Vaginal estradiol 0.01% is a prescription cream containing plant-derived estrogen used to treat the symptoms of moderate to severe vaginal dryness (e.g. itching and burning) that is the result of the decreased estrogen levels of menopause. For more information on vaginal estradiol see the Prescribers’ Digital Reference (PDR).

Vaginal estradiol is a cream that comes with a calibrated applicator that has markings for 1, 2, 3, or 4 grams. Use the applicator to apply the prescribed amount of cream into the vagina. In order to minimize leakage of the cream, it is best to apply the medication at night before lying down.

Please log in to your Ro account and message your provider. Your provider should be your first point of contact regarding questions about medication efficacy, side effects, and whether or not you would benefit from a change in dose or even a change in medication.

Vaginal estradiol should not be used if any of the following apply: – Undiagnosed abnormal genital bleeding – Known, suspected, or history of cancer of the breast – Known or suspected neoplasia (cancer or abnormal cells) that are affected by estrogen, now or at any time in the past – Any blood clotting problem (e.g. deep vein thrombosis, which is a blood clot in any vein in the body, or pulmonary embolism, which is a blood clot in the lung) now or at any time in the past – Thromboembolic disease (e.g. stroke or heart attack) now or at any time in the past – Known allergy reaction of any severity to estradiol vaginal cream – Known liver disease from any cause or a decrease in liver function – Known protein C, protein S, or antithrombin deficiency or other known disorders that affect blood clotting – Known or suspected pregnancy or breastfeeding

For a full list of contraindications and precautions, see the PDR.

Vaginal estradiol is well tolerated by most patients, but all medications can have side effects. Below are a few potential side effects: – Headache – Back pain – Weight gain – Skin irritation, itching – Diarrhea – Nausea – Abdominal pain – Period cramps, breakthrough bleeding – Pain in the breasts

For a full list of side effects, see the PDR.

Contact your provider if you experience any new symptoms or if your symptoms do not change after two months of using vaginal estradiol for vaginal dryness.

If you believe you are experiencing a medical emergency, call 911.

Introduction

Most women think of menopause only as the time of life when their periods stop; however, menopause is often associated with a variety of other possible changes. The symptoms of menopause and perimenopause can be only minimally uncomfortable—but for some women, the symptoms (e.g. vaginal dryness, pain on intercourse, vaginal infections, itching) can be extremely disturbing.

What is Vaginal Dryness?

Vaginal dryness can occur at any age with sometimes simple causes, like dehydration or use of medications that dry mucus throughout the body (e.g. Sudafed). However, the most bothersome cases of vaginal dryness are associated with the loss of naturally-produced estrogen that accompanies menopause. It is remarkably common and usually occurs along with other symptoms like pain with intercourse, itching, and difficulty with urination. Yeast and other infections can increase as well.

Why is it so common with menopause and perimenopause?

Menopause is defined as the cessation of menstrual cycles that occurs when a woman stops ovulating permanently due to a loss of eggs (ovarian follicles). As part of this process, the ovaries stop producing large amounts of estrogen (and progesterone). It is only diagnosed after a woman has not had a period for 12 months. The average age of menopause in the United States is 51 years old but it is possible to experience it at a much earlier age. About 1% of women will experience menopause before age 40 (premature menopause) and 5% will experience it before age 45.

Perimenopause is defined as the transition from having regular menstrual cycles to the complete cessation of menstrual cycles. It usually begins when a woman who previously had cycles that were regular with a predictable length begins having irregular periods before eventually having no periods at all. Women enter perimenopause on average about 4 years before they stop having periods altogether.

It is in this early period just before menopause when symptoms like vaginal dryness can start to appear. The most common symptom during perimenopause and menopause is hot flashes/flushes, which is estimated to occur in over 75% of women during midlife, but vaginal dryness is also remarkably common.

Subtle changes occur throughout the reproductive system, including the vagina—and unlike hot flashes and other general menopausal symptoms, vaginal changes do not improve with time and often worsen with each passing year. The decreasing levels of estrogen cause the vaginal tissue and the vulvar skin (outer lips of the vagina) of the genitals to become atrophic—meaning the skin begins to lose its normal, thick structure.

The vagina also becomes more susceptible to yeast and other infections. The once healthy balance of organisms that was supported by a slightly acidic, vaginal environment is altered in the less acidic, estrogen-deprived vagina of menopausal women. The term used to describe all the changes that occur in the vagina and vulva is vulvovaginal atrophy (VVA).

Other symptoms related to the loss of estrogen in the genital region include urinary tract symptoms (e.g. frequent urination, a sense of urgency, loss of urine with stress, need to urinate at night) since the skin in the area of the urethra (the tube that carries urine) is affected by the loss of estrogen.

Taken together, symptoms of menopause involving the vaginal tissue and the urinary tract are called the genitourinary syndrome of menopause (GSM). You will often see VVA and GSM clumped together as VVA/GSM. GSM includes all the symptoms that may occur and respond to therapy as described below.

What changes are causing the dryness I feel?

Before perimenopause or menopause, the vagina is usually moist with skin that is pink from abundant blood vessels. There are multiple folds of extra skin and mucus-secreting sebaceous glands that can produce moisture quickly during sexual excitement.

When estrogen is lost, the skin becomes thin, pale, and dry. The vagina narrows and shortens. The opening to the vagina, called the introitus, can narrow, as well—especially when penetrative sex is not practiced. The vaginal skin can become so thin that small breaks in the blood vessels (now far fewer in number) can occur, the once abundant folds of extra skin disappear, and the vagina loses much of its capacity to expand when needed.

The sebaceous glands may remain but they do not function well. The natural lubrication women experience with stimulation is both lessened and delayed.

What might I experience with these changes?

The North American Menopause Society’s (NAMS) position paper on VVA states, “Symptoms…such as lack of lubrication and pain with intercourse, affect 20% to 45% of midlife and older women but only a minority seek help or are offered help by their providers.”

Vaginal dryness is more than a minor inconvenience for many of the women with the condition.

The Vaginal Health: Insights, Views & Attitudes (VIVA) online survey asked women how the vaginal discomfort associated with vaginal dryness affected them. The results were striking:

– 80% considered it to affect their lives negatively – 75% reported negative consequences on their sex life – 68% reported that it makes them feel less sexual – 36% reported that it makes them feel old – 33% reported negative consequences on marriage/relationship – 26% reported a negative effect on self-esteem – 25% reported that it lowers quality of life

Despite the toll it takes, vaginal health is commonly not addressed by healthcare providers during perimenopause and menopause. In the largest survey of US women, Real Women’s Views of Treatment Options for Menopausal Vaginal Changes (REVIVE), only 7% of the 3,047 women in the study reported that their healthcare provider asked them questions about VVA.

The authors of the VIVA survey concluded, “Vaginal atrophy negatively impacts women’s lives, but women lack knowledge of the subject and are hesitant to consult healthcare professionals, who should proactively initiate discussions regarding appropriate treatment options.”

Vaginal dryness is associated with a number of significant symptoms that may be missed unless the question is asked. The REVIVE study reports, “The most common VVA symptoms were dryness (55% of participants), dyspareunia—pain with sex (44%), and irritation (37%). VVA symptoms affected the enjoyment of sex in 59% of participants.” Also, sleep was disturbed in 24% and enjoyment of life diminished in 23%.

Few women knew that their symptoms were associated with menopause and hormone changes. Yet, the personal consequences of unaddressed vaginal dryness are significant. In the REVIVE study:

– 85% of partnered women had some loss of intimacy – 59% indicated symptoms affected their enjoyment of sex – 47% of women with partners said their symptoms interfered with their relationship.

Vaginal dryness and the other vaginal changes associated with menopause are not minor inconveniences for many women. They can be life-altering.

Read carefully all of the material provided, along with the package insert and the information in the Prescribers’ Digital Reference (PDR).

Remember, the plan your Rory-affiliated provider has provided is just one plan for the treatment of vaginal dryness. Reach out to your Rory-affiliated provider if you would like to explore the different plans for the treatment of vaginal dryness offered through Rory or if you have any questions or concerns after reading the information provided here.

Vaginal topical estrogen therapy safety and warnings from the FDA

Before discussing your treatment plan, a review of the information about estrogen and the risks associated with its use is necessary. The U.S. Food and Drug Administration (FDA) requires a boxed warning on estrogen products concerning some serious risks identified in studies when estrogen was given orally. There was an increased risk of breast and endometrial cancer, heart disease, stroke, and dementia, among other findings, and these warnings remain on the use of all estrogens.

The safety of oral estrogen in menopause has been discussed for many years. However, the North American Menopause Society (NAMS) states that topical estrogen therapy is an effective treatment and safer than oral estrogen.

They write, “low-dose local estrogen is applied directly to the vagina to restore vaginal health and relieve vaginal dryness and discomfort with sexual activity. Improvements usually occur within a few weeks, although complete relief may take several months. This even may be an option for women with a history of breast or uterine cancer but only after careful consideration of risks and benefits with a healthcare provider and oncologist.”

The American College Of Gynecologists (ACOG) published a similar opinion, stating, “Data do not show an increased risk of cancer recurrence among women currently undergoing treatment for breast cancer or those with a personal history of breast cancer who use vaginal estrogen to relieve urogenital symptoms.”

Various forms of vaginal estrogen have been studied, including very low dose vaginal estradiol cream, and have been found effective for the treatment of vaginal dryness and the urinary symptoms that often occur at the same time.

In 2016, the Society of Gynecologic Surgeons (SGS) Systematic Review Group gathered with the goal of comparing the results of safety and effectiveness studies of vaginal estrogens. They analyzed the data from multiple studies comparing how vaginal estrogens compared to each other, placebo, oral estrogen, and non-hormonal treatments to create guidelines providers and patients could follow.

They reported, “Compared with placebo, vaginal estrogens improved dryness, dyspareunia (pain with sex), urinary urgency (sense of a need to urinate), frequency of urination, and stress urinary incontinence (SUI), and urgency urinary incontinence (UUI). Urinary tract infection rates decreased.” They also concluded that patients with more than one symptom benefited most from vaginal estrogen but patients with just one symptom were better candidates to try first a non-hormonal vaginal therapy. Examples of non-hormonal treatments include vaginal lubricants or moisturizers for vaginal symptoms or antibiotics for recurrent urinary tract infections.

They also stated, “The various estrogen preparations had similar efficacy and safety; serum estradiol levels remained within postmenopausal norms.” They also noted, “There were no differences in serum estradiol levels in women taking vaginal estrogen compared with placebo (high-quality evidence).”

The fact that vaginal estrogen (other than the older formulations) do not elevate blood levels of estrogen (estradiol) beyond what is seen in women who are in menopause is a great sign that vaginal estrogen primarily has a local effect. Other studies support that perspective.

Nevertheless, because oral estrogens have been associated with an increased risk of serious conditions like breast cancer, stroke, and abnormal uterine lining (among others), caution has been advised (one year limit, continue seeing a physician, etc.).

Although NAMS has determined that low-dose vaginal estradiol is safer than oral estrogen, there is a small amount of absorption and therefore there still may be some risks. That is why we reference the PDR for estrogen so all the potential risks can be understood.

Your plan includes the use of prescription medication, estrogen vaginal cream, USP 0.01%. It comes in a tube with applicators so the cream can be comfortably inserted at bedtime.

The most common instructions for the use of vaginal estradiol cream are as follows:

1. Use 1-4g measured with the applicator daily for 1-2 weeks, as indicated by your provider

2. Then decrease dosage by 50% for the same period (1–2 weeks)

3. Once the vaginal skin has been restored, use 1g 1–3 times/week

Your provider will personalize your exact dosing. Always follow your provider’s personalized instructions for exact dosing and timing of any step down in or discontinuation of use.

You can see the dosage needed to relieve discomfort varies widely. Your results will determine how much to use—and how often—once you have begun to experience improvement. The amount needed to gain a foothold and stop the problem from progressing (and to heal the vaginal skin) is typically much higher than the amount needed to maintain the improvement.

Getting through that inconvenient first two-week period is key. Apply the medication before bedtime to avoid leakage during the day. One of the reasons women stop using estrogen cream is because it can leak and, if that happens during the day, it can stain clothing. The first two weeks of treatment can be inconvenient due to the potential for leakage after application. In some cases, patients stop using estrogen cream to avoid this problem.

Leakage is less likely to occur when lying flat during sleep. Nevertheless, until the amount used is low and you know how your body handles the cream, it is best to use a small pantyliner even at night—if that is not uncomfortable. Using a light moisturizing lubricant externally is recommended (Rory offers a personal lubricant and daily moisturizer, you can read more here), if the pad causes any discomfort. Knowing and preparing for possible leakage may make sticking with treatment easier.

The practical issues that made estrogen use difficult for some include the application procedures, interference with sexual spontaneity, discharge, administering the proper dose, staining sheets and clothing, uncomfortable sensations, and problems with the medication applicator.

The first two weeks are critical and it is then that many of these annoyances occur. Taking the following steps can help you to avoid most of these concerns:

1. Read about the application of the medication and prepare and practice using the applicator properly. If it is uncomfortable to place it into the vagina, take some time to relax and assume a position that you find most comfortable.

2. If external irritation makes insertion of the applicator painful, use a moisturizer externally a few minutes before.

3. Use a pantyliner at night and in the first few weeks to prevent leakage from staining clothes or bed sheets. It may be unlikely but it is a small precaution to take until you know how your body handles the application of vaginal estrogen.

4. A gentle moisturizer will make using a pad at night more comfortable, as well. Rory offers a vaginal lubricant that can also be used as a daily moisturizer.

5. Sexual spontaneity may be off the table in the first two weeks. It is best to give the medication a chance to work before resuming vaginal intercourse.

6. It bears repeating; use the vaginal estrogen before bedtime. Lying flat through a night will help the medicine reach all the areas it should and it is more likely to remain comfortably in place.

After the initial adjustment period, most women will figure out the dose required to maintain the desired effect.

One important point is that you must review any change in your medical regimen with all your healthcare providers. Changes should never be made without a discussion with your providers. Also, should you develop any new symptoms, let your provider know. They will want to know if you develop infections, vaginal bleeding, breast tenderness, etc. It is unlikely but they will want to hear about any changes.

It is also important for you to continue to see your other providers, including your gynecologist. Entering menopause does not mean that you no longer require ongoing gynecological care. As with all medical conditions, it is important that you keep all of your providers, including your Rory provider, informed. Follow up is necessary to be certain the medications continue to work. Also, if there has been a change in your health status or you begin taking medications that you haven’t informed your provider about, please contact and inform ALL of your healthcare providers, including your Rory provider.

This is a process. Some women respond quickly to treatment. Others require more time and adjustments in their treatment plan. Just remember, success is what happens in the long run. You are not alone on this journey; your provider is here to help.

What can I use in the meantime to help with my dryness?

The vaginal estradiol cream will take several weeks for you to feel a difference in the amount of vaginal lubrication. In the meantime, we recommend vaginal lubricants and moisturizers as an additional treatment to help with dryness.

Vaginal lubricants are an excellent first choice in dealing with mild vaginal dryness during sexual activity. Vaginal moisturizers maintain vaginal moisture. They help prevent itching and general discomfort and can be applied internally a few times/week and can be applied externally daily.

At Rory, we offer a dual vaginal lubricant and moisturizer that is water-based, organic and glycerine-free.

Are there other benefits to vaginal estradiol?

Decreasing levels of estrogen can lead to bladder leakage, fecal incontinence, and increased urinary tract infections. Topical and localized low-dose vaginal estradiol cream can decrease urinary tract infections, improve urinary and fecal incontinence as well help balance the vaginal pH to decrease certain types of vaginal infections.

Additional Information

The educational material that follows will allow you to be a fully informed participant in your healthcare. You will be able to understand your treatment plan thoroughly, as well as other options for treating vaginal dryness. The key is to learn as much as you can and make informed decisions.

Are there any other conditions that can be confused with vaginal dryness due to menopause?

Multiple other conditions can mimic vaginal dryness due to menopause. If vaginal estrogen is ineffective after two months other conditions must be considered.

They include but are not limited to the following:

1. Infections (e.g. Bacterial vaginosis, Candidiasis, Trichomonas)

2. Irritation from personal products that contact the genitals

3. Skin conditions (e.g. lichen sclerosus, lichen simplex chronicus, lichen planus)

4. Vulvar cancer

5. Paget’s disease

Please contact your provider if your symptoms have not improved after two months.

Are there any conditions that could make estradiol vaginal cream an inappropriate treatment for me?

– Undiagnosed abnormal genital bleeding – Known, suspected, or history of cancer of the breast – Known or suspected neoplasia (cancer or abnormal cells) that are affected by estrogen, now or at any time in the past – Any blood clotting problem (e.g. deep vein thrombosis, which is a blood clot in any vein in the body, or pulmonary embolism, which is a blood clot in the lung) now or at any time in the past – Thromboembolic disease (e.g. stroke or heart attack) now or at any time in the past – Known allergy reaction of any severity to estradiol vaginal cream – Known liver disease from any cause or a decrease in liver function – Known protein C, protein S, or antithrombin deficiency or other known disorders that affect blood clotting – Known or suspected pregnancy or breastfeeding

– High blood pressure: Some patients taking oral estrogen have a spike in their blood pressure. It is unusual, but worth noting when you have your annual checkup or if you develop any symptoms. – High triglycerides: Oral estrogen can increase triglycerides in people with high triglycerides. Again, worth checking at your annual exam. – Liver disease: Patients with liver disease may have trouble handling oral estrogen metabolism. Again, it is good to be aware of this information. – Hypothyroidism: Patients on thyroid replacement therapy may require higher doses of medication to treat their hypothyroidism if they take oral estrogen. This can be assessed with the usual tests that monitor thyroid treatment. – Retaining fluid: Estrogen can increase fluid retention and should be used with caution in patients with conditions where this could cause problems, like heart failure and kidney failure. – Worsening of endometriosis: There have been cases of women with endometriosis who have had a hysterectomy but have residual endometrial tissue in their pelvis. Your Gynecologist should be told you are on estrogen vaginal cream. It is a wise precaution. – Oral estrogen therapy has been known to make some of the following conditions worse and should be used with caution in these patients (people with asthma, diabetes, epilepsy, migraines, lupus, porphyria, or abnormal liver blood vessels called hemangiomas).

What are the most common side effects of oral estradiol?

The Prescribers’ Digital Reference (PDR) lists the following common side effects for oral estradiol:

– Headache, back pain – Weight gain – Skin irritation, itching – Diarrhea, nausea, abdominal pain – Period cramps, breakthrough bleeding – Pain in the breasts – Nausea – Abdominal pain

Are there any drugs that interact with estradiol?

The PDR lists the drugs that interact with estrogen. Since low-dose vaginal estrogen has minimal systemic absorption, most of these interactions are not significant. Nevertheless, it is important that all your providers and pharmacists know every medication, supplement, or herb you are taking.

However, there is a much lower risk of side effects with low-dose vaginal estradiol than with oral estrogen aside from local skin reactions. A recent 18-year study that examined “the associations between vaginal estrogen use and multiple health outcomes including cardiovascular disease (total myocardial infarction, stroke, and pulmonary embolism/deep vein thrombosis), cancer (total invasive, breast, endometrial, ovarian, and colorectal cancer), and hip fracture,” concluded the following:

“Vaginal estrogen use was not associated with a higher risk of cardiovascular disease or cancer. Our findings lend support to the safety of vaginal estrogen use, a highly effective treatment for genitourinary syndrome of menopause.”

There are many other less common but potential side effects, including the more serious ones identified in studies of oral estrogen, and which carry significant warnings from the FDA. For a complete list of side effects, see the PDR.

Why does Rory not offer oral hormone replacement therapy (HRT) with estrogen and progesterone for vaginal dryness?

For the majority of women with vaginal dryness, local low-dose (non-systemic) estrogen therapy applied directly to the vagina is an effective treatment for vaginal dryness. Due to the concerns about blood clots, stroke, and breast cancer from the WHI study, many women are not candidates for oral or systemic hormone replacement (estrogen +/- progesterone) therapy. Many others are concerned about the risks associated with systemic hormone replacement therapy. For this reason, we have chosen to offer localized low-dose estrogen treatment directly to the vagina that has been proven effective to treat vaginal dryness.

There are a number of steps women can take to prevent and treat vaginal dryness related to menopause. This includes everything from exercises to topical estrogen therapy, and many treatments can be used in combination. You and your healthcare provider should balance the benefits and the risks in the use of any treatment. If you would like to explore different treatment options, get in touch with your Rory-affiliated provider. Some of the treatments mentioned below may not be offered through Rory, so you may need to seek additional guidance from your primary healthcare provider.

Over-the-counter (OTC) treatments

Non-hormonal Remedies (adapted from NAMS recommendation)

– Vaginal lubricants are an excellent first choice in dealing with mild vaginal dryness during sexual activity. Their regular use may reduce discomfort with sexual activity. The choice of personal lubricant is often quite personal, but it is generally recommended that patients use a water-based lubricant to relieve the symptoms of vaginal dryness. The vaginal lubricant available through Rory is a safe, natural product that is long lasting and precisely mimics natural secretions. Oil-based lubricants may lead to increased infections and discomfort, and alcohol containing lubricants can burn. – Vaginal moisturizers help prevent itching and general discomfort by maintaining vaginal moisture. They are typically applied internally a few times/week at night to avoid leakage. The vaginal lubricant available through Rory can also be used as a daily vaginal moisturizer. – Regular sexual stimulation increases vaginal blood flow and results in increased secretions. The good news is that any sexual stimulation will be beneficial. It does not require a partner. However, as you will read below, combining stimulation with vaginal penetration helps to maintain the width of both the vagina and the introitus (the opening to the vagina). Again, a partner is not an absolute necessity to complete this exercise. – Vaginal dilators are helpful if there have already been some changes in the width, length, or flexibility of the vagina and the opening to the vagina. Used prudently and with guidance from a healthcare professional, dilators can be a safe and effective aid in regaining lost comfort and function. – Pelvic floor exercises (Kegel exercises) may be very helpful, especially if there is a tendency to “tighten up” due to pain when having sex. – Sexual pleasure and intimacy can include many activities other than penetrative vaginal intercourse. Orgasm can be achieved by both partners through genital stimulation by other methods. Occasionally, more explicit directions are required than those implied here, and the help of a sex therapist can be a very helpful step taken by a couple.

Prescription Treatments

Systemic Hormone Replacement Therapy (estrogen with or without progesterone)

Estrogen is the oldest, most effective prescription drug for the treatment of vaginal dryness (and other menopausal symptoms). It comes in oral, transdermal patch, vaginal ring, spray, and gel formulations. These formulations are made from a group of related estrogens including conjugated equine estrogen (CEE), synthetic conjugated estrogens, micronized 17b-estradiol, and ethinyl estradiol.

In women who still have a uterus, these drugs should be used with a progestogen (progesterone) because estrogen alone increases the risk of endometrial hyperplasia and cancer. The exception is a drug called Duavee (conjugated estrogens/bazedoxifene). In this formulation, conjugated estrogen is paired with a selective estrogen receptor modulator (SERM) that protects the uterus. In general, it is recommended the lowest dose of hormones for the shortest duration possible be used.

Oral estrogen is highly effective in treating the local genital and urinary symptoms of menopause, as well. The Women’s Health Initiative (WHI) study scared many women and providers away from the use of estrogen. This study enrolled around 27,000 women and had two treatment arms. In one arm, conjugated equine estrogens (CEE) were used alone and in the other arm, CEE was used together with a synthetic progestin called medroxyprogesterone acetate (MPA). Both of these groups were compared with a placebo group, which took neither drug.

The results of the study showed an increased risk of stroke and deep venous thrombosis (blood clots in the legs) in the CEE group with a decreased risk of hip, vertebral, and wrist fractures. There was no difference in overall mortality. The results also showed that the CEE+MPA group had an increased risk of stroke, pulmonary embolism (blood clots in the lungs), deep venous thrombosis, and invasive breast cancer with a decreased risk of hip, vertebral, and wrist fractures. The CEE+MPA group also showed no difference in overall mortality.

However, the negative effects identified in this study differed based on the woman’s age. In women ages 50–59 who are fewer than 10 years postmenopausal and who don’t have contraindications, the risk of complications was not increased. Moreover, there seemed to be a benefit on total mortality (although it did not reach statistical significance).

Also, the WHI study was done with different chemicals than the ones naturally produced. The form of estrogen found in the body is called 17-beta estradiol and the form of progesterone is progesterone. These molecules are different from CEE and MPA used in the WHI study. Estradiol and micronized progesterone (both now commercially available) are identical to the natural hormones produced by the body. It is possible that the risks found in the WHI study would not be present with these hormones, but at present, this is not known.

Ospemifene

Ospemifene is a daily tablet (taken by mouth) used to treat painful intercourse caused by vaginal atrophy. It is an estrogen agonist/antagonist, which means it works like estrogen (in places where you want more estrogen) and opposes estrogen’s effect (in places where estrogen could cause harm).

Dehydroepiandrosterone (DHEA)

Dehydroepiandrosterone (DHEA) also treats vaginal atrophy but is placed in the vagina. Even though it can be converted into estrogen in the body, blood levels of estrogen do not seem to rise when it is used.

Menopause is defined as a woman not having her period for 12 months. The ovaries stop producing large amounts of estrogen and progesterone and women no longer ovulate. Hormonal changes and symptoms usually begin before this happens, during a time called “perimenopause.” During the perimenopausal period, large fluctuations in hormone levels are thought to cause symptoms including irregular menstrual cycles, headaches, mood changes, insomnia, weight gain, breast pain (mastodynia), and hot flashes/flushes. With the onset of menopause, a dramatic decrease in estradiol (the body’s primary estrogen) and progesterone causes a host of changes in the body, including:

– Hot flashes: This is the most common symptom of menopause affecting over 75% of women during midlife. These symptoms typically last for 5–7 years but can last for up to 10–15 years in some women. If you have any of these symptoms, you may benefit from reading about the options available from your provider. – Absence of menstrual cycles: This is the hallmark of menopause. Once women stop ovulating, their uterine lining no longer grows and sluffs off as it does during a normal cycle. – Loss of bone density: Estrogen blocks the development of cells that cause the breakdown of bone called “osteoclasts.” When these cells are allowed to go unchecked by estrogen, bone density is lost. When bone density drops below a certain point, the result is a disease called osteoporosis. People with osteoporosis have a higher risk of bone fractures, including hip fractures, wrist fractures, and vertebral fractures. – Weight gain and bloating: Estrogen plays an important role in regulation of fat tissue and many women find that maintaining their weight becomes very difficult during this time. – Mood changes: Mood changes, like depression, are common during perimenopause and menopause. – Sleep disturbances: Sleep disturbance may be due to night sweats, but some women also have sleep problems separate from their night sweats. If you have menopause associated sleep disturbances, you may benefit from reading about the options available from your provider. – Increased risk of cardiovascular disease – Vaginal changes: These include vaginal shrinkage, loss of vaginal folds (rugae), loss of vaginal lubrication, vaginal itching and discomfort, and painful sex (dyspareunia). – Urinary symptoms: These can mimic a urinary tract infection (UTI), including urinary frequency, urgency, and painful urination. UTIs are more frequent, as well.

Although perimenopause and menopause are challenging times in a woman’s life, certain conditions that are worsened by higher estrogen levels actually improve after menopause. These include symptoms due to premenstrual syndrome (PMS), endometriosis, uterine fibroids, adenomyosis, and symptoms related to heavy, painful periods.

Are there specific health concerns that I should know that become more important during, and after, the menopausal transition?

Menopause does not mean that your general health will automatically deteriorate. However, preventive healthcare needs do change around this time. This is partly due to menopause itself and partly due to age. Here are some of the most important things to consider as you enter the perimenopausal/menopausal years:

Breast cancer screening: Breast cancer is the second most common cancer in women and the second most common cause of cancer-related deaths. The lifetime risk of breast cancer is about 12% or one in eight women—and most of these cancers occur in women with no specific risk factors. The risk for breast cancer increases with age with most women being diagnosed after the age of 50. Women aged 40–49 have a higher risk than younger women but not as high as after the age of 50.

Cancers diagnosed earlier have a better prognosis with a higher chance of survival. Many medical organizations have made recommendations about breast cancer screening. In general, screening for breast cancer with mammography in average-risk women should begin sometime between the ages of 40 and 50, depending on which recommendations are followed. Screening should be done every one or two years and continue to age 74.

Osteoporosis screening: One of the important functions of estrogen is to maintain bone density by inhibiting the development of cells that break down bone, called osteoclasts. The steep decline in estrogen levels that accompany menopause causes a decrease in bone density.

Osteoporosis is diagnosed when bone density decreases beyond a certain point. Osteopenia is a milder form of loss of bone density. These conditions greatly increase the risk of bone fractures. Fractures cause significant suffering and can even lead to death in the case of hip fractures.

Screening can help diagnose osteoporosis or osteopenia before a fracture, and treatment can be initiated to decrease the risk of fractures. The United States Preventive Services Task Force (USPSTF) recommends screening for osteoporosis in women aged 65 and older without risk factors for osteoporosis and for postmenopausal women younger than 65 who are at increased risk of osteoporosis. Screening is done with a dual-energy x-ray absorptiometry (DEXA) scan. The most commonly used tool to screen for fracture risk is the FRAX calculator. Some risk factors include smoking, caucasian race, rheumatoid arthritis, heavy alcohol use (three or more drinks per day), and people taking glucocorticoids (e.g. prednisone and hydrocortisone) for any condition.

Cervical cancer screening: Cervical cancer screening continues to be important throughout and after the transition to menopause. The USPSTF recommends cervical cancer screening with pap testing every three years or pap testing plus testing for high-risk HPV testing every five years. Women should stop cervical cancer screening if they fulfill one of the following: – Women who have had a hysterectomy (with the removal of the cervix) due to reasons other than cancer should stop screening if they have no history of abnormal pap smears. – Women over 65 should stop cervical cancer screening if they’ve had three negative paps in a row or two negative pap plus HPV tests in a row within the past ten years, with the last test being in the previous five years.

Cardiovascular disease: Male sex is considered a nonmodifiable risk factor for cardiovascular disease. However, after menopause, women have greater increases in cardiovascular risk and end up catching up to their male counterparts. This seems to be at least partially due to the withdrawal of a protective effect of estrogen on different parts of the cardiovascular system.

Hormone therapy after menopause has not been shown to protect against cardiovascular disease, although there is a possibility that it is protective if started in younger women who have gone through menopause more recently.

Cardiovascular risk factors that should be addressed are high cholesterol, high blood pressure, smoking, and diabetes. This is also a great time to pay more attention to a healthy diet and begin an exercise program (with your provider’s approval) if you don’t already have one.

Colorectal cancer screening: Colorectal cancer is the third most common cancer in women and the third most common cause of cancer deaths in women. Early detection through screening can save lives. Most colorectal cancers are diagnosed after age 50, although cases in people under 50 are on the rise.

For people with average risk, the USPSTF recommends screening for colorectal cancer starting at age 50 and continuing to age 74. The American Cancer Society recommends screening for colorectal cancer starting at age 45 in those with average risk and continuing to age 74. People aged 75–84 can discuss continuing screening with their provider. Colon cancer screening should stop once people reach 85. Various screening methods are available, including colonoscopy, fecal immunohistochemistry (FIT) testing, flexible sigmoidoscopy, Cologuard, and CT colonography. Discuss with your provider which method is best for you.

A special note regarding sexual transmitted infections and HIV/AIDS

According to the Centers for Disease Control and Prevention (CDC), of the almost 40,000 new HIV diagnoses in the United States in 2016, 6,812 (17%) were in people aged 50 and older. The American College of Obstetrics and Gynecology (ACOG) reported in 2005 that older women may especially be at risk because of age-related vaginal dryness and thinning that can cause tears in the vaginal lining. These tears, even if they are too small to see, may increase the chances of transmission of HIV and other sexually transmitted infections. It is important to practice safe sex, including condom use, to decrease the risk of sexually transmitted infections even if you are no longer concerned about contraception.

IMPORTANT:

If you experience any unusual side effects, contact your Rory provider or your primary care provider. If you are having a medical emergency, call 9-1-1 or go immediately to your local emergency room. Any new symptom should be discussed with your provider. Any severe symptom should be treated as an emergency. Contact your provider after it is addressed. Again, take the time to read the list of potential side effects.

If you have any questions about this information or any other concerns, we’re here for you. Please contact your provider to discuss any questions or concerns.