Ospemifene 12-month safety and efficacy in postmenopausal women with vulvar and vaginal atrophy
Identifieur interne : 000302 ( Main/Exploration ); précédent : 000301; suivant : 000303Ospemifene 12-month safety and efficacy in postmenopausal women with vulvar and vaginal atrophy
Auteurs : S. R. Goldstein ; G. A. Bachmann [États-Unis] ; P. R. Koninckx [Italie] ; V. H. Lin ; D. J. Portman [États-Unis] ; O. Ylikorkala [Finlande]Source :
- Climacteric [ 1369-7137 ] ; 2013.
Abstract
Assessment of 12-month safety of ospemifene 60 mg/day for treatment of postmenopausal women with vulvar and vaginal atrophy (VVA).
In this 52-week, 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-month safety, particularly endometrial; 12-week efficacy was assessed. Safety assessments included endometrial histology and thickness, and breast and gynecological examinations. Efficacy evaluations included changes from baseline to week 12 in percentage of superficial and parabasal cells and vaginal pH.
Of 426 randomized subjects, 81.9% (
The findings of this 52-week study confirm the tolerance and efficacy of oral ospemifene previously reported in short- and long-term studies.
Url:
DOI: 10.3109/13697137.2013.834493
PubMed: 23984673
PubMed Central: 3971738
Affiliations:
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R." last="Goldstein">S. R. Goldstein</name><affiliation><nlm:aff id="AF0001"></nlm:aff></affiliation></author><author><name sortKey="Bachmann, G A" sort="Bachmann, G A" uniqKey="Bachmann G" first="G. A." last="Bachmann">G. A. Bachmann</name><affiliation wicri:level="1"><nlm:aff id="AF0002"><institution>University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School</institution>,<addr-line>New Brunswick, NJ</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Koninckx, P R" sort="Koninckx, P R" uniqKey="Koninckx P" first="P. R." last="Koninckx">P. R. Koninckx</name><affiliation wicri:level="1"><nlm:aff id="AF0003"><institution>University of Leuven Belgium, Oxford, UK, and University of Sacro Cuore</institution>,<addr-line>Rome</addr-line>,<country>Italy</country></nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Lin, V H" sort="Lin, V H" uniqKey="Lin V" first="V. H." last="Lin">V. H. Lin</name><affiliation><nlm:aff id="AF0004"></nlm:aff></affiliation></author><author><name sortKey="Portman, D J" sort="Portman, D J" uniqKey="Portman D" first="D. J." last="Portman">D. J. Portman</name><affiliation wicri:level="1"><nlm:aff id="AF0005"><institution>Columbus Center for Women's Health Research</institution>,<addr-line>Columbus, OH</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Ylikorkala, O" sort="Ylikorkala, O" uniqKey="Ylikorkala O" first="O." last="Ylikorkala">O. Ylikorkala</name><affiliation wicri:level="1"><nlm:aff id="AF0006"><institution>Department of Obstetrics and Gynecology, Helsinki University Central Hospital</institution>,<addr-line>Helsinki</addr-line>,<country>Finland</country></nlm:aff><country xml:lang="fr">Finlande</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></analytic><series><title level="j">Climacteric</title><idno type="ISSN">1369-7137</idno><idno type="eISSN">1473-0804</idno><imprint><date when="2013">2013</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Objective</title><p> Assessment of 12-month safety of ospemifene 60 mg/day for treatment of postmenopausal women with vulvar and vaginal atrophy (VVA).</p></sec><sec sec-type="methods"><title>Methods</title><p> In this 52-week, 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-month safety, particularly endometrial; 12-week efficacy was assessed. Safety assessments included endometrial histology and thickness, and breast and gynecological examinations. Efficacy evaluations included changes from baseline to week 12 in percentage of superficial and parabasal cells and vaginal pH.</p></sec><sec><title>Results</title><p> Of 426 randomized subjects, 81.9% (<italic>n = </italic>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 months 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 (histopathology); however, only one (ospemifene) was confirmed as a true polyp during additional expert review. Endometrial histology 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.</p></sec><sec><title>Conclusions</title><p> The findings of this 52-week study confirm the tolerance and efficacy of oral ospemifene previously reported in short- and long-term studies.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Bachmann, Ga" uniqKey="Bachmann G">GA Bachmann</name></author><author><name sortKey="Nevadunsky, Ns" uniqKey="Nevadunsky N">NS Nevadunsky</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Santoro, N" uniqKey="Santoro N">N Santoro</name></author><author><name sortKey="Komi, J" uniqKey="Komi J">J Komi</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Pastore, Lm" uniqKey="Pastore L">LM Pastore</name></author><author><name sortKey="Carter, Ra" 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R." last="Goldstein">S. R. Goldstein</name><name sortKey="Lin, V H" sort="Lin, V H" uniqKey="Lin V" first="V. H." last="Lin">V. H. Lin</name></noCountry><country name="États-Unis"><noRegion><name sortKey="Bachmann, G A" sort="Bachmann, G A" uniqKey="Bachmann G" first="G. A." last="Bachmann">G. A. Bachmann</name></noRegion><name sortKey="Portman, D J" sort="Portman, D J" uniqKey="Portman D" first="D. J." last="Portman">D. J. Portman</name></country><country name="Italie"><noRegion><name sortKey="Koninckx, P R" sort="Koninckx, P R" uniqKey="Koninckx P" first="P. R." last="Koninckx">P. R. Koninckx</name></noRegion></country><country name="Finlande"><noRegion><name sortKey="Ylikorkala, O" sort="Ylikorkala, O" uniqKey="Ylikorkala O" first="O." last="Ylikorkala">O. Ylikorkala</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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