San Diego, CANCT06689085Now EnrollingIRB Ready

Low Testosterone Clinical Trial in San Diego, CA

Access cutting-edge low testosterone treatment through this phase 3 clinical trial at a research site in San Diego. Study-provided care at no cost to qualified participants.

Sponsored by Halozyme Therapeutics

Quick Self-Assessment

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Expert Care in San Diego

Access low testosterone specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related low testosterone treatment provided free

Apply for This San Diego Location

Check if you qualify for this low testosterone clinical trial in San Diego, CA

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to San Diego

    Convenient for CA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit San Diego site if eligible
  4. 4Begin participation

About This Low Testosterone Study in San Diego

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.

Sponsor: Halozyme Therapeutics

Who Can Participate

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
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.

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.
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 increased in size over a period of 1 year on repeat imaging), as determined by the Investigator
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 ideation questions (first section) OR any affirmative response on the suicidal behavior questions (the second section).
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 Screening visit, or would require these treatments at any time during the study.
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 Investigator
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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in San Diego?

Yes, this clinical trial (NCT06689085) has an active research site in San Diego, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Low Testosterone Treatment Options in San Diego, CA

If you're searching for low testosterone treatment options in San Diego, CA, this clinical trial (NCT06689085) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our San Diego research site is actively enrolling participants for this phase 3 clinical trial. You'll receive care from experienced low testosterone specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

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Take the first step toward participating in this groundbreaking clinical trial

Secure · Expert Care · San Diego, CA