A ONE-YEAR MULTICENTER STUDY OF EFFICACY AND SAFETY OF A CONTINUOUS, LOW-DOSE, ESTRADIOL-RELEASING VAGINAL RING (ESTRING) IN POSTMENOPAUSALWOMEN WITH SYMPTOMS AND SIGNS OF UROGENITAL AGING

OBJECTIVE: We studied the efficacy, safety, and acceptability of an es tradiol-releasing (6.5 to 9.5 mu g per 24 hours) silicone vaginal ring (Estring) in postmenopausal women with symptoms and signs of urogenit al aging during a treatment period of 1 year. STUDY DESIGN: The study was open with blind analysis of vaginal cytologic testing. In addition to gynecologic examination, subjective symptoms were assessed and vag inal pH and urinary samples (for bacteriuria) were obtained before ins ertion of Estring. This procedure was repeated every 3 months up to 1 year's treatment, together with requests concerning acceptability and adverse experiences. At inclusion and end of Estring treatment, vagina l smears for evaluation of cytologic results were obtained. RESULTS: E string induced a high maturation value in the vaginal mucosa and resto red vaginal pH to levels normally seen in fertile women (<5.5). For mo st variables a 90% responder rate (proportion bf cured and improved pa tients) was found after 3 months and up to 1 year regarding subjective symptoms and objective signs of vaginal mucosal atrophy. Twenty-eight (20%) of 136 women withdrew from the study, 8 (6%) of them because of adverse events. Three women reported vaginal bleeding, none associate d with malignancy or endometrial proliferation. Ten (7%) reported vagi nal irritation, and in two cases vaginal ulcers were found. About 90% did not remove the ring during any of the 3-month treatment periods, a nd 78% used the four consecutive rings continuously up to 1 year. The ring was given a strong preference (p < 0.001) by patients with previo us experience of other administration forms. CONCLUSION: Estring repre sents a safe, highly effective, and very well-accepted administration form for long-term treatment of urogenital disorders caused by estroge n deficiency in postmenopausal women.