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HORMONE REPLACEMENT THERAPY INFORMED CONSENT

1. PURPOSE

This consent covers HRT including testosterone, estrogen, progesterone, DHEA, and/or pregnenolone, in FDA-approved or compounded formulations. Routes may include IM/SubQ injection, transdermal cream/gel, oral capsules, sublingual troches, or pellet implantation.

2. EXPECTED BENEFITS
  • Improved energy, mood, and cognitive function
  • Improved libido and sexual function
  • Increased muscle mass and bone density (testosterone)
  • Relief from menopausal symptoms (estrogen/progesterone)
  • Improved sleep quality
3. RISKS BY HORMONE

Testosterone:

  • Acne, oily skin, hair changes; polycythemia (requires monitoring); mood changes/irritability; testicular atrophy, reduced sperm (males); voice deepening, clitoral enlargement (females, may be irreversible); cardiovascular risk (monitoring required); liver effects (oral); sleep apnea exacerbation

Estrogen:

  • Breast tenderness, bloating, headaches; increased DVT/PE risk (especially oral); potential breast cancer risk (long-term); endometrial hyperplasia (if without progesterone); mood changes

Progesterone:

  • Drowsiness, dizziness, breast tenderness; mood changes, bloating; breakthrough bleeding

DHEA / Pregnenolone:

  • Acne, hair changes; hormonal imbalance if not monitored; limited long-term safety data
4. MONITORING
  • Baseline: CBC, CMP, lipid panel, hormone panel, PSA (males >40)
  • Every 3-6 months during treatment
  • Annual mammogram (females on estrogen) and DRE/PSA (males on testosterone) per guidelines
5. CONTRAINDICATIONS

Hormone-sensitive cancers; uncontrolled cardiovascular disease/blood clots; pregnancy/breastfeeding; severe liver disease; undiagnosed vaginal bleeding

6. PATIENT ACKNOWLEDGMENTS
  • I understand HRT may involve compounded formulations that are not FDA-approved.
  • I have been informed of risks, benefits, and alternatives.
  • I agree to complete all recommended monitoring.
  • I will report adverse effects including mood changes, vision changes, chest pain, leg swelling, or unusual bleeding immediately.
  • I understand I may withdraw consent at any time.
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