*OSPHENA should be prescribed for the shortest duration consistent with treatment goals and risks for the individual woman.
Image for illustrative purposes only. Individual results may vary.
In contrast to postmenopausal vasomotor symptoms – hot flushes, cold or night sweats – that usually improve over time, symptoms of VVA, including moderate to severe dyspareunia, persist throughout postmenopause.2,3
Note: Image is for illustrative purposes only. The occurrence and intensity of menopausal symptoms vary widely between women and depend on genetic, environmental, racial, lifestyle, and anthropometric factors. Black race, smoking, and overweight–in particular, central obesity–increase the prevalence and severity of vasomotor symptoms.3
Women enter menopause at an average age of about 52 years
and they have a life expectancy of approximately 82 years.4,5
In postmenopausal women, declining estrogen levels significantly alter vaginal physiology and can lead to
moderate to severe dyspareunia, a symptom of vulvar
and vaginal atrophy (VVA).4,6,7
Some women may be sexually active for decades after menopause.8
Because some women are living longer and often continue to be sexually active after menopause, an effective
treatment for moderate to severe dyspareunia could benefit a great number of postmenopausal women.9
References: 1. Kingsberg SA, Wysocki S, Magnus L, Krychman ML. Vulvar and vaginal atrophy in postmenopausal women: findings from the REVIVE (Real Women’s VIews of Treatment Options for Menopausal Vaginal ChangEs) survey. J Sex Med. 2013;10(7):1790-1799. 2. North American Menopause Society. Management of symptomatic vulvovaginal atrophy: 2013 position statement of The North American Menopause Society. Menopause. 2013;20(9):888-902. 3. Davis SR, Lambrinoudaki I, Lumsden M, et al. Menopause. Nat Rev Dis Primer. 2015;15004. doi:10.1038/nrdp.2015.4. 4. Shifren JL, Gass ML. NMS Recommendations for Clinical Care of Midlife Women Working Group. Menopause. 2014;21(10):1038-1062. 5. U.S. National Center for Health Statistics Reports. Census Bureau. Table 105. Life expectancy by sex, age, and race: 2008. Statistical Abstract of the United States: 2012. US Census Bureau Web site. https://www.census.gov/prod/2011pubs/12statab/visitat.pdf. Accessed March 26, 2015. 6. Archer DF, Carr BR, Pinkerton JV, et al. Effects of ospemifene on the female reproductive and urinary tracts: translation from preclinical models into clinical evidence. Menopause. 2015;22(7):1-11. 7. Simon JA. Vulvovaginal atrophy: What is it, what causes it? OBG Management. 2015;(suppl):1-2. 8. Lindau ST, Schumm LP, Laumann EO, et al. A study of sexuality and health among older adults in the United States. N Engl J Med. 2007;357:762-774. 9. Portman DJ, Bachmann GA, Simon JA; Ospemifene Study Group. Ospemifene, a novel selective estrogen receptor modulator for treating dyspareunia associated with postmenopausal vulvar and vaginal atrophy. Menopause. 2013;20(6):623-630.
significant relief of
moderate to severe
dyspareunia due to
menopause observed at
Week 12 (P<0.0001)1
OSPHENA is proven to
as observed at Week 126
in vaginal epithelium‡6
*SERM=selective estrogen receptor modulator.
†OSPHENA should be prescribed for the shortest duration consistent with treatment goals and risks for the individual woman.
‡Superficial and parabasal cells, pH.
§OSPHENA was studied in a 52-week randomized, double-blind, placebo-controlled, long-term safety study conducted with 2 treatment groups: 60 mg (n=363) and placebo (n=63).
References: 1. Osphena [package insert]. Florham Park, NJ: Shionogi Inc; 2015. 2. Archer DF, Carr BR, Pinkerton JV, et al. Effects of ospemifene on the female reproductive and urinary tracts: translation from preclinical models into clinical evidence. Menopause. 2015;22(7):1-11. 3. Kangas L, Unkila M. Tissue selectivity of ospemifene: pharmacologic profile and clinical implications. Steroids. 2013;78:1273-1280. 4. ACOG Practice Bullet Number 141: Management of menopausal symptoms. Practice Bulletin No. 141. American College of Obstetricians and Gynecologists. Obstet Gynecol. 2014:123(1):202-216. 5. North American Menopause Society. Management of symptomatic vulvovaginal atrophy: 2013 position statement of the North American Menopause Society. Menopause. 2013;20(9):888-902. 6. Data on file. Shionogi Inc.
experienced an improvement in moderate to severe dyspareunia at the Week 12
72% (n=110) vs placebo 54% (n=113) (P=0.0012)1
Dyspareunia severity score 12-week mean change from baseline vs placebo2
vs 33% placebo
OSPHENA: -1.39 (n=110)
Placebo: -0.89 (n=113)
vs 44% placebo
OSPHENA: -1.55 (n=301)
Placebo: -1.19 (n=297)
Study Design: Two 12-week, randomized, double-blind, placebo-controlled, parallel-group efficacy studies in 1745 generally healthy postmenopausal women. Coprimary efficacy endpoints for both clinical studies included: a mean change from baseline to Week 12 for percentage of superficial cells on a vaginal smear, percentage of parabasal cells on a vaginal smear, vaginal pH, and most bothersome symptom of VVA (moderate to severe dyspareunia) self-reported by the patient.
Statistically superior improvements at Week 12 clinical assessment vs placebo1
Study Design: 12 week, randomized, double blind, placebo controlled, parallel group efficacy study included OSPHENA 60 mg (n=282) and placebo (n=268).
Study Design: 12 week, randomized, double blind, placebo controlled, parallel group efficacy study included Osphena 60 mg (n=282) and placebo (n=268).
(percentage of cells at Week 52)1
Click a button to see physiological change.
*OSPHENA was studied in a 52-week randomized, double-blind, placebo-controlled, long-term safety study that also was conducted with 2 treatment groups:
OSPHENA 60 mg (n=363) and placebo (n=63). OSPHENA should be prescribed for the shortest duration consistent with treatment goals and risks for the individual woman.
References: 1. Data on file. Shionogi Inc. 2. Osphena [package insert]. Florham Park, NJ: Shionogi Inc; 2015.
*409 postmenopausal women were studied for up to 52 weeks
|Adverse reactions in clinical trials reported at a frequency of ≥1% and
more common in the OSPHENA® 60-mg group1
|OSPHENA 60 mg
|Vascular Disorders||Hot Flush||7.5%||2.6%|
and Breast Disorders
Connective Tissue Disorders
|Skin and Subcutaneous
References 1. Osphena [package insert]. Florham Park, NJ: Shionogi Inc; 2015. 2. Data on file. Shionogi Inc.
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