Frequently Asked Questions
To find out more about estrogen therapy, please click on a frequently asked question listed below. As always, please talk with your healthcare professional about any questions or concerns you may have about estrogen therapy.
While all estrogen therapies have similarities, there are differences in dosage strength, delivery (patch, pill, topical products, or vaginal ring), indication (used for the treatment of menopause symptoms, such as vaginal dryness or hot flashes), and frequency (every day, twice a week, etc). In addition, some therapies include a combination of hormones, while others are estrogen-only.
Transdermal dosing allows estrogen to be absorbed through your skin and enter into the bloodstream directly, without first circulating through the liver, so it can be administered at lower doses than hormone pills. When taking pills, higher doses are often needed because some of the estrogen is broken down by your liver before it can affect your symptoms.9
Another advantage is that a transdermal therapy provides continuous concentrations of estrogen throughout the day. This avoids the fluctuating estrogen levels that often occur after taking pills.9 Some people may find that it is easier to apply something to the skin than to take a pill.
Although some oral tablet formulations contain bioidentical estradiol, all transdermal preparations contain bioidentical estradiol.1
To make matters a little more confusing, some custom-compounded formulations—made using chemical “recipes” of hormones in differing doses—are often called bioidentical.
Custom-compounded hormones can be appropriate for some women. This formulation of estrogen can be used by those women who cannot tolerate commercially
manufactured forms.1
Custom-compounded products have not been tested for purity, potency, efficacy, or safety, so there is no scientific evidence about them one way or the other. It is possible that these untested mixtures may even contain unknown contaminants.1
Every woman is unique, so there is no one answer for which kind of treatment is right for you. The bottom line is, before seeking custom-compounded hormones, talk with your healthcare professional about your treatment goals, your personal and family medical history, and the potential risks of any and all medications you are currently taking or thinking about taking.
- The Women’s Health Initiative (WHI) was a landmark research initiative that started in 1991. Over 27,000 women participated in the hormone therapy (HT) trial22
- The participants of this study were generally healthy postmenopausal women aged 50 to 79, with an average age being about 64. In 2 separate arms, these women were given either placebo (sugar pill), estrogen plus progestin, or estrogen alone once daily for up to 7 years22
- The goal of the study was to evaluate what effect hormone therapy had on heart disease prevention, breast and colorectal (colon and rectum) cancer, bone loss, and other outcomes. In addition, the investigators wanted to gain a better understanding of the good—and bad—effects of using menopausal hormone therapy22
- The goal was not to evaluate whether or not hormone therapy was an effective therapy for menopausal symptoms
- Only one brand of oral estrogen therapy and only one brand of oral estrogen-plus-progestin therapy were studied22
- The WHI study was halted prematurely due to concerns about certain risks observed in some participants22
The WHI involved 2 separate studies, 1 on women without a uterus taking an estrogen-alone pill and the other on women with intact uteruses who were taking an estrogen-plus-progestin pill.22
Women receiving estrogen alone were found to be at an increased risk for stroke and blood clots, compared to women taking placebo.22
Women receiving estrogen-plus-progestin hormone therapy were found to be at an increased risk for breast cancer, heart attack, stroke, and blood clots, compared to placebo.22
A substudy of the WHI also reported an increased risk in dementia in women on hormone therapy who were 65 years of age or older compared to placebo. It is not known if this applies to younger postmenopausal women.22
While hormone therapy continues to be the proven and FDA-approved therapy for relief of menopausal symptoms, it should be used at the lowest effective dose for the shortest time possible.22
More research is needed, but the WHI has caused the healthcare community to take a fresh look at menopausal treatments. As a result, there are many new low-dose treatment options and best practices.
All estrogen hormone therapies, regardless of form, administration type, and dosage, carry FDA warnings about potential but serious risks for some women:
- Increased risk of cancer of the uterus
- Increased risk of heart attacks, strokes, breast cancer, and blood clots
- Increased risk of dementia
In addition, women who may be pregnant or who have unusual vaginal or uterine bleeding (that is, abnormal or cannot be explained), who have or have had certain cancers (including cancer of the breast or the uterus), who have had a stroke or heart attack within the last year, who have had blood clots, or who have had liver problems should not take estrogens.
To learn more about the potential risks of estrogen therapy, please read the full Prescribing Information for Divigel®.
If you are experiencing disruptive hot flashes, including night sweats, ask your healthcare professional if one of these newer options, including Divigel®, is right for you.
Please remember, Divigel® has not been studied as a drug to prevent osteoporosis and is not intended for or approved by the FDA for the prevention of osteoporosis or for protection against bone loss.2
There are a number of FDA-approved options available for the prevention for bone loss, so talk to your healthcare professional about which one is best for your individual needs.
It’s important to recognize that in the United States, supplements are not held to the same FDA regulations and standards that are applied to prescription medications. As a result, not all scientific evidence to support many of the claims made by these natural, herbal supplements is reviewed by the FDA.1
You need to be aware that these supplements may cause side effects, and that they may also negatively interact with other medications you may be taking. Unlike prescription medications that carry an FDA-mandated prescribing information detailing this safety information, herbal supplements do not. Before you do decide to use herbal supplements, please speak with your healthcare professional.1
Important Safety Information for Patients
The following are not all the possible risks for Divigel®. Please read the full Patient Information leaflet and talk to your healthcare provider.
Estrogens increase the chance of getting cancer of the uterus. Report any unusual vaginal bleeding right away while you are taking estrogens. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause. In general, the addition of a progestin is recommended for women with a uterus to reduce the chance of getting cancer of the uterus.
Do not use estrogens, with or without progestins, to prevent heart disease, heart attacks, or strokes. Using estrogens, with or without progestins, may increase your chance of getting heart attacks, strokes, breast cancer, and blood clots.
Do not use estrogens, with or without progestins, to prevent dementia. Using estrogens, with or without progestins, may increase your risk of dementia.
Do not use estrogen products, including Divigel®, if you have unusual vaginal bleeding, currently have or have had certain cancers, had a stroke or heart attack in the past year, currently have or have had blood clots, currently have or have had liver problems, are allergic to any Divigel® ingredients, or think you may be pregnant.
The most common side effects for all estrogen products are headache, breast pain, irregular vaginal bleeding or spotting, stomach/abdominal cramps and bloating, nausea and vomiting, and hair loss. The less common but serious side effects include breast cancer, cancer of the uterus, stroke, heart attack, blood clots, dementia, gallbladder disease, and ovarian cancer.
In Divigel® clinical trials, the most common side effects were inflammation of the nasal passages and pharynx, upper respiratory tract infection, vaginal yeast infection, breast tenderness and vaginal bleeding. Call your healthcare provider right away if you have any symptoms that concern you.
Estrogen products should be used at the lowest dose possible for your treatment and only as long as needed. You and your healthcare provider should talk regularly about whether you still need treatment with Divigel®.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
For more information, call 1-800-654-2299.
©2012 Upsher-Smith Laboratories, Inc., Maple Grove, MN 55369
