Highlights of a new position statement on local estrogen to relieve vaginal atrophy

September 1, 2007

To guide health-care providers about the efficacy, safety, and role of local vaginal ET to treat vaginal atrophy in postmenopausal women, The North American Menopause Society has developed an evidence-based position statement.

Key Points

An estimated 10% to 40% of postmenopausal women have symptomatic vaginal atrophy resulting from cessation of ovarian estrogen production. Symptoms include vaginal dryness, vulvovaginal irritation and itching, and dyspareunia. Unlike vasomotor effects of menopause, the symptoms are usually progressive and do not resolve spontaneously. Even though discomfort from vaginal atrophy can significantly affect quality of life and most often requires treatment, only about one out of every four symptomatic women seek medical help.

The standard treatment for moderate-to-severe vaginal atrophy is low-dose estrogen therapy (ET), given locally or systemically. Vaginal estrogen, delivered by cream, tablet, or ring, has less potential for adverse effects than systemic ET.

To guide health-care providers about the efficacy, safety, and role of local vaginal ET to treat vaginal atrophy in postmenopausal women, The North American Menopause Society has developed an evidence-based position statement. The full text of the document can be viewed on the NAMS Web site at http://www.menopause.org/PSvagestrogen07.pdf. It offers 2 CME hours until 3/15/08.

The primary objectives in managing vaginal atrophy are to relieve symptoms and reverse atrophic anatomic changes. First-line therapies include nonhormonal lubricants and moisturizers. If symptoms do not respond to these treatments, exogenous estrogen may be prescribed to supplement diminished ovarian estrogen production. Unlike age-related changes in the urogenital tissues, most vaginal changes caused by lowered estrogen levels can be reversed.

Both local and systemic (oral, transdermal) ET treat vaginal atrophy effectively, but systemic therapy may be contraindicated or unacceptable because it can cause systemic adverse effects, especially with long-term use. Randomized controlled trials in postmenopausal women, although limited, have shown that low-dose, local vaginal ET is well-tolerated and effectively reverses atrophic changes in vaginal tissues, relieving symptoms while limiting systemic absorption. Its impact on more complex, multifactorial effects of urogenital aging (urinary frequency and urgency, incontinence, and urinary tract infection) are less clear. Local ET does not reduce vasomotor symptoms or the risk of osteoporotic fracture.

Types of vaginal estrogen

Products approved by the FDA for delivering a local dose of estrogen to the vagina to treat atrophy are:

Optimal treatment regimens and minimum effective doses for these products have not been established; clinical regimens are based on protocols used in studies, products available commercially, and government-approved labeling.

Randomized controlled trials have shown the CE vaginal cream, the estradiol hemihydrate vaginal tablet, and the estradiol vaginal ring to be equally effective for treating symptoms such as vaginal dryness, irritation, and dyspareunia. No randomized controlled trials have been done using the estradiol cream. Although the evidence base for vaginal ET is limited, governmental regulatory bodies generally agree that the data show vaginal ET to be effective for vaginal atrophy, especially atrophy caused by estrogen deficiency.

VAGINAL CREAM is the longest-used form of local vaginal ET. The CE cream contains 0.625 mg CE per gram. Data from randomized, controlled trials indicate that the cream is effective at doses from 0.5 to 2.0 g (0.3–1.25 mg CE) administered from once a day to two or three times a week.

A loading dose of 2 to 4 g/d is usually given for 2 weeks, then less often after the initial therapeutic response. The maintenance schedule should be titrated to the lowest effective dose and frequency; one to three doses per week (at least 12 hours before coitus) are usually adequate.