For what indications is vaginal hormone therapy indicated?

Indications for Vaginal Hormone Therapy

Vaginal hormone therapy is primarily indicated for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with menopause, including vaginal dryness and dyspareunia (painful intercourse). 1, 2

Primary Indications

• Moderate to severe dyspareunia (painful intercourse) due to vulvar and vaginal atrophy associated with menopause 2
• Moderate to severe vaginal dryness due to vulvar and vaginal atrophy associated with menopause 2
• Symptoms of vaginal atrophy including itching, burning, irritation, and discomfort 3, 4
• Recurrent urinary tract infections in postmenopausal women by restoring vaginal microbiome and reducing vaginal atrophy 5

Treatment Algorithm Based on Symptom Severity

First-Line Approach

• For mild symptoms, non-hormonal options should be tried first:
  • Water-based lubricants for sexual activity 3
  • Vaginal moisturizers applied 3-5 times weekly for daily comfort 3

Second-Line Approach

• For moderate to severe symptoms or when non-hormonal options fail:
  • Low-dose vaginal estrogen (creams, tablets, rings) 3
  • Vaginal DHEA (prasterone) for dyspareunia and vaginal dryness 3, 6
  • Ospemifene (oral selective estrogen receptor modulator) for dyspareunia and vaginal dryness in women without a history of hormone-sensitive cancers 3, 2

Special Considerations by Patient Population

Women Without a Uterus

• Estrogen-only therapy is recommended due to its more favorable risk/benefit profile 5
• No need for progestogen supplementation 5
• Available as vaginal rings, vaginal tablets, and vaginal creams 5

Women With Intact Uterus

• Low-dose vaginal estrogen preparations can be used without additional progestogen due to minimal systemic absorption 7
• Higher-dose preparations may require progestogen to protect the endometrium 8

Women With History of Breast Cancer

• Non-hormonal options should be tried first 3
• For women with hormone-positive breast cancer who are symptomatic and not responding to conservative measures, low-dose vaginal estrogen can be considered only after thorough discussion of risks and benefits 3
• For women on aromatase inhibitors who have not responded to previous treatments, vaginal DHEA (prasterone) may be offered 3
• Ospemifene should not be used in women with history of hormone-dependent neoplasia 2

Contraindications

• Undiagnosed abnormal genital bleeding 2
• Known or suspected estrogen-dependent neoplasia 2
• Active deep vein thrombosis, pulmonary embolism, or history of these conditions 2
• Active arterial thromboembolic disease (stroke, myocardial infarction) or history of these conditions 2
• Known hypersensitivity to the active ingredients 2
• Known or suspected pregnancy 2

Efficacy Considerations

• Vaginal estrogen is the most effective treatment for vaginal dryness leading to sexual dysfunction 3
• No significant differences in efficacy have been observed between different vaginal estrogen preparations (creams, tablets, rings) 7
• Vaginal DHEA has been shown to significantly improve sexual desire, arousal, pain, and overall sexual function 3, 6
• Ospemifene effectively treats vaginal dryness and dyspareunia in postmenopausal women 3, 2

Safety Considerations

• Low-dose vaginal estrogen has minimal systemic absorption with no concerning safety signals regarding risk of stroke, venous thromboembolism, or cancer in large studies 5
• For women with a history of estrogen-dependent breast cancer, a large cohort study of almost 50,000 patients followed for up to 20 years showed no evidence of higher risk of breast cancer–specific mortality in those using vaginal estrogen 3
• DHEA should be used with caution in survivors receiving aromatase inhibitor therapy 3

By following this evidence-based approach to vaginal hormone therapy, clinicians can effectively address the symptoms of vulvar and vaginal atrophy while minimizing potential risks.