Endometrial Safety of Ultra-Low-Dose Estradiol Vaginal Tablets

Abstract

II.

Investigation of Women with Postmenopausal Uterine Bleeding: Clinical Practice Recommendations

“…These increases were not seen with continuous progestin regimens, including the use of the intrauterine progestin releasing system. There is relatively recent evidence that ultralow doses of unopposed estrogen may not increase the incidence of endometrial carcinoma, but these preparations are not yet in widespread use 30,31 (Class 3). Furthermore, there is good evidence that even doses as low as 0.3 mg/day of unopposed equine estrogens are associated with an increased risk of endometrial hyperplasia 25 (Class 1a).…”

Update on management of genitourinary syndrome of menopause: A practical guide

“…Absorption depends on the dose used and the degree of vaginal atrophy. Thus plasma estrogen levels do not exceed the normal postmenopausal range of ≤ 20 pg/ml with long term use of 10mcg estradiol tablets and does not increase the risk of endometrial hyperplasia and carcinoma [5,21,24]. On the other hand, absorption may be higher when treatment is initiated as the vaginal epithelium is thin and atrophic.…”

EMAS clinical guide: Low-dose vaginal estrogens for postmenopausal vaginal atrophy

“…An analysis of endometrial histology was undertaken combining the two one year studies [7][8][9]. Both trials generated a combined 10-g E2-treated population of 541 individuals and 443 women had a biopsy performed at week 52: 85.6% were categorised as "atrophic endometrium", 12.6% had non-evaluable biopsy samples, 1.1% had polyps, and 0.2% were categorised as "weakly proliferative".…”