FOR WOMEN OF A CERTAIN age, the prospect of approaching menopause can feel like venturing into the great unknown. Besides not having advance notice of when they’re likely to reach this reproductive milestone, there has been a scarcity of safe, effective treatments to relieve the most bothersome symptoms related to the menopausal transition (such as hot flashes and night sweats). Fortunately, new developments offer considerable help on both fronts.
In October, the Food and Drug Administration approved the PicoAMH ELISA diagnostic test as a tool that clinicians can use to help determine a woman’s menopausal status. Marketed under the name MenoCheck, the test measures the amount of anti-Müllerian hormone, or AMH, in a woman’s blood. Considering the test results along with a woman’s age “is highly predictive of ovarian reserve and timing of menopause,” says Dr. JoAnn Pinkerton, executive director of the North American Menopause Society and professor of obstetrics and gynecology at the University of Virginia Health System in Charlottesville. “Using age and AMH together, we should be able to determine whether a woman is likely to go into menopause in the next five or 10 years.”
The test is most commonly used to predict ovarian reserve – how well ovaries are still functioning – in younger women who are either trying to get pregnant or want to delay pregnancy until later in life, Pinkerton says. “Women with abnormal AMH (levels for their age) need to be informed that menopause may occur early,” she explains, which means decreased fertility and the onset of menopausal symptoms and health risks at a younger age.
The simple blood test also may be especially helpful for women who are at risk of early ovarian failure after chemotherapy for cancer or for genetic reasons or who have troublesome perimenopausal symptoms (such as hot flashes, night sweats and sleep disturbances). For example, if a 50-year-old woman who is still menstruating has an undetectable AMH level on the test, there’s a good chance that she will have her last period within the next year or two (the average age of menopause is 51). But if her AMH level turns out to be higher than expected for her age, well, that’s another story.
In particular, “women who have heavy menstrual bleeding and want to avoid having a hysterectomy might benefit from knowing that the bleeding won’t last much longer,” says Dr. Nanette Santoro, E. Stewart Taylor Chair and professor of obstetrics and gynecology at the University of Colorado School of Medicine in Denver. “On the other hand, if they have a high AMH and they know they are looking at five or more years of bothersome symptoms, they may feel more comfortable choosing a more aggressive option.” The test results could help other women decide whether they should invest in another five-year IUD or contraceptive implant if they’re looking for long-acting contraception.
For others, figuring out their menopausal timetable, especially if they have a low AMH level, can better inform preventive health measures they might take. “Early menopause, whether it’s spontaneous or due to surgery or medications such as chemotherapy, is associated with a higher risk of osteoporosis and fracture, heart disease, cognitive changes, vaginal changes, loss of libido and mood changes,” Pinkerton notes. If it’s discovered that a woman is likely to have early menopause, she should be advised to take adequate calcium and vitamin D (1,200 mg and 1,000 to 2,000 IU daily, respectively), keep her weight down with a healthy diet and regular exercise and be evaluated for risk for bone loss, Pinkerton says. When it comes to preventing heart disease, recommendations should include regular cardio exercises and strength-training workouts, eating fiber-rich foods and lots of vegetables and fruits, avoiding fried and sugary foods, reducing calorie intake and managing other cardiovascular risk factors (such as high blood pressure, blood sugar and cholesterol levels).
A Game-Changing Treatment
In another menopausal milestone, in October the FDA approved the first and only form of bioidentical hormone therapy, a combination of bioidentical estradiol and progesterone, for the treatment of moderate to severe vasomotor symptoms (such as hot flashes) in women who have a uterus. (The term bioidentical means the substances have the same chemical and molecular structure as the hormones that are produced in a woman’s body.) Called Bijuva, the oral prescription medication comes in a soft gel capsule to be taken once a day; it’s expected to become available in the U.S. in spring 2019.
While Bijuva is approved for the treatment of hot flashes, it also helps prevent bone loss and improve vaginal dryness associated with menopause, Pinkerton says. “The combination of estrogen and progesterone work in the central thermoregulatory center of the brain to decrease hot flashes, in the bone to prevent bone loss and in the vagina to rebuild missing superficial cells which improve moisture and prevent painful sex.”
Despite all these benefits, this breakthrough therapy isn’t for every woman who is bothered by menopausal hot flashes and night sweats. For one thing, women need to have a uterus to take Bijuva; without a uterus, women don’t need progesterone, only estrogen to relieve menopausal symptoms, Santoro says. Even if they do have a uterus, women who have the usual contraindications for systemic estrogen therapy – a prior history of breast or uterine cancer, liver disease, a high risk of blood clots or previous blood clots, a previous heart attack, unexplained vaginal bleeding or uncontrolled high blood pressure – should not use Bijuva, Pinkerton says.
But for many women who can safely take hormone therapy to relieve maddening menopausal symptoms, this new therapy is likely to be seen as a major blessing. “It does the same thing that other forms of hormone therapy do but it’s got the advantage of using naturally occurring estradiol and progesterone, exactly as the body would produce (before menopause), with both hormones in the same capsule,” Santoro says. “Until now, women who have needed estrogen and progesterone hormone therapy have had to take a combination pill that contained conjugated equine estrogen and medroxyprogesterone acetate – neither of which naturally occur in women – or a combination patch that had naturally occurring estradiol plus a synthetic progesterone, or two pills or a patch plus a pill to get the equivalent hormone therapy.”
What’s more, insurance plans are expected to cover the cost of Bijuva, unlike with compounded bioidentical hormone products that women usually have to pay for out of pocket. And because Bijuva is FDA-approved, it’s considered a significant improvement over custom-compounded bioidentical hormones, which are exempt from the rigorous testing the FDA requires for drugs. “Compounded bioidentical hormones do not have to demonstrate either safety or efficacy,” Santoro explains, because “they are considered dietary supplements.” This means that with Bijuva, women won’t need to be concerned about dosing irregularities, the presence of contaminants or purity or sterility issues the way they are with compounded bioidentical hormone formulations.