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Choosing a hormone therapy that’s right for her

Most women will experience symptoms of estrogen decline as they transition through the menopausal years. These can include vasomotor symptoms (VMS)  and those related to vulvovaginal atrophy, now known as genitourinary syndrome of menopause (GSM). These VMS and GSM symptoms can have an adverse impact on quality of life (QOL). 1.2 Although some women tolerate these symptoms or can improve them with lifestyle changes or non-pharmacologic measures, other women, depending on symptom severity and QOL impact, might benefit from hormone therapy (HT).

Nurse practitioners (NPs) caring for women are familiar with HT options such as the various estrogen and progestogen formulations and the combination estrogen/selective estrogen receptor modulators. Providing patient-specific guidance regarding options is critical in improving satisfaction and compliance. This article provides a short discussion of estrogen products in general, and addresses the attributes of a transdermal gel product that some women find appealing in terms of its ease of use and efficacy in treating both VMS and the symptoms of GSM.

Exogenous estrogen options

Once it is determined that a patient is a candidate for HT and that her VMS, and possibly vaginal dryness as well, are significantly affecting her QOL, patient discussion should be initiated regarding HT options. The objective is to arrive at a mutual decision about the particular type of exogenous estrogen, dosage, and route of delivery that is a best “fit” for the woman. For those women who desire an estrogen product and who have been informed of the risks associated with estrogen use, formulations containing estradiol, conjugated equine estrogens, plant-based estrogens, or esterified estrogens are available. Some women may have a preference regarding an animal-derived estrogen, plant-based estrogen, or synthetic estrogen formulations.

Non-oral estrogen products may have a safety advantage over oral estrogen products.3 Because oral estrogen products, including oral estradiol,  undergo first-pass hepatic metabolism, they may be more likely than non-oral estrogens to lead to adverse metabolic changes such as elevated triglycerides, decreased low-density lipoprotein particle size, and increased production of certain coagulation factors and C-reactive protein. 4 A growing boyd of observational evidence suggests that transdermal estradiol, as compared with oral estrogen, may be associated with lower risks for cardiovascular disease, 7 cerebrovascular disease, 6 and venous thromboembolism. 7,8

Transdermal HT options

There are four transdermal options for VMS relief – patch, emulsion, spray, gel – and one intravaginal option. Other intravaginal estradiol products include creams, a ring, and a tablet. These products are reserved for women whose sole menopause-regulated complaints involve GSM symptoms. 9 Numerous clinical trials conducted over the past two decades have evaluated the efficacy and safety of the transdermal patch, 10-16 emulsion, 17 spray, 18 and gel 1,2,19 in controlling VMS.  One aspect of the non-patch transdermal estradiol products is that they vanish after they are applied and then dry, with no visible signs that HT is being used.

More about one estradiol gel product

Among all of the non-patch transdermal estradiol products, including the gel products, only one, EstroGel 0.06% (estradiol gel), has an FDA-approved dual indication: relief of moderate to severe VMS and relief of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause.20 Clinical research showed that the use of EstroGel at a dosage of 1.25 g (containing 0.75 mg estradiol), as compared with placebo, was associated with significant reductions in the frequency and severity of moderate to severe hot flashes at weeks 4 and 12. 20 In the same study, vaginal wall cytology results demonstrated a significant increase from baseline in the percent of superficial epithelial cells at week 12 for EstroGel versus no significant change from baseline for placebo. The most commonly reported side effects of EstroGel in clinical studies were breast pain, headache, and flatulence. 20

A survey of EstroGel users (N=890) related to product satisfaction showed that 88% were satisfied or extremely satisfied with it and 89% thought it was very easy to use. 21 Among the 620 respondents who had used a previous therapy for their menopausal symptoms, 89% reported that they preferred EstroGel, 7% had no preference, and 4% preferred the previous product.

One pump of the EstroGel metered-dose dispenser supplies one dose of the gel (1.25 g), which contains 0.75 mg of estradiol. The gel is applied to clean, dry, unbroken skin at the same time each day. The patient applies the gel to one arm from wrist to shoulder; she need not massage or rub in the gel. after applying the gel, which dries in 2-5 minutes and leaves no odor or sticky residue, she should wash her hands with soap and water to reduce the chance of medication spread.

All systemic estrogen users with an intact uterus should consider adding a progestogen to their HT regimen in order to reduce the risk of endometrial cancer. 3 Several synthetic progestogens and oral micronized progesterone are FDA approved for this purpose. Oral progestogen may be added as a separate pill or a provided as a combined estrogen-progestogen pill. Combination estrogen-progestogen transdermal patches are also available. Topical cream or gel preparations of progestogen may not exert sufficient activity to protect the endometrium and are not approved for this purpose.

Regardless of which HT is used, the North American Menopause Society recommends prescribing estrogen at the lowest effective dose for the shortest time needed. 9 NPs can assist each woman in navigating through the array of HT options to facilitate selection of the regiment and/or delivery system that is most appropriate for her unique needs.

Anne Moore is the Women’s Health Clinical Trainer at the Tennessee Department of Health, Division of Family Health and Wellness, in Nashville, and a member of the Editorial Advisory Board for Women’s Healthcare: A Clinical Journal for NPs. An honorarium funded by Ascend Therapeutics has been received by Ms. Moore.

Visit https://npwomenshealthcare.com/?p=4166 for a complete list of references.

 

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