Clinical update on the use of ospemifene in the treatment of severe symptomatic vulvar and vaginal atrophy

Figures & data

Figure 1 Ospemifene 60 mg Phase III program.

Table 1 Summary of 60 mg ospemifene-related adverse events

Adverse events	Number (%) of patients
	Phase II/III placebo-controlled studies^Citation78^–^Citation84
	Placebo (n=958)	60 mg ospemifene (1,242)	Frequency
Infections and infestations
Vulvovaginal candidiasis/mycotic infections	10 (0.8)	91 (7.3)	Frequent (≥1/100 to <1/10)
Vasomotor disorders
Hot flashes	25 (2.6)	93 (7.5)	Frequent (≥1/100 to <1/10)
Musculoskeletal and connective tissue disorders
Muscle spasms	9 (0.9)	40 (3.2)	Frequent (≥1/100 to <1/10)
Reproductive system and breast disorders
Vaginal and genital flow	4 (0.4)	63 (5.1)	Frequent (≥1/100 to <1/10)
Endometrial hypertrophy	0 (0.0)	9 (0.7)	Nonfrequent (≥1/1,000 to <1/100)

ChristiansenCChesnutCH3rdAdachiJDSafety of bazedoxifene in a randomized, double-blind, placebo- and active-controlled Phase 3 study of postmenopausal women with osteoporosisBMC Musculoskelet Disord20101113020569451

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European Medicines AgencySenshio Summary of Product CharacteristicsEMA2015 Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002780/WC500182775.pdfAccessed June 1, 2016

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