BridgeMD
Tests treatment safety and results for Hypogonadism, Male
Official title 52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism
ClinicalTrials.gov ID: NCT06689085
What this study is testing
What is Testosterone enanthate?
Testosterone enanthate is an investigational medicine, being studied as a potential treatment for hypogonadism, male.
Also referred to as XYOSTED Injection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 17, men only
You may be able to join if
- Diagnosed with a deficiency or absence of endogenous testosterone due to primary or secondary hypogonadism of a known etiology. Children with...
- Participants receiving prior testosterone treatment must be receiving a stable dose for at least 12 weeks prior to Screening. Treatment naive...
- 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
You likely can't join if
- 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...
- 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
See the full eligibility criteria
Who can join
- 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...
- 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
- 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.
- If sexually active with a female partner of child-bearing potential, agrees to:
- Practice true abstinence including 30 days after the last IP administration, or,
- Use 2 adequate forms of highly effective contraception, one of which should be a physical barrier, during the study and for 30 days after the last IP administration.
What rules you out
- 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...
- Has a history of deep venous thrombosis or pulmonary embolism
- Has evidence of a clinically significant 12-lead electrocardiogram (ECG) abnormality at Screening, as determined by the Investigator
- Has a current suspected or diagnosed (and unresected) tumor of the pituitary gland with the exception of Rathke's cleft cyst or a stable non-functioning pituitary microadenoma (ie, lesion size \< 10 mm that has not...
- Has an active malignancy or has received treatment for a malignancy within the 12 months before Screening
- Is currently receiving antipsychotic medication for any reason or is currently receiving selective serotonin reuptake inhibitor (SSRI) medication for depression
- Is receiving any other medication or has a condition that would preclude safe participation in the study or confound the evaluation of safety, as determined by the Investigator
- Has a history of suicidal behavior (i.e., actions intended to harm oneself), suicidal ideation (i.e., thoughts and plans about suicide), or suicide attempts
- Has any affirmative responses on the Columbia Suicide Severity Rating Scale (C-SSRS) questionnaire to questions #3, #4, or #5 or any affirmative response to questions #1 or #2 within the past 12 months on the suicide...
- Is currently taking supraphysiologic doses of systemic glucocorticoids for more than 3 weeks, except for intermittent short courses of exogenous glucocorticoids as needed for the treatment of asthma
- Has received any other investigational compound within 1 month prior to screening or 5 half-lives of the investigational product (whichever is longer)
- Has received gonadotropin-releasing hormone (GnRH) agonists, aromatase inhibitors, androgens (eg, dehydroepiandrosterone [DHEA]), anabolic steroids such as oxandrolone, or other sex steroids within 12 months before the...
- Receiving cytochrome P450 (CYP) 3A4 or P glycoprotein (P-gp) inhibitors/inducers or medications that are metabolized by CYP3A4 or P-gp within 30 days of enrolment.
- Has a history of alcohol or drug abuse
- Has a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other conditions that would preclude participation in the study, as determined by the...
- Has chronic urticaria or dermatographism
- Has 25-hydroxy-vitamin D blood level \< 20 ng/mL. Participants with initial vitamin D blood measurement \< 20 ng/mL may enroll while they receive supplementation per clinical practice
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- Jacksonville, Florida, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Worcester, Massachusetts, United States
- Minneapolis, Minnesota, United States
- St Louis, Missouri, United States
- Las Vegas, Nevada, United States
- The Bronx, New York, United States
- Oklahoma City, Oklahoma, United States
- Philadelphia, Pennsylvania, United States
- Columbia, South Carolina, United States
- El Paso, Texas, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
- Seattle, Washington, United States
- Tacoma, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 12 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; San Diego, California, United States; San Francisco, California, United States; Aurora, Colorado, United States; Jacksonville, Florida, United States; Chicago, Illinois, United States and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.