James Simon1, David Portman2, R Garn Mabey3. 1. The George Washington University School of Medicine, 1850 M Street NW, Suite 450, Washington, DC 20036, United States. Electronic address: jsimon@jamesasimonmd.com. 2. Columbus Center for Women's Health Research, 99 North Brice Road, Suite 120, Columbus, OH 43213, United States. Electronic address: davidportman@earthlink.net. 3. Gynecology, 2881 North Tenaya Way, Las Vegas, NV 89128, United States. Electronic address: garnmabey@gmail.com.
Abstract
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 receivedoral 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 12-week treatment period totaled up to 64 weeks of ospemifene exposure. A 4-week posttreatment follow-up ensued (68 weeks total). MAIN OUTCOME MEASURES: Safety assessments included adverse events, laboratory studies, physical and gynecologic examination, vital signs, breast palpation, and mammography. RESULTS: Most treatment-emergent adverse events (TEAEs) during the extension study were mild or moderate in severity. The most common TEAE related to study drug was hot flushes (10%; leading to discontinuation for 2% of patients). One serious TEAE, a non-ST-elevation myocardial infarction in a patient with pre-existing cardiac disease, was considered possibly related to study medication. One mild breast-related TEAE, considered unrelated to study drug, was ongoing at study completion. There were no instances of pelvic organ prolapse, incontinence, venous thromboembolism, fractures, breast cancers or death. No clinically significant adverse changes were observed in other safety parameters. CONCLUSIONS:Ospemifene is clinically safe and generally well tolerated in postmenopausal patients with dyspareunia, a symptom of VVA.
RCT Entities:
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 12-week treatment period totaled up to 64 weeks of ospemifene exposure. A 4-week posttreatment follow-up ensued (68 weeks total). MAIN OUTCOME MEASURES: Safety assessments included adverse events, laboratory studies, physical and gynecologic examination, vital signs, breast palpation, and mammography. RESULTS: Most treatment-emergent adverse events (TEAEs) during the extension study were mild or moderate in severity. The most common TEAE related to study drug was hot flushes (10%; leading to discontinuation for 2% of patients). One serious TEAE, a non-ST-elevation myocardial infarction in a patient with pre-existing cardiac disease, was considered possibly related to study medication. One mild breast-related TEAE, considered unrelated to study drug, was ongoing at study completion. There were no instances of pelvic organ prolapse, incontinence, venous thromboembolism, fractures, breast cancers or death. No clinically significant adverse changes were observed in other safety parameters. CONCLUSIONS:Ospemifene is clinically safe and generally well tolerated in postmenopausal patients with dyspareunia, a symptom of VVA.