Effect of ospemifene on moderate or severe symptoms of vulvar and vaginal atrophy
| Autor: | R. E. Nappi, T. J. de Villiers, Camil Castelo-Branco, James A. Simon, N. Bruyniks |
|---|---|
| Rok vydání: | 2015 |
| Předmět: |
Adult
Selective Estrogen Receptor Modulators randomized clinical trials medicine.medical_specialty Vaginal Diseases 030209 endocrinology & metabolism Placebo Article Vulva 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Vaginal disease Double-Blind Method Ospemifene Internal medicine ospemifene medicine Humans Aged Aged 80 and over Gynecology 030219 obstetrics & reproductive medicine business.industry Pruritus Obstetrics and Gynecology General Medicine Vulvar and vaginal atrophy Middle Aged medicine.disease Postmenopause Tamoxifen Dyspareunia Treatment Outcome medicine.anatomical_structure chemistry Selective estrogen receptor modulator Vagina Itching Original Article Female Vaginal atrophy Atrophy medicine.symptom business |
| Zdroj: | Climacteric |
| ISSN: | 1473-0804 1369-7137 |
| DOI: | 10.3109/13697137.2015.1113517 |
| Popis: | Objectives To determine whether assessment of all moderate-to-severe symptoms at baseline gives a more accurate evaluation of the treatment effect of ospemifene in vulvovaginal atrophy (VVA) than the most bothersome symptom (MBS) approach. Methods Data were pooled from two pivotal phase-III clinical trials evaluating the efficacy and safety of oral ospemifene 60 mg/day for the treatment of symptoms of VVA (n = 1463 subjects). Symptoms of vaginal dryness, dyspareunia, and vaginal and/or vulvar irritation/itching reported as moderate or severe at baseline were evaluated. Clinically relevant differences between ospemifene and placebo were analyzed using a four-point severity scoring system and presented as improvement, substantial improvement, or relief. Results Subjects in these studies reported statistically significant improvement, substantial improvement, and relief for vaginal dryness (p |
| Databáze: | OpenAIRE |
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