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Long-Term Safety Of Ospemifene (52-Week Extension) In The Treatment Of Vulvar And Vaginal Atrophy In Hysterectomized Postmenopausal Women, James A. Simon, David J. Portman, R. Garn Mabey, The Ospemifene Study Group
Long-Term Safety Of Ospemifene (52-Week Extension) In The Treatment Of Vulvar And Vaginal Atrophy In Hysterectomized Postmenopausal Women, James A. Simon, David J. Portman, R. Garn Mabey, The Ospemifene Study Group
Obstetrics and Gynecology Faculty Publications
Objective
To examine the long-term safety of oral ospemifene, a non-estrogen tissue-selective estrogen agonist/antagonist, for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy (VVA) due to menopause.
Study design
This multicenter, long-term, open-label, safety extension study was conducted in women without a uterus aged 40–80 years (N = 301) who received oral ospemifene 60 mg/day for 52 weeks. Participants either continued their 60-mg/day ospemifene dose from the initial 12-week pivotal efficacy study or switched from blinded placebo or ospemifene 30 mg/day to open-label ospemifene 60 mg/day. The 52-week open-label extension period plus initial …