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Ultra-low Dose Estradiol in Menopausal Women with Vaginal Atrophy

Post-Women's Health Initiative, hormone therapy in systemic usage has been on the decline, while local usage has increased. Estradiol is the most effective treatment for moderate to severe symptoms of vular and vaginal atrophy, and Estradiol 10ug vaginal tablets have been shown to be effective for treatment of atrophic vaginitis due to menopause.

Expanding upon this, researchers hoped to gauge the endometrial safety and clinical pharmacokinetics of this treatment for menopausal women with vaginal atrophy.

They found that:

  • estradiol 10ug vaginal tablets are an effective treatment for vaginal atrophy in menopausal women;
  • the pharmacokinetic analysis showed initial increasing systemic levels of E2 on day one;
  • mean endometrial thickness at the end of study (12 months) remained unchanged compared to baseline measures;
  • the incidence rate of hyperplasia and carcinoma was .52%, but treatment for up to one years was not associated with increased risk.

A discussion arose at the end of the presentation about the effects of this ultra-low dose therapy on breast cancer patients, and the authors indicated that they were hoping that their study would “get FDA approval for this dose for post-breast cancer patients,” but were unable, and it is currently not indicated or approved for that use.

One member of the audience wondered whether, because post-menopausal bone is sensitive to estrogen, the research paid any attention to changes in bone resorption. Unfortunately, they gathered no such information in this particular analysis, but commented that, anecdotally, their feeling was they “didn’t see any changes in the patient.”

In response to a question about incidences of basal motor symptomatology, the authors commented that they couldn’t address that concern because it wasn’t an exclusion criteria, nor did they ask about it.

Finally, there were zero incidences of spotting or bleeding over the course of the study.