Testosterone Therapy
Clinical Informed Consent

Purpose & Document Stack

This document is the clinical informed consent for evaluation and treatment of andropause and low testosterone with Testosterone Replacement Therapy (TRT) and adjunctive hormone optimization at Navara Health, PLLC. It addresses the clinical nature, risks, benefits, alternatives, monitoring requirements, fertility considerations, and patient responsibilities specific to testosterone therapy.

Nature of Treatment

I hereby consent to evaluation and treatment by Navara Health, PLLC and Jessica Boggs, APRN, FNP-C, ENP-C for:

• Andropause or symptoms of low testosterone (hypogonadism)
• Hormone imbalances involving testosterone, estradiol, DHEA, pregnenolone, or thyroid function
• Metabolic, cognitive, sexual, or functional symptoms related to declining androgens

Treatment may involve:

• Testosterone replacement therapy (TRT) — injectable testosterone cypionate or enanthate (intramuscular or subcutaneous, typically up to 200 mg weekly with weekly or twice-weekly administration), or compounded topical testosterone cream or gel
• Adjunctive hormone medications — HCG, enclomiphene, anastrozole (used sparingly), DHEA, pregnenolone, oxytocin
• Thyroid optimization — when clinically indicated
• Nutritional, lifestyle, and pharmaceutical interventions — designed to support hormonal balance

Clinical Philosophy

Navara Health prescribes testosterone with the goal of restoring physiologic ranges (typically targeting the mid-to-upper normal range for the patient's age). Supraphysiologic dosing is not provided. Estradiol in men is managed primarily through dose and frequency optimization, with aromatase inhibitors reserved for symptomatic patients with significantly elevated estradiol after dose optimization has been attempted.

Off-Label Use Acknowledgment

I acknowledge that:

• Testosterone therapy is FDA-approved for the treatment of classical hypogonadism — primary testicular failure or hypothalamic/pituitary dysfunction confirmed by laboratory testing
• Use of testosterone therapy for wellness, anti-aging, age-related testosterone decline, body composition, or general health optimization in the absence of classical hypogonadism is considered off-label
• BHRT, thyroid optimization, and adjunctive hormone manipulation in men are similarly often considered off-label
• Off-label use is legal, common, and accepted in medical practice and is at the provider's clinical discretion
• I am voluntarily electing to pursue hormone therapy to address my symptoms and treatment goals

Alternatives to Treatment

I understand that alternative approaches include:

• No treatment — allowing hormone levels to remain at current values, with monitoring
• Lifestyle modification — weight loss, resistance training, sleep optimization, stress management, dietary changes (these alone can meaningfully improve testosterone in many men)
• Treatment of underlying causes — sleep apnea, metabolic syndrome, alcohol use, certain medications, opioid use, all of which can suppress testosterone
• Enclomiphene or clomiphene — selective estrogen receptor modulators that stimulate endogenous testosterone production while preserving fertility (see Section 9, Fertility Preservation Pathway)
• HCG monotherapy — for men with secondary hypogonadism who wish to preserve fertility
• Specialist referral — endocrinology, urology, or reproductive medicine
• Over-the-counter supplements aimed at supporting natural testosterone production (limited and variable evidence)

I understand these alternatives and voluntarily consent to the treatment plan offered by Navara Health.

FDA Boxed Warning & Federal Safety Communications

Recent large-scale randomized trial data, including the TRAVERSE trial (2023), did not demonstrate increased major cardiovascular events in middle-aged and older men with confirmed hypogonadism receiving well-monitored TRT. However, individual cardiovascular risk varies, and the long-term cardiovascular risk profile of TRT remains an area of ongoing research.

Clinical Risks & Side Effects

I understand that most mild side effects can be managed by dose adjustment, frequency change, or supportive treatment. I will report side effects promptly so they can be addressed before they progress.

Topical Testosterone Precautions

Potential Benefits (Not Guaranteed)

Navara Health may recommend testosterone therapy when clinically appropriate. Potential benefits described in clinical literature may include:

• Improved libido, sexual function, and erectile function
• Increased energy and stamina
• Improved muscle tone, mass, and strength
• Enhanced mood, cognition, and motivation
• Reduced fat mass and improved body composition
• Improved metabolic health
• Improved bone density and reduced osteoporosis risk
• Possible improvement in certain long-term disease risks when properly monitored

I understand that benefits are not guaranteed, vary substantially between individuals, depend on appropriate dosing and monitoring, and may take 3–6 months or longer to fully manifest.

Monitoring Requirements

Baseline Laboratory Panel (Prior to Initiation)

• Total and free testosterone, SHBG
• Estradiol (sensitive assay)
• LH and FSH — to characterize primary vs. secondary hypogonadism
• Prolactin — to rule out pituitary contribution to hypogonadism
• PSA — for all men prior to initiation
• CBC with hematocrit (for erythrocytosis monitoring)
• CMP (liver and kidney function, electrolytes)
• Lipid panel
• Thyroid panel — TSH, free T3, free T4
• Vitamin D
• DHEA-S
• HbA1c (when indicated)
• Additional labs as clinically indicated

Monitoring Cadence

• Baseline labs prior to initiation — all of the above
• Quarterly labs (every 12 weeks) during the titration phase — while dose, frequency, or route is being adjusted to achieve target therapeutic levels
• Annual labs once optimized — once dose is stable and therapeutic levels are confirmed, monitoring transitions to a yearly cadence including testosterone, estradiol, CBC, CMP, lipids, PSA, thyroid, and other markers as clinically indicated
• More frequent monitoring may be reinstated if labs become abnormal, dose changes are required, or new symptoms develop
• Annual prostate assessment — PSA, with digital rectal exam (DRE) or urology referral if clinically indicated
• Routine follow-up appointments at provider's discretion based on clinical stability

I understand that failure to complete required labs may result in modification, suspension, or discontinuation of treatment, and refills will not be issued if monitoring labs are overdue, incomplete, or significantly abnormal.

Fertility Considerations & Fertility-Preservation Pathway

Health Maintenance Responsibilities

I acknowledge that:

• Navara Health is not my primary care provider unless I have separately enrolled in the Direct Primary Care (DPC) program
• I am responsible for maintaining a relationship with a primary care provider and obtaining age-appropriate health screenings, including:
  • Digital rectal exam (DRE) and prostate evaluation
  • Colonoscopy at appropriate ages
  • Cardiovascular evaluation (lipids, blood pressure, ECG if indicated)
  • Screening for metabolic or endocrine disorders
  • Dermatologic skin checks
  • Vision and dental care
• I will provide all abnormal findings from outside providers to Navara Health
• I will not hold Navara Health liable for general health maintenance outside the scope of hormone therapy

Treatment Authorization & Voluntary Election

I have been informed of the recommended baseline workup, including laboratory testing, age-appropriate cancer screenings, and cardiovascular risk assessment, and of the importance of completing these before initiating testosterone therapy.

If I voluntarily elect to begin testosterone therapy before completing all age-appropriate screenings (such as colonoscopy, DRE, cardiac stress testing, or specialist evaluations) recommended for my age and risk profile, I do so knowingly and voluntarily, and I release:

• Navara Health, PLLC
• Jessica Boggs, MSN, APRN, FNP-C, ENP-C
• The medical director and all associated providers, nurses, contractors, and staff

from liability relating to:

• Cardiovascular events occurring during or after therapy
• Prostate, testicular, colon, or breast cancer detected during or after therapy
• Thromboembolic events
• Any other medical condition not directly caused by improper administration of therapy

Patient Obligations & Representations

I agree to:

• Take medication exactly as prescribed
• Not change dose, frequency, or route without provider approval
• Maintain follow-up appointments and complete required labs
• Disclose all medications, supplements, hormones, and prior or current testosterone use from any source
• Disclose any new diagnosis, hospitalization, or significant medical event during therapy
• Maintain care with a PCP or specialist as outlined in Section 10
• Acknowledge that TRT may be considered experimental, unnecessary, or controversial by other physicians, and that opinions on TRT for age-related symptoms vary within the medical community
• Comply with the separate Testosterone Therapy Controlled Substance Agreement, including PMP monitoring, secure storage, and prohibition on diversion or sharing
• Follow the topical testosterone transfer precautions in Section 6 if prescribed a topical formulation

Communication & HIPAA Authorization

I authorize Navara Health to communicate with me regarding scheduling, prescription management, lab results, monitoring, and follow-up through:

• The secure HIPAA-compliant patient portal
• Email to the address I have provided
• SMS / text message to the mobile number I have provided
• Telephone calls to the number I have provided

I understand that email and SMS are not fully secure channels. I may revoke authorization for any specific channel in writing to contact@navarahealthtx.com, except where required for legally mandated notices.

Indemnification & Assumption of Risk

Dispute Resolution & Binding Arbitration

Any dispute, controversy, or claim arising out of or relating to this Consent, the prescribing of testosterone therapy, or the practitioner-patient relationship — including any claim of medical malpractice, billing dispute, or breach of contract — shall first be addressed by good-faith negotiation between the parties.

If the matter cannot be resolved through negotiation within thirty (30) days, the parties agree to submit the dispute to binding arbitration administered by a recognized arbitration body (such as the American Arbitration Association) under its applicable rules, with the arbitration to take place in Dallas County, Texas.

The parties acknowledge that by agreeing to arbitration, they are waiving the right to a jury trial. This provision does not waive any right that cannot lawfully be waived under Texas law. Either party retains the right to seek injunctive or equitable relief in court where appropriate.

Governing Law & Severability

This Consent shall be governed by and construed under the laws of the State of Texas. If any provision is found unenforceable, the remaining provisions shall remain in full force and effect.

Emergency & Adverse Event Reporting

Non-emergent adverse events should be reported to Navara Health through the patient portal or by calling 469-653-3124. Suspected drug-related adverse events may also be reported to the FDA MedWatch program at 1-800-FDA-1088 or fda.gov/medwatch.