Ospemifene 12-month safety and efficacy in postmenopausal women with vulvar and vaginal atrophy was written by Goldstein, S. R.;Bachmann, G. A.;Koninckx, P. R.;Lin, V. H.;Portman, D. J.;Ylikorkala, O.. And the article was included in Climacteric in 2014.Quality Control of (Z)-2-(4-(4-Chloro-1,2-diphenylbut-1-en-1-yl)phenoxy)ethan-1-ol This article mentions the following:
Objective: Assessment of 12-mo safety of ospemifene 60 mg/day for treatment of postmenopausal women with vulvar and vaginal atrophy (VVA). Methods: In this 52-wk, randomized, double-blind, placebo-controlled, parallel-group study, women 40-80 years with VVA and an intact uterus were randomized 6 : 1 to ospemifene 60 mg/day or placebo. The primary objective was 12-mo safety, particularly endometrial; 12-wk efficacy was assessed. Safety assessments included endometrial histol. and thickness, and breast and gynecol. examinations Efficacy evaluations included changes from baseline to week 12 in percentage of superficial and parabasal cells and vaginal pH. Results: Of 426 randomized subjects, 81.9% (n =349) completed the study with adverse events the most common reason for discontinuation (ospemifene 9.5%; placebo 3.9%). Most (88%) treatment-emergent adverse events with ospemifene were considered mild or moderate. Three cases (1.0%) of active proliferation were observed in the ospemifene group. For one, active proliferation was seen at end of study week 52, and diagnosed as simple hyperplasia without atypia on follow-up biopsy 3 mo after the last dose. This subsequently resolved with progestogen treatment and dilatation and curettage. In six subjects (five ospemifene (1.4%), one placebo (1.6%)) endometrial polyps were found (histopathol.); however, only one (ospemifene) was confirmed as a true polyp during addnl. expert review. Endometrial histol. showed no evidence of carcinoma. Statistically significant improvements were seen for all primary and secondary efficacy measures and were sustained through week 52 with ospemifene vs. placebo. Conclusions: The findings of this 52-wk study confirm the tolerance and efficacy of oral ospemifene previously reported in short- and long-term studies. In the experiment, the researchers used many compounds, for example, (Z)-2-(4-(4-Chloro-1,2-diphenylbut-1-en-1-yl)phenoxy)ethan-1-ol (cas: 128607-22-7Quality Control of (Z)-2-(4-(4-Chloro-1,2-diphenylbut-1-en-1-yl)phenoxy)ethan-1-ol).
(Z)-2-(4-(4-Chloro-1,2-diphenylbut-1-en-1-yl)phenoxy)ethan-1-ol (cas: 128607-22-7) belongs to alcohols. Similar to water, an alcohol can be pictured as having an sp3 hybridized tetrahedral oxygen atom with nonbonding pairs of electrons occupying two of the four sp3 hybrid orbitals. The most common reactions of alcohols can be classified as oxidation, dehydration, substitution, esterification, and reactions of alkoxides.Quality Control of (Z)-2-(4-(4-Chloro-1,2-diphenylbut-1-en-1-yl)phenoxy)ethan-1-ol
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