A comparative study of safety and efficacy of continuous low dose oestradiol released from a vaginal ring compared with conjugated equine oestrogen vaginal cream in the treatment of postmenopausal urogenital atrophy

Abstract

Objective To compare the safety, efficacy and acceptability of a continuous low dose oestradiol releasing vaginal ring with conjugated equine oestrogen vaginal cream in the treatment of postmenopausal urogenital atrophy. Design An open, parallel, comparative multicentre trial. Setting Sydney and Melbourne, Australia. Participants and Interventions One hundred and ninety‐four postmenopausal women with symptoms and signs of urogenital atrophy were randomised on a 2:1 basis to 12 weeks of treatment with an oestrogen vaginal ring versus an oestrogen cream. Main outcome measures and results Equivalence (95% CI) was demonstrated between the two treatments for relief of vaginal dryness and dyspareunia, resolution of atrophic signs, improvement in vaginal mucosal maturation indices and reduction in vaginal pH. No significant difference was demonstrated in endometrial response to a progestogen challenge test and equivalence was demonstrated in the incidence of intercurrent bleeding episodes. The vaginal ring was significantly more acceptable than the cream (P < 0.0001), and was preferred to the cream (P < 0.001). Conclusion With equivalent efficacy and safety and superior acceptability to vaginal cream, the low dose oestradiol vaginal ring is an advance in vaginal delivery systems for the treatment of urogenital atrophy.

Microbicide vaginal rings: Technological challenges and clinical development

“…Numerous studies have reported high user acceptability of VRs for contraception and estrogen replacement therapy [29,30,[33][34][35]39,[197][198][199][200][201][202]. Of particular significance is the strong preference for rings over semi-solid systems [34,197] which should hopefully extend to vaginal microbicide products, since high levels of user acceptability/satisfaction generally correlate with user adherence.…”

Vaginal Hormone Therapy for Urogenital and Menopausal Symptoms

“…113 Compared with estradiol inserts (pessaries), the ring was equally efficacious in alleviating dysuria (76%), urge incontinence (58%), and stress incontinence (53%), but was much more acceptable (60% v 14%). 114 Patients preferred the vaginal ring to conjugated estrogen 115 or estriol cream 116 as well. Recurrent UTIs were less frequent in women using the ring compared with nonusers.…”

“…120 Felding et al 158 documented proliferative endometrial changes in two of 12 women using the 25-mg tablet for only 3 weeks. Ayton et al 115 reported that two of 194 women using the 8-mg estradiol ring for 12 weeks had bleeding and showed proliferative endometrium on biopsy. Five percent of the urogenital ring users had proliferation in the North American safety trial, with one hyperplasia detected in an endometrial polyp compared with 10% of conjugated equine estrogen cream users who showed proliferative changes but no hyperplasia at 12 weeks.…”

Therapy of Female Sexual Dysfunction

“…been shown to have a role in decreasing dryness, urinary urgency and dyspareunia [8,26]. Estrogen therapy has also been shown in a double blind randomised placebo controlled trial of bilaterally oophorectomised women to significantly improve women's sexual interest, arousal, and orgasm but did not change the frequency of sexual intercourse [34].…”