for eligibility within 28 days before receiving his first dose of study drug on Day 1. During the Screening period, each participant will have a full clinical examination with pubertal staging (ie, Tanner Stage, Table 11), including 2 separate serum total testosterone (TT) measurements obtained in the early morning, where the average (Cavg) will be considered baseline value. Each participant will be categorized as having primary or secondary hypogonadism prior to dosing on Day 1.
Participants meeting all eligibility criteria will be assigned to a starting dose of XYOSTED based on their weight and Targeted Tanner Stage on Day 1. The Targeted Tanner Stage will be determined during Screening by an experienced pediatric endocrinologist.
Participants will have dose adjustments during the study to achieve their Targeted Tanner Stage. Dose adjustments will be based on reviewing the TT concentration between doses (Cmid) by measuring serum TT 14 days after the administration of XYOSTED for participants receiving the Q4W schedule, and 7 days after the administration of XYOSTED for participants who switch to the Q2W schedule. Participants will be evaluated for further dose adjustments approximately every 3 months to achieve the desired targeted TT level
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Diagnosed with a deficiency or absence of endogenous testosterone due to primary or secondary hypogonadism of a known etiology. Children with combined hormone deficiencies are permitted to enroll (but the child must already be receiving treatment for concomitant hormonal deficiencies)
Participants receiving prior testosterone treatment must be receiving a stable dose for at least 12 weeks prior to Screening
Have parent(s) or a legal guardian who will voluntarily provide written informed consent for the child to participate in the study
Willing to provide assent for participation in the study
Be a male 12 to < 18 years of age at the time of consent/assent
Have Legally Authorized Representative who is able to understand and comply with all study procedures and agrees to have the child participate in the study program as outlined in the protocol
Requires chronic pharmacologic support for the initiation and/or continuation of pubertal maturation
Have a body mass index (BMI)-for-age greater than the 5th percentile and weigh ≥ 40 kg
If sexually active with a female partner of child-bearing potential, agrees to:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
100 participants in 1 patient group
Loading...
Central trial contact
Director Clinical Operations, MPH, CPM; Chief Medical Officer, MD, PhD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal