OBJECTIVE: The aim of this study was to evaluate the efficacy and safety of low-dose conjugated estrogens (CE) cream for treatment of atrophic vaginitis. METHODS:Postmenopausal women (N = 423) with moderate-to-severe vaginal atrophy were randomized to CE cream 0.3 mg or placebo once daily (21 days on/7 days off) or twice weekly for 12 weeks, followed by open-label treatment with CE cream for 40 weeks consistent with their prior regimen. Primary endpoints were changes in vaginal maturation index (VMI; percentage of superficial cells), vaginal pH, and severity of participant-reported most bothersome symptom (vaginal dryness, itching, burning, or dyspareunia) at week 12. Endometrial safety was assessed by transvaginal ultrasound and endometrial biopsy for 52 weeks. RESULTS: At week 12, improvements in VMI with daily and twice-weekly use of low-dose CE cream (27.9% and 25.8%, respectively) were significantly greater compared with placebo (3.0% and 1.0%, respectively; P < 0.001). Improvements in vaginal pH with daily and twice-weekly CE cream (-1.6 for both) were also significantly greater relative to placebo (-0.4 and -0.3, respectively; P < 0.001). VMI and vaginal pH responses were sustained through 52 weeks. Both CE cream regimens significantly reduced most bothersome symptom scores compared with placebo (P < or = 0.001), including those for dyspareunia (P < or = 0.01). There was no report of endometrial hyperplasia or carcinoma. Adverse events occurred with similar frequency among the active and placebo groups during the double-blind phase. CONCLUSIONS: Daily and twice-weekly use of low-dose CE cream was equally effective in relieving symptoms of vulvovaginal atrophy. Both regimens showed endometrial safety and sustained efficacy during 1 year of therapy.
RCT Entities:
OBJECTIVE: The aim of this study was to evaluate the efficacy and safety of low-dose conjugated estrogens (CE) cream for treatment of atrophic vaginitis. METHODS: Postmenopausal women (N = 423) with moderate-to-severe vaginal atrophy were randomized to CE cream 0.3 mg or placebo once daily (21 days on/7 days off) or twice weekly for 12 weeks, followed by open-label treatment with CE cream for 40 weeks consistent with their prior regimen. Primary endpoints were changes in vaginal maturation index (VMI; percentage of superficial cells), vaginal pH, and severity of participant-reported most bothersome symptom (vaginal dryness, itching, burning, or dyspareunia) at week 12. Endometrial safety was assessed by transvaginal ultrasound and endometrial biopsy for 52 weeks. RESULTS: At week 12, improvements in VMI with daily and twice-weekly use of low-dose CE cream (27.9% and 25.8%, respectively) were significantly greater compared with placebo (3.0% and 1.0%, respectively; P < 0.001). Improvements in vaginal pH with daily and twice-weekly CE cream (-1.6 for both) were also significantly greater relative to placebo (-0.4 and -0.3, respectively; P < 0.001). VMI and vaginal pH responses were sustained through 52 weeks. Both CE cream regimens significantly reduced most bothersome symptom scores compared with placebo (P < or = 0.001), including those for dyspareunia (P < or = 0.01). There was no report of endometrial hyperplasia or carcinoma. Adverse events occurred with similar frequency among the active and placebo groups during the double-blind phase. CONCLUSIONS: Daily and twice-weekly use of low-dose CE cream was equally effective in relieving symptoms of vulvovaginal atrophy. Both regimens showed endometrial safety and sustained efficacy during 1 year of therapy.
Authors: Caroline M Mitchell; Sujatha Srinivasan; Anna Plantinga; Michael C Wu; Susan D Reed; Katherine A Guthrie; Andrea Z LaCroix; Tina Fiedler; Matthew Munch; Congzhou Liu; Noah G Hoffman; Ian A Blair; Katherine Newton; Ellen W Freeman; Hadine Joffe; Lee Cohen; David N Fredricks Journal: Menopause Date: 2018-05 Impact factor: 2.953
Authors: Caroline M Mitchell; Susan D Reed; Susan Diem; Joseph C Larson; Katherine M Newton; Kristine E Ensrud; Andrea Z LaCroix; Bette Caan; Katherine A Guthrie Journal: JAMA Intern Med Date: 2018-05-01 Impact factor: 21.873
Authors: Susan D Reed; Andrea Z LaCroix; Garnet L Anderson; Kristine E Ensrud; Bette Caan; Janet S Carpenter; Lee Cohen; Susan J Diem; Ellen W Freeman; Hadine Joffe; Joseph C Larson; Susan M McCurry; Caroline M Mitchell; Katherine M Newton; Barbara Sternfeld; Katherine A Guthrie Journal: Menopause Date: 2020-04 Impact factor: 2.953
Authors: David D Rahn; Meadow M Good; Shayzreen M Roshanravan; Haolin Shi; Joseph I Schaffer; Ravinder J Singh; R Ann Word Journal: J Clin Endocrinol Metab Date: 2014-06-20 Impact factor: 5.958