RecruitingHypogonadism, Male

52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism

Eligible age

12–17 yrs

Accepts

Men

Locations

15 states

Healthy volunteers

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About this study

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.

Sponsor: Halozyme Therapeutics

You may qualify if…

✓ 1. 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)
✓ 2. 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.
✓ 3. Have parent(s) or a legal guardian who will voluntarily provide written informed consent for the child to participate in the study
✓ 4. Willing to provide assent for participation in the study
✓ 5. Be a male 12 to \< 18 years of age at the time of consent/assent
✓ 6. 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
✓ 7. Requires chronic pharmacologic support for the initiation and/or continuation of pubertal maturation
✓ 8. Have a body mass index (BMI)-for-age greater than the 5th percentile and weigh ≥ 30 kg.

You may not qualify if…

✕ 1. Has abnormal thyroid function tests at Screening. May supplement per usual clinical practice and rescreen up to two times.
✕ 2. Has suspected or known constitutional growth delay in growth and puberty (CDGP)
✕ 3. 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)
✕ 4. Has a known allergy or hypersensitivity to XYOSTED, or to any of its ingredients (testosterone enanthate and sesame oil)
✕ 5. Participants receiving prior treatment with testosterone who are not on a stable dose for at least 12 weeks prior to Screening.
✕ 6. Has an allergy to foods or products containing sesame seeds or sesame oil
✕ 7. 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.
✕ 8. 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.