Consent for Menopausal Hormone Therapy (MHT) and Testosterone Therapy for Women
**Attached at the bottom is the most current re-review of the Women’s Health Initiative (1998) findings and updated guidelines (2024-2025) for women starting hormone therapy.
Cost of Treatment
For Weight Loss Wellbeing Medical members, the add-on monthly fee is $25/month which covers the medical provider care, management, lab interpretation, and treatment plans.
For patients only interested in hormones, the monthly recurring fee is $49/month.
Initial blood serum based labs may be requested prior to initiating treatment at the cost of the individual. You will have the option to use your insurance or pay a self-pay rate.
I understand that my provider may recommend advanced hormone testing using DUTCH (Dried Urine Test for Comprehensive Hormones) hormone metabolite testing, which is considered a highly accurate and safe method for assessing hormone levels and metabolism. I understand that the cost of this test will be offered to me at wholesale pricing (approximately $300) and is not typically covered by insurance.
I understand that I receive all medications at wholesale prices, and depending on the medication formulation, I may be able to use my insurance to help cover the costs. All compounded formulations (such as testosterone or compound creams) will be out-of-pocket cost. You are entitled to ask for estimation of medication costs prior to committing to join the program.
I understand that this testing may be performed prior to initiating hormone therapy upon my request, but is more commonly recommended approximately six months after starting treatment to assess hormone levels, metabolism, and therapeutic response.
You may discontinue the hormone program at any time by notifying your medical provider or assistant in writing.
You may discontinue the hormone program at any time by notifying your medical provider or assistant in writing. This will terminate the hormone prescribing and management relationship.
Purpose of Treatment
Hormone Replacement therapy (HRT) or menopausal hormone therapy (MHT) is used to treat symptoms related to perimenopause, menopause and estrogen deficiency. These may include vasomotor symptoms (hot flashes and night sweats), sleep disruption related to peri/menopause, genitourinary syndrome of menopause (vaginal itching, dryness, pain with intercourse, or frequent or recurring UTIs and vaginal infections), and prevention of bone loss in appropriate candidates. Testosterone therapy may be considered in select postmenopausal women for hypoactive sexual desire disorder (aka low libido) after appropriate evaluation.
Menopausal hormone therapy is the most effective treatment for vasomotor symptoms. It is not prescribed for the primary prevention of cardiovascular disease, dementia, or other chronic conditions.
Hormone Therapy Options Reviewed
Estrogen Therapy
Systemic estrogen options include:
Transdermal estrogen (patches, gels, sprays) - first line
Oral estrogen - second line
Local vaginal estrogen cream only does not absorb systemically and does not need opposing progesterone to protect endometrium.
Progesterone / Progestogen Therapy
In individuals with an intact uterus, progesterone or a progestogen is required when systemic estrogen is used to reduce the risk of endometrial hyperplasia and endometrial cancer.
Options include:
Oral micronized progesterone - first line
Synthetic progestins - will not be used in this practice
Levonorgestrel-releasing intrauterine device (IUD) in select cases
Testosterone Therapy
Testosterone therapy for women is supported by evidence only for the treatment of hypoactive sexual desire disorder in postmenopausal women after appropriate evaluation. Testosterone is not approved for general use for energy, mood, weight loss, or overall vitality.
When used, therapy should aim to maintain testosterone levels within the normal physiologic female range.
Chosen and Preferred Treatment Regimen
After discussion of available options, benefits, risks, and alternatives, the preferred regimen consists of:
Transdermal estradiol patch, 0.05 mg/day, applied twice weekly
Oral micronized progesterone for endometrial protection, sleep, and anxiety improvement
Topical (transdermal) testosterone, only when clinically indicated and appropriately monitored
Rationale for This Regimen
Transdermal Estradiol
Transdermal estradiol avoids first-pass metabolism in the liver and has been associated in multiple studies with a lower risk of venous blood clots and less impact on clotting factors compared with oral estrogen. This route is generally considered safer for individuals with cardiovascular or thrombotic risk factors, though no therapy is risk-free. The dose given through patch is low and will not induce menstrual cycling or interfere with current cycling. It provides a baseline estrogen level to prevent the low dips of estrogen levels which help control the hot flashes and mood swings.
Oral Micronized Progesterone
Oral micronized progesterone (generic Prometrium) is an effective option for endometrial protection when used with systemic estrogen. Some observational data suggest potential differences in breast cancer risk between micronized progesterone and certain synthetic progestins, though evidence is not uniform and ongoing research continues. **Levonorgestrel-releasing intrauterine device (IUD) releases enough progestin into the body to protect the uterus, however, if you would like symptomatic relief then an oral progesterone can also be added.
Topical Testosterone
Topical testosterone allows for lower, more physiologic dosing and is preferred over oral or injectable forms to minimize adverse metabolic effects. Use is limited to appropriate indications and requires ongoing monitoring.
Expected Benefits
Potential benefits of menopausal hormone therapy include:
Reduction in hot flashes and night sweats
Improvement in sleep disruption related to menopause
Improvement in genitourinary symptoms when systemic therapy is indicated
Prevention of bone loss and reduction in fracture risk while therapy is continued
For appropriately selected patients with hypoactive sexual desire disorder, testosterone therapy may improve sexual desire and reduce associated distress.
Risks and Side Effects
Estrogen-Related Risks
Risks of systemic estrogen therapy may include:
Venous thromboembolism (blood clots) - risk is very low with estrogen patch
Stroke - risk is very low with estrogen patch
Gallbladder disease
Breast cancer risk, particularly when estrogen is combined with synthetic progestogens and used long-term (Only bioidentical progesterone is used in this practice)
Endometrial cancer when estrogen is used without adequate progesterone in individuals with a uterus (Progesterone is always prescribed with Estogen, especially in those with a uterus, except for vaginal only estrogen)
Common side effects may include breast tenderness, nausea, headaches, skin irritation at patch sites, and irregular bleeding.
Progesterone-Related Risks
Potential side effects include:
Sedation or drowsiness (more common with oral micronized progesterone) - dose can be adjusted if this occurs.
Mood changes - if you are under high stress, supplementing with progesterone can sometimes make anxiety or stress worse. It is best to work with your medical provider to help reduce stress before or during your HRT.
Bloating
It can occur in 10-15% of people but can be dependent on dosing, timing, and frequency of dose. A continuous low dose is started (100mg nightly). The bloating can be due to slower motility transit, so if you are not already taking magnesium I would add magnesium glycinate (200-300mg) to your nightly routine. In rare cases, it can cause fluid shifts, but the body typically adjusts.
Breast tenderness
Irregular or breakthrough bleeding
Inadequate progesterone exposure increases the risk of endometrial hyperplasia and cancer. (This likely will not happen with oral progesterone, however, it is recommended to complete a DUTCH hormone metabolite panel 6 months after starting treatment to look at absorption).
Testosterone-Related Risks
Potential risks and side effects of testosterone therapy include:
Acne and oily skin
Unwanted facial or body hair growth
Scalp hair thinning
Voice deepening (may be irreversible)
Clitoral enlargement (rare with physiologic dosing)
Mood changes
It is recommended to complete a DUTCH hormone metabolite panel to evaluate your testosterone metabolism pathways. If you favor the DHT pathway genetically, this can cause the above symptoms. We can test this prior to starting testosterone therapy as well as 6 months after. There are DHT pathway blocking medications such as spironolactone (under 50 years) or dutasteride (over 50 years).
Long-term safety data for testosterone use in women are more limited than for estrogen therapy. Therapy requires careful dosing and monitoring.
Updated Evidence and Regulatory Considerations
Recent regulatory updates have clarified that menopausal hormone therapy should be evaluated based on formulation, dose, route of administration, and patient-specific risk factors rather than generalized class warnings. However, systemic estrogen therapy retains warnings related to endometrial cancer risk when used without progesterone in patients with a uterus.
These updates do not eliminate risk and do not apply uniformly to all individuals.
Individuals Who Should Use Caution
Menopausal hormone therapy should be used cautiously and individualized in patients with:
Prior blood clots or known clotting disorders
Migraine with aura
High cardiovascular risk
Uncontrolled hypertension or diabetes with vascular disease
High breast cancer risk
Liver disease
Unexplained vaginal bleeding
Testosterone therapy requires additional caution in individuals with cardiovascular risk factors, lipid abnormalities, or a history of hormone-sensitive conditions.
Contraindications
Systemic estrogen therapy is generally contraindicated in individuals with:
Known or suspected breast cancer
Estrogen-dependent malignancy
Undiagnosed abnormal genital bleeding
Active or prior venous blood clot or arterial thrombotic disease
Severe liver disease
Pregnancy
Testosterone therapy is contraindicated in:
Pregnancy or breastfeeding
Known androgen-sensitive malignancies without specialist involvement
Use of supraphysiologic dosing
Hypersensitivity to formulation components
Monitoring and Follow-Up
Ongoing monitoring is required and may include:
Regular assessment of symptom response (every 6 months at a minimum) and side effects
Blood pressure and cardiovascular risk evaluation, this is self-reported during evaluation
Breast cancer screening per guidelines, patients must continue their annual mammograms with primary care or OBGYN provider
Prompt evaluation of any abnormal vaginal bleeding
For testosterone therapy, periodic monitoring of testosterone levels and assessment for androgenic side effects
Therapy may be adjusted or discontinued based on benefit, risk, and patient preference.
Acknowledgment
I acknowledge that I have been informed of the benefits, risks, alternatives, and uncertainties associated with menopausal hormone therapy and testosterone therapy. I understand that no therapy is without risk and that treatment decisions are individualized. I consent to treatment as outlined above and agree to appropriate monitoring and follow-up.
Summary of Recent Reviews of the Women’s Health Initiative (WHI) Data (2024–2025)
Recent reviews and reinterpretations of the Women’s Health Initiative (WHI) data—now approximately 30 years from study initiation—have led to a significant shift in how menopausal hormone therapy (HT) is understood and applied in clinical care.
Original Purpose and Core Findings
The WHI was designed to evaluate whether hormone therapy could prevent chronic diseases such as heart disease, stroke, dementia, and cancer in postmenopausal women. The original conclusions remain valid: hormone therapy is not recommended for the primary prevention of chronic disease, particularly in older postmenopausal women.
However, newer analyses emphasize that this was never the appropriate population or goal for evaluating hormone therapy’s role in treating menopausal symptoms.
Importance of Age and Timing
A key insight from recent WHI reviews is the importance of age at initiation and time since menopause:
The average age of women enrolled in the WHI was in the mid-60s, well beyond the typical age at which hormone therapy is initiated for menopausal symptoms.
When WHI data are reanalyzed by age and timing, women under age 60 or within 10 years of menopause onset show lower risks and more favorable benefit–risk profiles compared with older participants.
These findings support the concept that hormone therapy is safer and more effective when started earlier in menopause, particularly for symptom relief.
Hormone Therapy for Menopausal Symptoms
The WHI data continue to confirm that hormone therapy is the most effective treatment for vasomotor symptoms, such as hot flashes and night sweats.
For many symptomatic women under age 60 in early menopause, the benefits of hormone therapy outweigh the risks when appropriately selected and monitored.
Estrogen-alone therapy (used in women without a uterus) showed particularly favorable outcomes in symptom relief.
Cardiovascular Risk Reassessment
Earlier concerns about cardiovascular risk have been refined:
Newer analyses suggest that women in their 50s who initiate hormone therapy do not experience increased risk of heart disease, stroke, or heart attack.
Some analyses suggest a potential cardiovascular benefit when therapy is started early, though hormone therapy is still not prescribed for cardiovascular prevention.
Breast Cancer Findings
Breast cancer outcomes vary by regimen:
The combined estrogen–progestin arm of the WHI showed a small increase in breast cancer risk, but the absolute risk increase was low, and breast cancer mortality was not increased.
In contrast, the estrogen-only arm showed a reduced risk of breast cancer.
These findings underscore the importance of hormone formulation, duration of use, and individual risk factors.
Duration and Discontinuation
Long-term follow-up data suggest that:
The benefits of hormone therapy diminish after discontinuation.
This supports the current approach of using the lowest effective dose for the shortest duration needed to manage symptoms, particularly when initiated earlier in menopause.
Calcium and Vitamin D
WHI findings also clarified that:
Calcium and vitamin D supplementation are not effective as universal fracture-prevention strategies in all postmenopausal women.
Supplements are best used to address dietary deficiencies, rather than as blanket recommendations.
Overall Updated Interpretation
The WHI provided essential foundational data, but modern reinterpretation emphasizes that its findings were misapplied too broadly in the past. Current understanding recognizes that:
Hormone therapy is not a preventive treatment for chronic disease.
For many women in early menopause, particularly those under age 60 with bothersome symptoms, hormone therapy offers meaningful benefit with acceptable risk.
Treatment decisions should be individualized, taking into account age, time since menopause, symptom severity, health history, and patient preferences.
Shared decision-making between patient and clinician is essential.
Bottom Line
Recent WHI reviews represent a major shift away from earlier blanket warnings and toward personalized, evidence-based care, acknowledging that for appropriately selected women in early menopause, hormone therapy remains a safe and effective option for symptom relief.
