A randomized, multicenter, double-blind study to evaluate the safety and efficacy of estradiol vaginal cream 0.003% in postmenopausal women with dyspareunia as the most bothersome symptom.
Menopause
; 25(2): 133-138, 2018 02.
Article
em En
| MEDLINE
| ID: mdl-28926514
ABSTRACT
OBJECTIVE:
Vulvovaginal atrophy (VVA) is characterized by vaginal changes, dyspareunia, and itching/irritation. Efficacy and safety of a lower-dose estradiol vaginal cream (0.003%) were evaluated in postmenopausal women with VVA-related dyspareunia.METHODS:
This was a phase 3, randomized, double-blind, placebo-controlled study. Sexually active postmenopausal women with moderate-severe dyspareunia as the most bothersome symptom, ≤5% vaginal superficial cells, and vaginal pH >5.0 were randomized (11) to 0.003% estradiol vaginal cream (15âµg estradiol; 0.5âg cream) or placebo (0.5âg cream) applied daily for 2 weeks followed by three applications/week for 10 weeks. Coprimary outcomes were changes in dyspareunia severity, vaginal cytology, and vaginal pH from baseline to final assessment. Additional efficacy outcomes and safety were assessed.RESULTS:
A total of 550 participants (average age, 58 y) were randomized. Compared with placebo, estradiol reduced dyspareunia severity (mean change from baselineâ±âSD -1.5â±â1.0 estradiol vs -1.2â±â0.9 placebo), decreased vaginal pH (-1.36â±â0.89 vs -0.53â±â0.92), and improved vaginal cytology (percentage superficial and parabasal cells 10.1â±â16.7 vs 1.4â±â6.1 and -48.5â±â45.1 vs -14.6â±â39.6; Pâ<â0.001, all) at the final assessment. In addition, estradiol decreased dyspareunia severity at weeks 8 and 12, vaginal/vulvar irritation/itching at weeks 4 and 12, and dryness at week 12 versus placebo (Pâ<â0.01, all). VVA severity, pH, and cytology improved at week 12 with estradiol versus placebo (Pâ<â0.001, all). Vulvovaginal mycotic infections were more frequent with estradiol. One serious event leading to discontinuation occurred with estradiol. No deaths occurred.CONCLUSIONS:
Lower-dose estradiol vaginal cream (0.003%) dosed three applications/week is an effective and well-tolerated treatment for VVA-related dyspareunia.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Vagina
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Cremes, Espumas e Géis Vaginais
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Vulva
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Dispareunia
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Estradiol
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Estrogênios
Tipo de estudo:
Clinical_trials
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Diagnostic_studies
Limite:
Aged
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Female
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Humans
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Middle aged
Idioma:
En
Revista:
Menopause
Assunto da revista:
GINECOLOGIA
Ano de publicação:
2018
Tipo de documento:
Article
País de publicação:
EEUU
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ESTADOS UNIDOS
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ESTADOS UNIDOS DA AMERICA
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EUA
/
UNITED STATES
/
UNITED STATES OF AMERICA
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US
/
USA