Mimvey is a medication containing estradiol and norethindrone acetate, prescribed to manage symptoms associated with menopause, such as vasomotor symptoms (VMS). While weight gain is a common concern during menopause and with hormone replacement therapy (HRT), the relationship between Mimvey and weight loss is complex and not definitively established. This article examines the available evidence and considerations related to Mimvey, menopause, and weight management.
Understanding Mimvey
Mimvey is available as an oral tablet in two dosage strengths: 1 mg of estradiol with 0.5 mg of norethindrone acetate, and 0.5 mg of estradiol with 0.1 mg of norethindrone acetate. Estradiol is a form of estrogen, and norethindrone acetate is a progestin. These hormones work to supplement the declining levels of estrogen that occur during menopause, alleviating symptoms like hot flashes, vaginal dryness, and osteoporosis.
Menopause, Hormones, and Weight
The menopausal transition, typically occurring between ages 45 and 55, is marked by a decline in estrogen production by the ovaries, leading to the end of menstrual periods. This hormonal shift can trigger various symptoms, with vasomotor symptoms affecting as many as 80% of midlife women.
The menopause is associated with a decrease in the resting metabolic rate that reduces the utilisation of calories and hence increases body weight. A number of studies have shown that weight gain is greatest in the peri-menopausal years. There also appears to be a redistribution of fat mass at the time of the menopause, with an increase in the waist-to-hip ratio.
Fear of weight gain is one of the main factors contributing to the poor compliance seen with hormone replacement therapy (HRT). Although an increase in weight can be a result of rehydration, (which in turn may alleviate some of the effects of skin ageing), many women consider weight gain to be cosmetically unacceptable. Moreover, excess body weight or certain patterns of body fat distribution can lead to health problems such as cardiovascular disease and breast cancer.
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Hormone Therapy and Weight: What the Research Says
Although it is a common belief that HRT inevitably causes weight gain, available evidence suggests that this is not true. Indeed, some HRT regimens, such as continuous 17beta-oestradiol 2 mg/day combined with sequential dydrogesterone 10 mg/day for 14 days/cycle (Femoston), may actually help to prevent an increase in body fat mass and fat redistribution.
Important Considerations When Using Mimvey
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and does not cause unwanted effects. These visits may be every 3 to 6 months. Blood or urine tests, pelvic exam, breast exam, and mammogram (breast x-ray) may be needed to check for unwanted effects, unless your doctor tells you otherwise. Be sure to keep all appointments. It is unlikely that a postmenopausal woman may become pregnant. But, you should know that using this medicine while you are pregnant could harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.
Using this medicine may increase your risk for having blood clots, strokes, or heart attacks. This risk may continue even after you stop using the medicine. Your risk for these serious problems is even greater if you have high blood pressure, high cholesterol in your blood, diabetes, or if you are overweight or smoke cigarettes. Contact your doctor immediately if you experience chest pain, confusion, difficulty speaking, double vision, headaches, an inability to move arms, legs or facial muscle, or an inability to speak. Using this medicine for a long period of time may increase your risk of endometrial cancer, breast cancer, or uterine cancer. Talk with your doctor about this risk. Do not use this medicine if you have had your uterus (womb) removed (hysterectomy). Check with your doctor immediately if your experience abnormal vaginal bleeding. Using this medicine may increase your risk of dementia, especially in women 65 years of age and older. This medicine may increase your risk of having gallbladder disease. Check with your doctor if you start to have stomach pains, nausea, and vomiting. Check with your doctor immediately if severe headache or sudden loss of vision or any other change in vision occurs while you are using this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor). Tell your doctor or dentist who treats you knows that you are using this medicine before any kind of surgery (eg, surgery that will require inactivity for a long time) or emergency treatment. Your doctor will decide whether you should continue using this medicine. This medicine may also affect the results of certain medical tests. Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.
Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia. The estrogen plus progestin sub-study of the Women's Health Initiative (WHI) reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) per day, relative to placebo. The estrogen-alone sub-study of the WHI reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 6.8 years and 7.1 years, respectively, of treatment with oral conjugated estrogens (CE 0.625 mg) per day, relative to placebo. The Women's Health Initiative Memory Study (WHIMS), a sub-study of the WHI study, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with CE 0.625 mg combined with MPA 2.5 mg and during 5.2 years of treatment with CE 0.625 mg alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. Other doses of oral conjugated estrogens with medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar.
Potential Side Effects of Mimvey
Along with its needed effects, estradiol / norethindrone may cause some unwanted effects. Some side effects of estradiol / norethindrone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine.
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Side effects that you should report to your care team as soon as possible:
- Allergic reactions or angioedema-skin rash, itching or hives, swelling of the face, eyes, lips, tongue, arms, or legs, trouble swallowing or breathing
- Blood clot-pain, swelling, or warmth in the leg, shortness of breath, chest pain
- Breast tissue changes, new lumps, redness, pain, or discharge from the nipple
- Gallbladder problems-severe stomach pain, nausea, vomiting, fever
- Heart attack-pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
- Increase in blood pressure
- Liver injury-right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
- Stroke-sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
- Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss
- Unusual vaginal discharge, itching, or odor
- Vaginal bleeding after menopause, pelvic pain
Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):
- Bloating
- Breast pain or tenderness
- Dark patches of skin on the face or other sun-exposed areas
- Hair loss
- Irregular menstrual cycles or spotting
- Nausea
- Stomach pain
- Swelling of the ankles, hands, or feet
Lifestyle Modifications for Weight Management
Regardless of whether a woman is taking Mimvey or not, adopting healthy lifestyle habits is crucial for managing weight during and after menopause:
- Balanced Diet: Focus on a diet rich in fruits, vegetables, lean protein, and whole grains. Limit processed foods, sugary drinks, and excessive amounts of unhealthy fats. Women with suboptimal dietary intake should carefully consider medications.
- Regular Exercise: Engage in both cardiovascular exercise (like walking, swimming, or cycling) and strength training. Exercise helps burn calories, build muscle mass (which boosts metabolism), and improve overall health. Exercise, weight loss, and cooling techniques may be associated with improvement in VMS, although there are less conclusive data compared to other treatment modalities.
- Adequate Sleep: Aim for 7-8 hours of quality sleep per night. Sleep deprivation can disrupt hormones that regulate appetite, potentially leading to weight gain.
- Stress Management: Practice stress-reducing techniques such as yoga, meditation, or deep breathing exercises. Chronic stress can contribute to weight gain, especially around the abdomen. CBT has been shown to be effective in reducing the severity but not the frequency of VMS in 2 randomized, double-blind, controlled trials: MENOS 1 and MENOS 2.97,98 In clinical practice, limited access and the cost of CBT may be prohibitive factors in its use.
Non-Hormonal Options for Managing Menopause Symptoms
For women who cannot use or choose not to use menopausal hormone therapy, there are many evidence-based non-hormonal options available including pharmacologic therapies. Lasting upwards of a decade for some women, VMS can have a significantly negative impact on overall health and wellbeing.
Multiple clinical trials have identified therapeutic effects of SSRIs and SNRIs in treating VMS. Oxybutynin is an anticholinergic, antimuscarinic medication that the US FDA approved for the treatment of urge incontinence overactive bladder.116 A 12-week, multicenter, double-blind, placebo-controlled Phase II clinical trial comparing 15 mg extended-release oxybutynin to placebo showed significant reductions in frequency and severity of moderate-to-severe VMS through week 12 in the oxybutynin users.116 Women receiving oxybutynin reported improvement in VMS, sleep, and quality of life at 4 weeks, with persistent efficacy at 12 weeks.116 At a dose of 15 mg, oxybutynin was associated with side effects including dry mouth and urinary difficulties. Stellate ganglion block (SGB) is a nonhormone treatment option for VMS. The stellate ganglion is a cluster of sympathetic nerves in the lower-cervical and upper-thoracic area, encompassing the C6 region of the anterior cervical spine.123 By administering a local anesthetic such as lidocaine under fluoroscopic and ultrasonographic guidance, SGB has been used for the past 50 years as a targeted treatment for pain syndromes such as migraine, upper extremity and upper body pain, as well as complex regional pain syndromes.124 While data show that SGB may improve VMS, the mechanism is unclear. Several small studies have shown that, whether approached unilaterally or bilaterally, SGB reduces hot flash severity by 45% to 90% in about 4-24 weeks.123,125 In an RCT of bupivacaine SGB compared to sham-control, only those who suffered moderate-to-severe VMS had significant reduction in symptom frequency.123 Most studies reported no significant adverse events, although there are rare risks associated with the injection itself.124 These complications can include damage to the surrounding areas, such as the vasculature, neural tissue, esophagus, or trachea.124 Risk of complications can be mitigated with imaging guidance. Acupuncture is a potential non-medication alternative for the treatment of VMS. Another novel selective antagonist of the neurokinin pathway focusing on NK1 and NK3 receptors is NT-814.134 In RELENT-1, a 14-day, Phase II, RCT of the safety and efficacy of 50, 100, 150, and 300 mg daily of NT-814, women who received the 150 mg dose had an 84% reduction in hot flashes compared to 37% in the placebo group.
How to Use Mimvey
Take this medication by mouth with a drink of water. You may take this medication with food. Follow the directions on the prescription label. You will take one tablet daily at roughly the same time each day. Do not take your medication more often than directed.
A patient package insert for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently. Talk to your care team about the use of this medication in children. Special care may be needed.
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Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
Where should I keep my medication?
Keep out of the reach of children and pets. Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medication after the expiration date.
NOTE: This sheet is a summary. It may not cover all possible information.
Stopping MHT
If people decide to stop taking hormone therapy, they should reduce the dosage gradually. Stopping abruptly may cause a return of menopause symptoms, such as hot flashes and disrupted sleep.People may wish to stop taking menopausal hormone therapy (MHT) if they have been taking it for a long time, if their menopause symptoms are reducing as they get older, or for other health reasons.
According to the United Kingdom’s National Health Service (NHS), there is no set time for how long people can take hormone therapy. People may take it for 2 to 5 years to treat menopausal symptoms, such as hot flashes, or sometimes longer.People may stop taking MHT because they experience a decrease in their menopausal symptoms, which happens as people get older. They may also decide that the risks of MHT begin to outweigh the benefits. The NHS suggests the risks of hormone therapy may increase as people get older, particularly for people over the age of 60.
According to a 2023 review, people may experience a recurrence in vasomotor symptoms whether they stop hormone therapy gradually or suddenly. This may occur in around 50% of people who discontinue hormone therapy. There is currently no consensus about the best method to discontinue MHT. Therefore, people can work with their healthcare team to ensure they are doing so safely and to monitor any symptoms that may recur. The NHS suggests that healthcare professionals typically recommend gradually reducing their hormone therapy dose over three to six months. People can work with their doctor to reduce their dosage safely. Some healthcare professionals may recommend stopping hormone therapy without tapering the dose. There is currently no clinical consensus about the best method to discontinue this treatment. People may experience a temporary return of some menopausal symptoms when they stop taking MHT. The risk of this may be similar whether someone stops the treatment suddenly or tapers their dose over several months. If symptoms return and persist for more than 3 months, people can speak with a doctor. A doctor may recommend going back on a low dose of MHT to manage symptoms, or they may recommend other treatments.
The length of time someone can take MHT may depend on the individual. Although more research is necessary to understand the long-term risks of ongoing hormone therapy in people ages 60 and older, the NAMS states that healthcare professionals do not need to routinely discontinue MHT in this population. Instead, they encourage healthcare professionals to involve individuals in the decision making process and routinely reevaluate a person’s risk-benefit profile during hormone therapy treatment. The amount of time it takes for hormones to leave the body may depend on the type of hormone therapy people take and the method they use. However, there is a lack of research into how long MHT stays in the system once someone stops using it.