NAVARA HEALTH
Functional · Hormonal · Aesthetic · Integrative
Women's BHRT · Clinical Informed Consent

Women's Hormone Optimization
Clinical Informed Consent

Perimenopause · Menopause · Postmenopause · BHRT
Practice
Navara Health, PLLC
5301 Alpha Road, Suite 34, Room 21
Dallas, Texas 75240
Contact
469-653-3124
contact@navarahealthtx.com
Prescribing Provider
Jessica Boggs, MSN, APRN, FNP-C, ENP-C
Medical Director
Simal Patel, MD
Telehealth Service States (Adults 18+)
Texas Colorado Connecticut Florida Iowa Oklahoma Vermont Virginia Washington

Purpose & Document Stack

This document is the clinical informed consent for evaluation and treatment with Women's Bioidentical Hormone Replacement Therapy (BHRT) and adjunctive hormone optimization at Navara Health, PLLC. It addresses the clinical nature, risks, benefits, alternatives, monitoring requirements, fertility/pregnancy considerations, and patient responsibilities specific to women's hormone therapy.

Two-Document Women's BHRT Consent Stack. Initiating women's hormone therapy at Navara Health requires:
  1. Hormone Optimization Program Membership Consent — establishes the membership relationship, program structure, and broad clinical framework
  2. This Women's Hormone Optimization Clinical Informed Consent — deep clinical risk and treatment acknowledgment
Both documents are incorporated by reference into each other. Compounded medications additionally require signature of the Compounding Pharmacy Authorization & Informed Consent.

Nature of Treatment

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

The Menopausal Continuum

Hormonal changes occur along a continuum, and the most appropriate treatment depends on where I am in that continuum:

Perimenopause

The transition period before menopause, often beginning in the 40s. Cycles become irregular; estrogen and progesterone fluctuate. Symptoms may include sleep disturbance, mood changes, hot flashes, and irregular bleeding.

Menopause

Defined as 12 consecutive months without a menstrual period. Average age in U.S. is 51. Estrogen and progesterone fall significantly; hot flashes, sleep, mood, vaginal, and cognitive symptoms may intensify.

Postmenopause

The years after final menstrual period. Long-term considerations include bone health, cardiovascular health, genitourinary symptoms, and cognitive concerns. The "timing hypothesis" applies (see Section 5).

Treatment May Involve

Off-Label Use Acknowledgment

I acknowledge that:

Alternatives to Treatment

I have been informed of the following alternatives:

I understand these alternatives and voluntarily choose to proceed with the treatment plan recommended by Navara Health.

Route of Administration & Risk Differential

The route by which estrogen is delivered substantially affects its risk profile. Estrogen taken by mouth undergoes "first-pass" metabolism through the liver, which increases production of clotting factors and inflammatory markers. Estrogen delivered through the skin (transdermal patch, gel, or cream) or vaginally bypasses first-pass hepatic metabolism and carries a lower clotting and cardiovascular risk profile.

Lower Risk Profile
Transdermal Estrogen

Patch, gel, cream, or spray. Bypasses first-pass hepatic metabolism. Lower risk of VTE (deep vein thrombosis, pulmonary embolism), stroke, and gallbladder disease compared to oral. Navara Health's preferred default route for systemic estrogen.

Higher Risk Profile
Oral Estrogen

Tablet taken by mouth. Undergoes hepatic first-pass metabolism. Associated with approximately 2× the VTE risk of transdermal estrogen and increased gallbladder disease risk. Selected only when transdermal options are not appropriate.

I understand that I will discuss route preferences with my provider and that route selection may be modified based on my risk profile, lab response, and tolerance.

FDA, Evidence Framing & The Women's Health Initiative

Evidence Disclosure · The WHI Era & Modern Reanalysis

The Women's Health Initiative (WHI), published in 2002, raised concerns about hormone therapy by reporting increases in breast cancer, cardiovascular events, and stroke in women taking conjugated equine estrogens (CEE) plus medroxyprogesterone acetate (MPA). The WHI's findings led to a dramatic decline in hormone therapy use globally.

However, modern reanalysis of WHI data and subsequent large studies have significantly clarified the picture. The risks identified in WHI:

The North American Menopause Society (NAMS), the International Menopause Society (IMS), and the Endocrine Society have all updated their position statements to reflect that hormone therapy is generally safe and effective for healthy symptomatic women under age 60 or within 10 years of menopause, with risk increasing in older or more remote populations.

I understand that:

Off-Label Testosterone Use in Women

Off-Label Clinical Disclosure

Testosterone Therapy in Women

There is no FDA-approved testosterone product specifically indicated for women in the United States. All testosterone prescribed to women is therefore off-label. International clinical guidelines support its judicious use:

The Global Consensus Position Statement on the Use of Testosterone Therapy for Women (2019), endorsed by major international menopause and endocrine societies, supports testosterone therapy for women with diagnosed hypoactive sexual desire disorder (HSDD) after appropriate evaluation. The position statement recognizes that:

Navara Health prescribes testosterone in women at physiologic doses based on symptoms, labs, and clinical response. At Navara, women's testosterone is delivered via subcutaneous or intramuscular injection (cypionate or enanthate) or compounded topical cream. Supraphysiologic dosing is not provided.

Clinical Risks & Side Effects

Common
Generally Mild & Manageable
Breast tenderness, swelling, or fullness. Spotting, breakthrough bleeding, or menstrual changes. Fluid retention or bloating. Mood changes (often related to dose, balance, or progesterone metabolism). Headaches or migraine pattern changes. Nausea (more common with oral estrogen). Injection-site reactions (with testosterone injection). Application-site irritation (with topical formulations). Sleep changes (often initially, especially with progesterone).
Possible — With Androgen Therapy
Testosterone-Related Effects
Acne or oily skin. Mild facial or body hair growth (hirsutism). Voice deepening (rare; usually only with supraphysiologic dosing — Navara aims to maintain physiologic ranges; voice changes may be irreversible). Clitoral sensitivity changes or enlargement. Lipid changes. Mood changes including increased assertiveness or irritability. Mild elevation in red blood cell count is uncommon at female-physiologic doses but is monitored.
Possible — Estrogen / Progesterone
Hormone-Related Effects
Worsening of ovarian cysts, uterine fibroids, endometriosis, or fibrocystic breast changes. Endometrial thickening (in women with a uterus — progesterone is co-prescribed to mitigate). Migraine with aura (caution). Mood symptoms with progesterone in sensitive patients. Gallbladder symptoms (more common with oral estrogen).
Rare but Serious
Significant Risks of Women's HRT
Venous thromboembolism (VTE) — deep vein thrombosis (DVT), pulmonary embolism (PE). Higher with oral than transdermal estrogen. Stroke — risk varies by route, age, and timing. Cardiovascular events — risk varies substantially by timing of initiation relative to menopause, route, and individual factors. Breast cancer — combined long-term estrogen + progestin therapy may modestly increase breast cancer risk in some populations; risk depends on formulation, duration, age at initiation, and personal/family history. Estrogen alone (in women without a uterus) has different risk profile. Endometrial hyperplasia or carcinoma — risk in women with a uterus receiving unopposed estrogen; progesterone is co-prescribed to mitigate. Gallbladder disease — primarily oral estrogen. Severe allergic reaction or anaphylaxis. Unforeseen long-term effects — long-term safety data for compounded bioidentical hormone optimization remains an area of ongoing research.

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

Genitourinary Syndrome of Menopause (GSM)

Local Vaginal Therapy for GSM

Genitourinary Syndrome of Menopause (GSM) includes vaginal dryness, vulvovaginal atrophy, painful intercourse (dyspareunia), urinary urgency, recurrent urinary tract infections, and other genitourinary symptoms. These symptoms result from declining estrogen levels affecting the vaginal, vulvar, and lower urinary tract tissues.

Local (vaginal) estrogen is highly effective for GSM and has a substantially different risk profile than systemic estrogen:

I understand that local vaginal estrogen may be prescribed alone or in conjunction with systemic hormone therapy.

Topical Hormone Transfer Precautions

I understand and agree that:

Pregnancy, Fertility & Contraception

I understand and agree that:

Potential Benefits (Not Guaranteed)

Individual responses vary, and no specific outcome is guaranteed. Potential benefits described in clinical literature include:

Contraindications & Cautions

Absolute Contraindications

Relative Contraindications & Cautions

Monitoring Requirements

Baseline Laboratory Panel (Prior to Initiation)

Monitoring Cadence

Required Age-Appropriate Screening (Coordinated With PCP / Gynecologist)

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

Health Maintenance Responsibilities

I acknowledge that:

Treatment Authorization & Voluntary Election

I have been informed of the recommended baseline workup, including laboratory testing, mammogram (age-appropriate), pelvic exam/PAP, breast examination, and cardiovascular risk assessment, and of the importance of completing these before initiating hormone therapy.

If I voluntarily elect to begin hormone therapy before completing all age-appropriate screenings (such as overdue mammogram, PAP, colonoscopy, DEXA, or specialist evaluations) recommended for my age and risk profile, I do so knowingly and voluntarily, and I release:

from liability relating to:

Note: This voluntary election does not waive the requirement for baseline BHRT-specific laboratory monitoring (hormone panel, CBC, CMP, lipids, thyroid, etc.). Baseline BHRT labs are a clinical safety requirement and cannot be deferred. This election applies only to broader age-appropriate health screenings such as overdue mammogram, colonoscopy, DEXA, or specialist evaluations.

Patient Obligations & Representations

I agree to:

Communication & HIPAA Authorization

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

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.

Indemnification & Assumption of Risk

Indemnification Agreement

I agree to indemnify, defend, and hold harmless:

from any and all claims, damages, liabilities, costs, and expenses (including reasonable attorneys' fees) resulting from:

I accept full responsibility for my decision to undergo hormone therapy.

This indemnification does not apply to cases of gross negligence or willful misconduct, and does not waive any right that cannot lawfully be waived under the laws of the State of Texas.

Dispute Resolution & Binding Arbitration

Any dispute, controversy, or claim arising out of or relating to this Consent, the prescribing of hormone 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, unless otherwise required by the laws of the patient's state of residence.

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 the patient's state 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, except where the laws of the patient's state of residence require otherwise. If any provision is found unenforceable, the remaining provisions shall remain in full force and effect.

Emergency & Adverse Event Reporting

For Emergencies, Call 911

Call 911 or go to the nearest emergency room for:

For mental health crises, call or text 988 (Suicide & Crisis Lifeline).

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.

Patient Initials — Required for Each Critical Clause

Each of the following requires my separate written initials.
I understand that compounded bioidentical hormones are not FDA-approved as finished drug products, and that testosterone use in women is off-label, with international clinical guideline support described in Section 6.
Initials
I understand the route of estrogen administration significantly affects risk, with oral estrogen carrying approximately 2× the VTE risk of transdermal estrogen.
Initials
I understand the WHI study and the evolution of evidence regarding HRT safety, including the "timing hypothesis" / window-of-opportunity concept described in Section 5.
Initials
I understand the risks of breast cancer, VTE, stroke, cardiovascular events, and endometrial effects described in Section 7.
Initials
If prescribed topical hormones, I understand the transfer risk to partners, children, and pets, and I will follow the precautions in Section 9.
Initials (if applicable)
I understand pregnancy considerations in Section 10, including that HRT is not a contraceptive and that I must notify Navara immediately if pregnant.
Initials
I understand required lab monitoring (baseline, quarterly during titration, annually once optimized) is a condition of continued therapy.
Initials
I understand that Navara Health is not my primary care provider, and I am responsible for maintaining age-appropriate screening (mammogram, PAP, colonoscopy, DEXA) with my PCP or gynecologist.
Initials
If I am voluntarily electing to begin therapy before completing all recommended age-appropriate screenings, I understand and accept the release of liability in Section 15 and the indemnification in Section 18.
Initials
I understand this consent operates alongside the Hormone Optimization Membership Consent and the Compounding Pharmacy Authorization where compounded medications are prescribed.
Initials
I agree to binding arbitration as described in Section 19 and understand that I am waiving the right to a jury trial.
Initials

Consent & Electronic Authorization

By signing below (or by typing my full legal name as an electronic signature), I acknowledge and affirm:

Patient Printed Name
Date of Birth
Menopausal Status (Peri / Meno / Post)
Hysterectomy Status (Yes/No; if yes, oophorectomy?)
Patient Signature (or Typed Electronic Signature)
Date
Provider Signature — Jessica Boggs, APRN, FNP-C, ENP-C
Date
NAVARA HEALTH, PLLC · 5301 ALPHA ROAD STE 34 RM 21 · DALLAS, TX 75240 · 469-653-3124 · CONTACT@NAVARAHEALTHTX.COM
Document version: May 2026 · Women's Hormone Optimization Clinical Informed Consent
Companion Documents: Hormone Optimization Membership Consent · Compounding Pharmacy Authorization