CLINICAL ACTIONS:

If a patient complains of dyspareunia, and clinical examination is consistent with postmenopausal vaginal atrophy / atrophic vaginitis, local estrogen is the first line of treatment, but there are alternatives that can be considered if the following two criteria are met:

• Ascertain if the patient can, indeed, use estrogen and ensure that option was offered and an informed decision to decline was met
• Screen for a history of breast or uterine cancer, history of blood clots or liver conditions

SYNOPSIS:

Some postmenopausal patients will not or cannot use local estrogen replacement therapy to treat vaginal atrophy/atrophic vaginitis. Common situations in which this is the case may include personal history of estrogen-sensitive breast cancer or endometrial cancer, although NAMS guidelines do recommend that low-dose local HT may be an option, in consultation with a patient’s oncologist in certain situations. Fortunately, a number of effective options are available for these women.

When a clinician cannot prescribe local estrogen, alternatives for postmenopausal vaginal atrophy include

•  Ospemifene – 60 mg daily
  • Should not be used concomitantly with estrogens
  • Should be used for 12 continuous weeks in order to gauge effectiveness
  • Ospemifene is a SERM
    • According to the FDA, there is insufficient data to use ospemifene in women with breast cancer
    • While there do not appear to be any cases of ospemifene causing endometrial cancer, a potential risk for this particular malignancy is mentioned in a boxed warning
• Prasterone – One vaginal insert (6.5 mg) each evening at bedtime
  • FDA approved, steroid-based treatment for postmenopausal vaginal atrophy
  • Use is appropriate for women who complain of dyspareunia due to dryness and thinning of the vaginal mucosa
  • Based on the fact that there is minimal data on safety in the setting of hormonally sensitive malignancy, the FDA warns against using prasterone if there is a history of or known or suspected breast cancer
• Lubricants
  • Have been found to be efficacious and may help alleviate symptoms

Laser Treatment – FDA Statement

• The FDA has released a statement (August 2018) warning that “…safety and effectiveness of these devices hasn’t been evaluated or confirmed by the FDA for “vaginal rejuvenation.” In addition to the deceptive health claims being made with respect to these uses, the “vaginal rejuvenation” procedures have serious risks.”

• ACOG supports the FDA statement and has a position statement advising that while there is there is FDA clearance of fractional C02 laser, indications do not specify treatment of vulvovaginal atrophy, but do include

incision, excision, ablation, vaporization, and coagulation of body soft tissues in medical specialties, including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynaecology, neurosurgery, orthopaedics, general and thorasic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery

• NAMS has also responded and while welcoming the FDA’s mandate requiring companies to provide adequate data, the NAMS statement includes the following to assist with counseling

NAMS recommends that healthcare providers discuss the benefits and risks of all available treatment options for vaginal symptoms, including over-the-counter lubricants, vaginal moisturizers, and FDA-approved vaginal therapies such as vaginal estrogen and
intravaginal dehydroepiandrosterone and oral therapies such as hormone therapy and ospemifene to determine the best treatment for women with GSM. When discussing vaginal energy-based therapies, informed discussion should include that these are FDA-approved devices for gynecology but have not received FDA approval for vaginal rejuvenation or procedures for GSM, sexual function, incontinence, or pelvic laxity and that even though short-term data are promising, more robust, sham-controlled, and longer-term data are needed.

KEY POINTS:

• While alternative treatments will address vaginal dryness and atrophy, patients should be informed of the limitations of these treatments
• Treatments that are effective for managing vaginal atrophy, may not help with other menopausal symptoms such as hot flashes, night sweats or mood

Learn More – Primary Sources:

Effect of Ospemifene on Moderate or Severe Symptoms of Vulvar and Vaginal Atrophy

Genitourinary syndrome of menopause: an overview of clinical manifestations, pathophysiology, etiology, evaluation, and management

ACOG Position Statement: Fractional Laser Treatment of Vulvovaginal Atrophy and U.S. Food and Drug Administration Clearance

FDA Statement: Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to safeguard women’s health from deceptive health claims and significant risks related to devices marketed for use in medical procedures for “vaginal rejuvenation”

NAMS Response: FDA Mandating Vaginal Laser Manufacturers Present Valid Data Before Marketing 

Related ObG Topics:

Does Estrogen Therapy Have Cardiovascular Benefit in Early Postmenopause?

North American Menopause Society: Hormone Therapy Statement

Prescribing Ospemifene for Postmenopausal Vaginal Atrophy

Prasterone for Vulvovaginal Atrophy – What is it and How to Prescribe

Genitourinary Syndrome of Menopause: New Name, Old Problem