About 150 women aged 21 and over are expected to be screened, of which more than 100 are expected to be randomized. Patients will be divided in 2 therapeutic groups in a 1:1 ratio. The study will last for approximately one year with a 6-month enrollment phase.
Female sexual dysfunction is one of the causes of problems associated with the central regulation of reproductive function. There are currently no approved pharmacological treatments for female sexual dysfunction. The treatment for this condition is based on various psychotherapeutic techniques thus making drug therapy options auxiliary, if used at all. The study product is developed to treat idiopathic female infertility which is presumably etiologically associated with factors of central origin, including psychogenic factors. According to the results of a phase I open-label clinical trial, the study product has been shown to improve sexual function in female subjects.
At the moment, over 50 patients are already randomized.