OBJECTIVE: To compare serum 17beta-estradiol (E2), estrone (E1), estrone sulfate, follicle-stimulating hormone, luteinizing hormone, sex hormone-binding globulin, vaginal pH, and the vaginal maturation indices in women using a low-dosetransdermal patch releasing 14 microg of E2 per day and a vaginal ring releasing 7.5 microg of E2 per day. DESIGN:Twenty-four postmenopausal women were randomly assigned to either the patch (n = 12) or the ring (n = 12) for a 12-week study period. Serum E2, E1, estrone sulfate, follicle-stimulating hormone, luteinizing hormone, and sex hormone-binding globulin were measured by immunoassay at baseline and 6 and 12 weeks. Vaginal pH was determined at baseline and 6 and 12 weeks. Vaginal cytologic examinations for vaginal maturation index were done at baseline and 12 weeks. RESULTS:Twenty women completed the study. The patch significantly increased serum E1 and E2 levels at 6 and 12 weeks (P < 0.01); there was no significant increase in serum E1 and E2 levels with the ring. Both the patch and the ring significantly reduced vaginal pH at 6 (P < 0.001) and 12 (P < 0.001) weeks and significantly reduced the percentage of vaginal parabasal cells at 12 weeks with no significant difference between the two groups. Both preparations increased the proportion of superficial cells; the increase was significant only with the patch (P = 0.04). CONCLUSIONS: A transdermal E2 skin patch releasing 14 microg of E2 per day had an effect on vaginal pH and vaginal maturation indices similar to that of a vaginal E2 ring releasing 7.5 microg of E2 per day. Therefore, this patch is likely to relieve symptoms of vulvovaginal atrophy.
RCT Entities:
OBJECTIVE: To compare serum 17beta-estradiol (E2), estrone (E1), estrone sulfate, follicle-stimulating hormone, luteinizing hormone, sex hormone-binding globulin, vaginal pH, and the vaginal maturation indices in women using a low-dose transdermal patch releasing 14 microg of E2 per day and a vaginal ring releasing 7.5 microg of E2 per day. DESIGN: Twenty-four postmenopausal women were randomly assigned to either the patch (n = 12) or the ring (n = 12) for a 12-week study period. Serum E2, E1, estrone sulfate, follicle-stimulating hormone, luteinizing hormone, and sex hormone-binding globulin were measured by immunoassay at baseline and 6 and 12 weeks. Vaginal pH was determined at baseline and 6 and 12 weeks. Vaginal cytologic examinations for vaginal maturation index were done at baseline and 12 weeks. RESULTS: Twenty women completed the study. The patch significantly increased serum E1 and E2 levels at 6 and 12 weeks (P < 0.01); there was no significant increase in serum E1 and E2 levels with the ring. Both the patch and the ring significantly reduced vaginal pH at 6 (P < 0.001) and 12 (P < 0.001) weeks and significantly reduced the percentage of vaginal parabasal cells at 12 weeks with no significant difference between the two groups. Both preparations increased the proportion of superficial cells; the increase was significant only with the patch (P = 0.04). CONCLUSIONS: A transdermal E2 skin patch releasing 14 microg of E2 per day had an effect on vaginal pH and vaginal maturation indices similar to that of a vaginal E2 ring releasing 7.5 microg of E2 per day. Therefore, this patch is likely to relieve symptoms of vulvovaginal atrophy.
Authors: Alison J Huang; Steven E Gregorich; Miriam Kuppermann; Sanae Nakagawa; Stephen K Van Den Eeden; Jeanette S Brown; Holly E Richter; Louise C Walter; David Thom; Anita L Stewart Journal: Menopause Date: 2015-02 Impact factor: 2.953
Authors: Christopher McConville; James M Smith; Clare F McCoy; Priya Srinivasan; James Mitchell; Angela Holder; Ron A Otten; Salvatore Butera; Gustavo F Doncel; David R Friend; R Karl Malcolm Journal: Drug Deliv Transl Res Date: 2015-02 Impact factor: 4.617
Authors: Kathleen Ridgeway; Elizabeth T Montgomery; Kevin Smith; Kristine Torjesen; Ariane van der Straten; Sharon L Achilles; Jennifer B Griffin Journal: Contraception Date: 2021-10-10 Impact factor: 3.051
Authors: David F Archer; Ginger D Constantine; James A Simon; Harvey Kushner; Philip Mayer; Brian Bernick; Shelli Graham; Sebastian Mirkin Journal: Menopause Date: 2017-05 Impact factor: 2.953