Weekly vaginal administration of tamoxifen for three months in postmenopausal women with vulvar and vaginal atrophy: a possible new treatment approach?

Abstract

An exploratory study was conducted recruiting four healthy postmenopausal women suffering from vulvar and vaginal atrophy (VVA). Subjects self-administered vaginal suppositories containing tamoxifen (20 mg). Subjects were instructed to insert one suppository vaginally once daily for one week and twice weekly over a period of three months. Vaginal pH and dryness scores using a visual analog scale (VAS) were recorded at enrollment and subsequent assessments were recorded using self-assessment questionnaires over a three-month period. Serum tamoxifen levels were measured after two months of suppository use. After three months, both vaginal pH and vaginal dryness symptoms showed significant improvement. Vaginal pH scores improved approximately 30% compared to baseline by completion of the study. Vaginal dryness scores improved approximately 63% compared to baseline. As expected, serum tamoxifen levels were negligible ranging from 1.0 ng/ml to 10.0 ng/ml determined after eight weeks on the treatment. The present results suggest that delivery of tamoxifen directly to the vaginal epithelium for the treatment of VVA may be a viable new treatment approach. Therefore, this route of administration may offer an important treatment modality for patients with a history of breast cancer, at risk for breast cancer, and who have hormone-receptor-positive breast cancer, including estrogen receptor-positive (ER-positive), and progesterone receptor-positive (PR-positive) in addition to node negative breast cancer.