52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testostero… (NCT06689085) | Clinical Trial Compass
RecruitingPhase 3
52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism
United States100 participantsStarted 2025-03-07
Plain-language summary
This is a 52-week open label single arm study + 24-Month long-term safety extension 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.
Who can participate
Age range
12 Years – 17 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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. Treatment naive participants are permitted to enroll.
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Increase in testosterone, as evaluated using PK parameters
Timeframe: From Enrollment through End of Study Assessments at Week 53
. 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 ≥ 30 kg.
Exclusion criteria
. Has abnormal thyroid function tests at Screening. May supplement per usual clinical practice and rescreen up to two times.
. Has suspected or known constitutional growth delay in growth and puberty (CDGP)
. Has evidence of possible nutritional or gastrointestinal disorder that may impact growth (e.g., abrupt weight loss within the 3 months prior to Screening, unmanaged celiac disease, inflammatory bowel disease)
. Has a known allergy or hypersensitivity to XYOSTED, or to any of its ingredients (testosterone enanthate and sesame oil)
. Participants receiving prior treatment with testosterone who are not on a stable dose for at least 12 weeks prior to Screening.
. Has an allergy to foods or products containing sesame seeds or sesame oil
. Has Stage 1 hypertension, defined as the average of 2 or more seated right arm BP measurements exceeding the 95th percentile for age, sex, and height, or SBP ≥ 130 mm Hg and/or DBP ≥ 80 mm Hg at Screening or Day 1.
. Has a clinically significant abnormal clinical laboratory test value at Screening, as determined by the Investigator including hematocrit \> 48%, or \>50% for patients living at high altitude if not receiving testosterone treatment, or hematocrit \> 52% if already receiving testosterone treatment.