Male Estradiol Therapy Consent

PURPOSE OF TREATMENT

The patient presents with symptoms and/or risk factors that may benefit from physiologic estrogen therapy. Although estradiol is FDA-approved for use in women, its use in men for cardiometabolic, neurologic, and skeletal protection is considered off-label. 

 

Expected Benefits:

Estradiol is a vital hormone for both men and women. In males, estradiol is synthesized via aromatization of testosterone and plays a critical role in cardiovascular, neurologic, and skeletal health. Optimizing estradiol levels may offer the following benefits:

• Cardiovascular protection: Estradiol may reduce plaque burden in coronary arteries, support healthy vasodilation, and help stabilize vascular endothelium, potentially lowering the risk of atherosclerosis and cardiovascular events.
• Neurologic health: The brain contains the highest density of estrogen receptor sites. Estradiol may support cognitive function, protect against neuroinflammation, and is associated with reduced risk of neurodegenerative conditions, including Alzheimer’s disease.
• Lipid profile improvement: May result in decreased LDL, increased HDL, and reduced triglycerides, supporting improved lipid metabolism and cardiometabolic health.
• Central adiposity: Estradiol therapy may contribute to reduction in waist circumference and visceral fat, especially in men with metabolic syndrome.
• Bone density: Supports bone mineralization, slowing or reversing osteopenia and osteoporosis.
• Mood and cognition: May aid in the improvement of mental clarity, memory, and emotional regulation in patients with estrogen deficiency. 

The desired therapeutic outcomes are clinical: decreased arterial plaque, improvement in lipid profile, reduction in central adiposity, and enhanced cognitive and metabolic function. Treatment is guided by symptoms and response, not by targeting a specific serum estradiol level.

 

Risks and Side Effects:

Potential risks and side effects include:

• Gynecomastia (breast tissue development)
• Nipple tenderness or fullness
• Fluid retention or bloating
• Sexual side effects (changes in libido or erectile function)
• Emotional changes or mood swings

Clotting Risk Clarification

• While Premarin (conjugated equine estrogens) and medroxyprogesterone acetate have been associated with increased risk of thrombotic events, oral bioidentical estradiol has a lower risk profile. Nonetheless, any form of estrogen therapy may carry a theoretical risk of thrombosis, especially in individuals with underlying clotting disorders, sedentary lifestyle, or tobacco use.

 

Risks and Side Effects:

Treatment will consist of oral bioidentical estradiol, compounded to an individualized dose. Follow-up will include symptom tracking, relevant lab markers (including lipid panels and inflammatory markers), and ongoing evaluation of clinical response. Dose adjustments may be made based on patient response and tolerability.

 

Alternatives to Estrogen Replacement Therapy:

You may choose not to undergo estradiol therapy. The following are alternative options that may be considered:

No Treatment: Electing not to pursue estrogen optimization may result in progression of underlying cardiometabolic risk, arterial plaque buildup, cognitive decline, or continued bone demineralization over time.

Conventional Medical Management: Use of prescription medications such as cholesterol-lowering drugs (excluding statins), anti-hypertensives, memory enhancers, or anti-inflammatory agents may be used to manage individual risk factors without directly addressing estradiol deficiency.

Lifestyle Modification: Incorporating structured changes such as improved nutrition, regular exercise, body fat reduction, stress management, sleep optimization, yoga, sauna, or targeted supplementation (e.g., omega-3s, CoQ10) to promote overall cardiometabolic health.

 

Off-Label Use and Informed Consent:

This treatment represents an off-label use of estradiol in a male patient. While not FDA-approved for use in men, there is increasing clinical rationale and literature supporting physiologic estradiol optimization in males who present with:

• Testosterone therapy–induced estrogen suppression
• Atherosclerosis or coronary calcification
• Poor lipid profile or central adiposity
• Cognitive decline or neurodegenerative risk
• Osteopenia or osteoporosis

This protocol is focused on restoring protective estradiol function in the male body, not on achieving feminizing effects. Clinical decisions are made based on patient goals, symptoms, risk factors, and therapeutic response.

Please initial below to acknowledge the following:

I confirm that I have reviewed and understand the potential risks, benefits, alternatives, and the off-label nature of estradiol therapy. I understand this therapy is not FDA-approved for men but may offer significant clinical benefit based on my health history and treatment goals.

AUTHORIZATION

I voluntarily request and give my informed consent for Alexander Medical, LLC and its healthcare providers to initiate or continue estradiol hormone therapy as described.

I authorize the providers to perform any additional tests, evaluations, or procedures reasonably necessary to support my care. I understand that this treatment is elective and that I may stop at any time by informing my provider.

 

ACKNOWLEDGMENT

I have read (or had read to me) this entire consent form. I have had the opportunity to ask questions and all questions have been answered to my satisfaction. I understand the risks, benefits, and alternatives, and I consent to the use of estradiol hormone therapy.