By Rebecca Bowers

By 2020, it is estimated that more than 50 million women in the United States will be older than 51 years of age.1 Since menopause occurs at an average age of 52, clinicians will have to consider how to approach updating their practice to treat this growing patient population.2

The Food and Drug Administration (FDA) recently approved two new modalities to aid in menopause management: MenoCheck, a diagnostic tool to determine a woman’s menopausal status, and Bijuva, a medication to help with hot flashes.

The MenoCheck diagnostic tool is an assay kit used to determine menopausal status in women 42-62 years of age. The assay offers adequate sensitivity to measure declining concentrations of antimullerian hormone (AMH) in women who are beginning the menopausal transition.

Diagnostic results regarding women’s menopausal status may prompt discussions about preventative care for patients who are experiencing the symptoms of menopause, notes Courtney Lias, PhD, director of the FDA’s chemistry and toxicology devices division.

“This test, when used in conjunction with other clinical assessments and laboratory findings, can help inform discussions about preventative care, such as ways to help prevent loss in bone mineral density or to address cardiovascular disease, both of which are known to increase after menopause,” said Lias in a press statement.

How can the tool help inform discussions about preventive care? JoAnn Pinkerton, MD, NCMP, executive director of the North American Menopause Society, advises that if the test results are considered along with a woman’s age, they can be highly predictive of ovarian reserve and timing of menopause. If age and AMH level are used together, they can help determine whether a woman is likely to experience menopause in the next five or 10 years, she explains.

Women who have very low (abnormal) AMH levels for their age may go through menopause early, which can mean decreased fertility or the onset of menopausal symptoms and health risks such as osteoporosis or heart disease at a younger age, states Pinkerton. For women with bleeding problems, knowing whether menopause is likely to come sooner rather than later may affect decisions to treat bleeding, including whether to have a hysterectomy, she notes.

Early menopause, whether it is spontaneous or due to surgical removal of the ovaries or medications such as chemotherapy, has been associated with a higher risk of health problems, says Pinkerton. These include osteoporosis and fracture, heart disease, cognitive changes such as dementia, vaginal changes, loss of libido, and mood changes such as depression.

How can women counter these conditions? Women likely to have an earlier menopause can make lifestyle choices to decrease risk even before becoming menopausal, says Pinkerton. Counsel women about the importance of adequate calcium and vitamin D intake (1,200 mg and 1,000 to 2,000 IU daily, respectively), weight gain avoidance, healthy diet, and regular cardiovascular exercise.

To prevent heart disease, advise patients to include 30 minutes of cardiovascular exercise five days per week, add strength-training, and eat fiber-rich foods, such as vegetables and fruits, while avoiding unhealthy amounts of fats, fried foods, or sugary foods. Having regular check-ups will alert a woman to the risk of high blood pressure, prediabetes, or elevated cholesterol levels, says Pinkerton.

What Defines Menopause?

During the menopause transition, women experience a natural decline of ovarian follicular estrogen production. This transition is characterized by many menstrual cycle changes, including increasing episodes of amenorrhea. With the diminishment of ovarian production of estradiol, women will experience complete absence of menstrual bleeding. Menopause traditionally has been defined as the final menstrual period, diagnosed after 12 consecutive months of amenorrhea.2

It is clinically important to determine where a woman is in the menopause process. The MenoCheck assay was developed to help clinicians understand the symptoms women are experiencing and aid in selecting an appropriate treatment to relieve those symptoms.

Alternative to Compounded Therapy

Bijuva is formulated in 1 mg/100 mg estradiol and progesterone capsules. It is approved for use in the treatment of moderate to severe vasomotor symptoms due to menopause in women with a uterus. In advanced clinical trials, the single-capsule estradiol-progesterone therapy provided effective treatment of moderate-to-severe vasomotor symptoms.3

“This new therapy provides an effective, safe, FDA-approved and monitored therapy for women with a uterus who desire a combined estrogen/progesterone bioidentical product to relieve menopausal hot flashes and night sweats,” says Pinkerton. “It is a novel, effective, and often requested type of therapy for symptomatic menopausal women and their healthcare providers.”

Since the 2002 publication of initial findings from the Women’s Health Initiative (WHI), the largest randomized controlled trial on the effects of menopausal hormone therapy conducted to date, use of menopausal hormone therapy has declined steeply in U.S. women. Use of custom-compounded hormone therapy, whereby hormones are customized by prescription for individual women, has increased since the initial publication of the WHI, as women have sought alternative therapies. In the United States, one-third of women who take hormones at menopause use compounded hormones, according to a national survey.4 However, custom-compounded hormone therapy is not FDA-approved. The amounts of active drug can vary substantially from one prescription to another, and insurance often does not provide coverage of such therapy.

In the past, many women who wanted to use bioidentical hormone therapy have used compounded therapies not approved by the FDA and which are not monitored or regulated by the FDA, says Pinkerton. This has led to safety concerns due to the possibility of over- or under-dosing, the presence of contaminants, the lack of adequate sterility, and the lack of testing for safety and efficacy.

“This new combined estradiol/progesterone one pill therapy gives women with a uterus seeking bioidentical hormone therapy (hormone therapy similar to what the body used to make before menopause) a tested, effective, and safe therapy, which is FDA-approved and FDA-monitored,” states Pinkerton.

REFERENCES

  1. Manson JE, Kaunitz AM. Menopause management — getting clinical care back on track. N Engl J Med 2016;374:803-806.
  2. Shifren JL, Gass ML; NAMS Recommendations for Clinical Care of Midlife Women Working Group. The North American Menopause Society recommendations for clinical care of midlife women. Menopause 2014;21:1038-1062.
  3. Lobo RA, Archer DF, Kagan R, et al. A 17β-estradiol-progesterone oral capsule for vasomotor symptoms in postmenopausal women: A randomized controlled trial. Obstet Gynecol 2018;132:161-170.
  4. Gass ML, Stuenkel CA, Utian WH, et al. Use of compounded hormone therapy in the United States: Report of The North American Menopause Society Survey. Menopause 2015;22:1276-1284.