Estradiol/progesterone releasing vaginal rings for hormone replacement therapy in postmenopausal women

The objective was to determine the usefulness of estradiol (E2) and progest erone (P)-releasing vaginal rings in managing postmenopausal women with cli macteric symptoms. Two variants of rings were used for 4 months in 20 postm enopausal women. One identified as PI-002 (n=8) delivered 160 ug/day of E2 and 20 mg/day of P, while the other PI-003 (n=12) delivered the same amount of E2 and 10 mg/day P. Serum E2 levels average about 70 pg/mL, whereas mea n values of E1 were about 50 pg/mL. Mean values of P for PI-002 rings were 5 ng/mL, while those with PI-003 rings were 3.5 ng/mL. Remarkable decreases in the incidence of hot flashes were obtained, and mood scores were striki ngly improved even after only 2 weeks of use. The two variants of rings wer e similarly effective. 3 subjects experienced spontaneous expulsion of the ring. Although higher incidence of bleeding and spotting was noted among us ers with PI-002 rings, no subjects with PI-003 rings experienced either ble eding or spotting after 2 months of use. Increase in vaginal discharge was confined to the first 1.5 months of use. Ultrasound monitoring showed the e ndometrium to be uniformly <3mm thick during use. Thus, E2/P vaginal rings provide an alternative means of HRT with the advantages of long action over 4 months and uniform protection against endometrial hyperplasia.