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Ospemifene in the Management of Vulvar and Vaginal Atrophy: Focus on the Assessment of Patient Acceptability and Ease of Use

Authors Cagnacci A, Xholli A, Venier M

Received 1 October 2019

Accepted for publication 28 December 2019

Published 10 January 2020 Volume 2020:14 Pages 55—62


Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 2

Editor who approved publication: Dr Johnny Chen

Angelo Cagnacci, 1 Anjeza Xholli, 2 Martina Venier 2

1Obstetrics and Gynaecology Unit, Obstetrics and Gynaecology University of Genova, Genova, Italy; 2Obstetrics and Gynaecology Unit, Azienda Sanitaria Universitaria Integrata di Udine, Udine, Italy

Correspondence: Angelo Cagnacci
Ginecologia e Ostetricia, Policlinico San Martino, Via Largo Benzi 10, Genova 16132, Italy

Abstract: Endocrinological changes that occur with menopause lead to a chronic and progressive condition named vulvar and vaginal atrophy (VVA). This disease is characterized by symptoms such as dryness, dyspareunia, itching, burning, and dysuria. According to recent epidemiological studies, VVA has a high prevalence and can also occur in younger women prior to the menopause, negatively affecting quality of life, sexual function, intimacy and relationship with the partner. Accordingly, therapy should be effective, initiated early and continued for as long as possible. Up to recent years, available therapeutic options have included over-the-counter lubricants and moisturizers, vaginal oestrogens and systemic hormones. These products are not indicated for all women. Hormones are mostly contraindicated in women with a history of hormone-sensitive cancer and are frequently not accepted even by women without contraindications. Local therapies are frequently considered uncomfortable, difficult to apply, and messy. Indeed, these treatments have a high spontaneous discontinuation rate, mostly due to dissatisfaction, safety concern, side effects and difficulty in vaginal placement. Recently, ospemifene, a new non-hormonal systemic remedy, was approved by FDA (Food and Drug Administration) and EMA (European Medicines Agency) for the treatment of the two most bothersome symptoms of VVA: dryness and dyspareunia. Because ospemifene is a selective estrogen receptor modulator (SERM), it can be administered also in women with a history of breast cancer, and this makes it more acceptable by any woman. In addition, its route of administration minimizes those bothersome side effects intrinsic to the vaginal route of administration. Available data indicate that women using ospemifene have higher adherence to treatment, higher persistence and lower discontinuation rate. Satisfaction is higher than with other local therapies and overall health care cost is lower.

Keywords: ospemifene, vaginal estrogens, vulvar atrophy, vaginal atrophy, acceptability

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