What is the recommended treatment for atrophic vaginitis in postmenopausal women?

From the Guidelines

The recommended treatment for atrophic vaginitis in postmenopausal women is low-dose vaginal estrogen therapy, as it has been shown to be effective in alleviating symptoms such as dryness, burning, itching, and painful intercourse, with minimal risk of adverse effects, as supported by the most recent guidelines 1.

Treatment Options

• First-line options include estradiol vaginal tablets (10 mcg inserted vaginally daily for 2 weeks, then twice weekly), estradiol vaginal rings (released over 3 months before replacement), or conjugated estrogen cream (0.5-1 g applied vaginally daily for 2 weeks, then 2-3 times weekly) 1.
• Non-hormonal options include regular use of vaginal moisturizers (applied every 2-3 days) and lubricants during intercourse.
• For women with contraindications to estrogen therapy, such as history of breast cancer or thromboembolic disorders, ospemifene (60 mg oral daily) or prasterone (6.5 mg vaginal insert daily) may be considered, although the safety of these options is not as well established 1.

Mechanism of Action

• Vaginal estrogen therapy works by restoring vaginal epithelial thickness, improving blood flow, normalizing vaginal pH, and increasing vaginal secretions, which alleviates symptoms like dryness, burning, itching, and painful intercourse.

Efficacy and Safety

• Most women experience significant improvement within 4-6 weeks of starting treatment, though therapy typically continues indefinitely as symptoms often recur when treatment is discontinued 1.
• The safety of vaginal estrogen therapy has been established in several studies, including a large cohort study of almost 50,000 patients with breast cancer, which showed no evidence of increased risk of breast cancer-specific mortality in those using vaginal estrogen 1.

Alternative Options

• Vaginal androgens, such as DHEA, may also be considered for vaginal dryness or pain with sexual activity, although the evidence for their effectiveness is limited and their safety in survivors of hormonally mediated cancers is not well established 1.
• Ospemifene, a selective estrogen receptor modulator, has been shown to be effective in treating vaginal dryness and dyspareunia in postmenopausal women without a history of estrogen-dependent cancers, although its safety in survivors of estrogen-dependent cancers is not well established 1.

From the FDA Drug Label

The effectiveness and safety of OSPHENA on moderate to severe symptoms of vulvar and vaginal atrophy in postmenopausal women were examined in four placebo-controlled clinical trials (three 12-week efficacy trials and one 52-week long-term safety trial). In the four placebo-controlled trials, a total of 1100 women received placebo and 1416 women received 60 mg OSPHENA Effects on Dyspareunia In Trials 1 and 2, the modified intent-to-treat population of women treated with ospemifene when compared to placebo demonstrated a statistically significant improvement (least square mean change from baseline to Week 12) in the moderate to severe most bothersome symptom of dyspareunia (Trial 1, p=0.0012 and Trial 2, p<0. 0001). For treatment of moderate to severe vasomotor symptoms, vulvar and vaginal atrophy associated with the menopause, the lowest dose and regimen that will control symptoms should be chosen and medication should be discontinued as promptly as possible.

The recommended treatment for atrophic vaginitis in postmenopausal women includes:

• Ospemifene (PO): 60 mg daily, as it has been shown to improve moderate to severe symptoms of vulvar and vaginal atrophy, including dyspareunia 2.
• Estradiol (PV): The usual dosage is 10 to 20 mg every four weeks, and the lowest dose and regimen that will control symptoms should be chosen and medication should be discontinued as promptly as possible 3.

From the Research

Treatment Options for Atrophic Vaginitis in Postmenopausal Women

• Local estrogen replacement therapy is a recommended treatment for atrophic vaginitis in postmenopausal women, as it has been shown to be effective and safe 4.
• Low-dose 17beta-estradiol vaginal tablets have been found to improve symptoms of atrophic vaginitis with minimal incidence of adverse reactions 4.
• Ospemifene, an estrogen agonist/antagonist, is also an option for the treatment of moderate-to-severe dyspareunia associated with vulvovaginal atrophy in postmenopausal women 5.
• Intra-vaginal oestrogenic preparations, such as creams, pessaries, tablets, and the oestradiol-releasing ring, have been found to improve symptoms of vaginal atrophy in postmenopausal women when compared to placebo 6.

Comparison of Treatment Options

• There is no evidence of a difference in efficacy between the various intra-vaginal oestrogenic preparations when compared with each other 6.
• Oestrogen cream may be associated with an increase in endometrial thickness compared to oestrogen ring, possibly due to the higher doses of cream used 6.
• Vaginal estrogen administration results in lower plasma estrogen concentrations compared to oral administration 7.

Barriers to Treatment

• Despite the availability of effective treatment options, many women with atrophic vaginitis may be hesitant to initiate hormonal treatment due to safety concerns or embarrassment 8.
• Healthcare professionals should initiate and encourage frank and candid conversation about vaginal atrophy at annual visits and provide follow-up and treatment as needed 8.