Efficacy of ospemifene on female sexual function in patients with vulvovaginal atrophy and breast cancer history: a randomized, double-blind, controlled clinical trial

Abstract

Background: Vulvovaginal atrophy (VVA) is a condition affecting about 50% of postmenopausal women with a negative repercussion on their sexual function and quality of life when its symptoms are moderate to severe. When first line treatments consisting in moisturizers and lubricants aren’t enough, local oestrogenic therapy (LET) is recommended for the general population. For women with breast cancer history suffering from moderate to severe VVA, there is concern about LET safety as it is a hormonal treatment and so, its recommendation is controverted. Thus, in the daily clinical practise these patients, apart from moisturizers and lubricants, any other treatment option is nowadays offered. Ospemifene is a SERM presented as a new treatment option for these group of patients as preclinical and clinical trials have shown efficacy on improving VVA while it appears to be endometrial and breast safe. Objectives: The main objective of the trial is to assess the improvement of female sexual function in patients with moderate – severe vulvovaginal atrophy and history of breast cancer treated with ospemifene versus placebo. Also, to assess VVA parameters and collect safety data. Design and method: It is a randomized, double-blind, multicentric trial involving 560 women with moderate to severe VVA and history of breast cancer. They will be recruited using a consecutive non – probabilistic sampling for 2 years. Patients will be randomized 1:1 for treatment with ospemifene or placebo for 12 weeks. Follow – up will be carried out during the treatment and post treatment period to assess mainly their sexual function and other variables about quality of life, VVA and safety data