Oral Micronized Progesterone

This treatment plan reviews the risks and benefits of the treatment we are recommending. Please make sure to read it and the manufacturer's pamphlet that comes with the medicine. The manufacturer's pamphlet contains full information on potential medication interactions, side effects, and other important information you should know about the medicine before you start.

Instructions

You have stated that you wish to obtain hormonal replacement therapy treatment with oral micronized progesterone. Please follow the directions on your prescription for administration of treatment.

Cyclical Dosage Administration: Take 1 capsule by mouth nightly for 12 days before expected menses onset, then off for the remainder of the 30-day cycle. This will cause an expected period-like "withdrawal bleed" every month that should be lighter than a typical period and predictable. If your cycles are irregular you may start the progesterone at any time.

Daily Dosage Administration: Take 1 capsule by mouth nightly.

Black Box Warnings: Hormone therapy contains Black Box Warnings posted by the manufacturer and based off of research, primarily from the Women’s Health Initiative (WHI). Below you will find the Black Box warnings with additional information on current updated research performed after the Women’s Health Study related to the Black Box Warning. Please reach out to your Wisp provider with further questions.

Increased risk for cardiovascular disorders

• The Women’s Health Initiative Study reported increased risks of deep vein thrombosis, pulmonary embolism, stroke, and heart attacks in postmenopausal women (50-79 years of age) during 5.6 yeast of treatment with daily oral conjugated estrogens combined with Medroxyprogesterone Acetate relative to placebo.

Research after the Women’s Health Initiative:

• What we know now suggests that the age at which hormone therapy is started plays a critical role in determining cardiovascular risk as well as the type of hormone being used.
• The WHI used specific formulations of estrogen (conjugated equine estrogen) and progestins (medroxyprogesterone acetate) that have different risk profiles compared to newer and alternative hormone therapies like transdermal estrogen and micronized progesterone.
• Subsequent analyses of the WHI and other studies support the timing hypothesis, which suggests that starting hormone therapy in younger postmenopausal women (closer to the onset of menopause) carries a lower risk and may even have some cardiovascular benefits. The increased risks of stroke and heart attacks are much lower when HT is initiated within 10 years of menopause. You can read more about these studies here and here.

Increased probably risk of dementia

• The WHI Memory Study (WHIMS) showed estrogen plus progestin reported an increased risk of developing probable dementia in postmenopausal women of 65 years and older during 4 years of treatment with daily conjugated equine estrogen and medroxyprogesterone acetate compared to placebo.

Research after the WHIMS study:

• Newly published research shows that taking estrogen and progesterone taken together in mid-life can lower the rate of future dementia by up to 23%. Taking estrogen with or without progesterone later in life does not show an impact on lowering the rate of dementia. These initial findings are very promising and there is more research under way.

Increased risk for breast cancer

• The WHI Study demonstrated taking combined estrogen-progestin therapy had a 26% higher relative risk of developing invasive breast cancer compared to women not on hormone therapy. There was no significant increase in breast cancer risk when taking estrogen alone.

Research after the Women’s Health Initiative:

• Relative Risk: The percentage of increase when comparing two groups
• Absolute Risk: The actual number of additional cases in a given population

While the WHI findings did note a 26% relative increase risk in breast cancer, the absolute risk was an additional 8 cases per 10,000 women annually. Additionally, the women included in the studies average age was 63 which does not reflect the risk for younger women who start on hormone therapy earlier and closer to menopause.

Similarly in the risk section above, newer formulations are now being used that are not showing the same risks as the formularies used in the WHI. You can read more about the breast cancer risk in bioidentical formulations here and here.

When will I experience relief of my symptoms?

• When starting hormone replacement therapy (HRT), many patients begin to notice symptom relief of hot flashes, night sweats, mood changes, and sleep disturbance within a few weeks, although it can take up to 12 weeks for the full benefits to be felt. It’s important to keep in touch with your Wisp provider for any concerning symptoms and sharing your current symptoms on your follow ups for any adjustments needed to your treatment plan. Remember, each person's experience with HRT can vary, so patience is key!
  
  

Allergies

This medicine, like all medications, may cause an allergic reaction if you are allergic to similar medicines or components. If you are allergic to any of the following please do not take the medicine and call or message us or see your doctor in person.

• Peanut oil
• Micronized progesterone
• Hypersensitivity to progesterone
  
  

Conditions

We have evaluated your health history and the specific health information you provided us, however if anything changes and you develop one of these conditions, please stop taking this medicine and call or message us immediately.

• Pregnancy
• Breastfeeding
• Abnormal vaginal bleeding
• History of a blood clot
• Blood clotting disorder
• History of breast, ovarian, uterine, or endometrial cancers
• History of a heart attack
• History of cardiac disease
• History of a stroke or TIA
• Abnormal or concerning mammogram results
• History of Metastatic Melanoma
• Liver Disease (not including non-alcoholic fatty liver)
• Upcoming surgery in 4-6 weeks
  
  

Pregnancy and Breastfeeding

Hormonal therapy is not intended for use during pregnancy. Based on available data, increased risks of birth defects have not been observed following maternal use.

Progesterone is present in breastmilk, but levels are low. Studies indicate that progesterone is not detrimental to milk production or duration of nursing. No special precautions are required.

Medicines, Supplements, and Foods

We have evaluated the specific health information you provided us, however if you are taking any of the medicines, foods, or supplements listed below call or message us before you take the medicine. Some of these can cause dangerous interactions with the medicine we are prescribing you and we will help you evaluate that risk and decide on an appropriate treatment plan. Please ensure your chart is up to date with your current medications, allergies, and medical conditions so your provider can safely treat you as this list may not be all inclusive.

• Additional hormonal treatment
• Thyroid medications- check levels more frequently
• Certain herbal medications and supplements that may impact hormones
  
  

Emergency Side Effects

This medicine can cause dangerous and potentially life-threatening side effects. If any of the emergency side effects listed in the manufacturer’s pamphlet or those below happen to you please stop taking the medicine and call 911 or seek immediate medical help in person. This list may not be all inclusive.

• Sudden onset of chest pain
• Shortness of breath
• Difficulty or painful swallowing
• Severe skin rash and/or itching
• Facial or throat swelling
• Blurred vision
• Severe bloody diarrhea
• Suicidal ideation
  
  

Other Side Effects

This medicine can also cause other side effects including (list is not all inclusive):

• Swelling
• Abdominal discomfort, cramping, or bloating
• Changes in menstrual flow and duration
• Vaginal discharge
• Breast tenderness or discomfort
• Headache
• Dizziness
• Fatigue
• Mood changes
• GI discomfort: constipation, diarrhea, nausea, vomiting
• Acne
• Change in libido
• Increased urinary symptoms
  
  

Risks

Accurate Information

We have evaluated your health history and your specific health information you provided and determined it is safe to proceed with this treatment at this time. If your health history changes including diagnoses or medications please message or call us before you take the medicine to ensure it's safe to proceed. Some medications and conditions can cause dangerous interactions with the medicine we are prescribing and we will help you evaluate that risk and decide on an appropriate treatment plan.

Treatment Failure

This treatment is not guaranteed to be effective. It may not work or may only partially resolve the condition for which you are seeking treatment. If the treatment is not working, or if you are experiencing new or worsening symptoms, give us a call or message us anytime. If it is an emergency, call 911 or seek immediate medical help in person. You may need to seek alternative treatment such as those listed below or in the follow up plan.

Misdiagnosis or Delayed Diagnosis

Through telehealth, there is also a risk that we misdiagnose or fail to diagnose conditions that you may have which could affect our recommendation for treatment. This risk exists with a doctor in person as well but they may have additional resources to aid their evaluation. We use evidence-based practice and guidelines as well as clinical decision-making to minimize these risks.

Accepting or Declining Our Recommendation

We have based our recommendation on your specific case and medical guidelines, but there may be alternative treatments or strategies that may be helpful to you. Some may be more or less effective than what we provide. Some treatments may require an in-person exam or procedure which we can’t provide. Message us or talk to your doctor in person to discuss alternative treatments.

Share with Your In-Person Healthcare Team

You can access your records anytime. We strongly recommend that you update your in-person doctor, pharmacist, and the rest of your healthcare team to let them know about any new medicines you are taking or other changes in your health.

You can also ask us questions anytime and we are happy to help you share any information about your health with your in-person healthcare team.