This is a multicenter, randomized, double-blind, placebo-control phase III study to test the efficacy and safety of the drug. Patients are divided into two therapy groups.
The estimated duration of the enrollment will be 9 months. Patient participation will comprise 12 weeks, with more than 20 study sites engaged. Overall, more than 200 patients are to be randomized.
Female sexual dysfunction is a significant medical problem, which attracts increasing attention from the public as well as the medical community. Treatment of patients is conducted individually and is based on a variety of psychotherapeutic techniques, while pharmacological drugs are used only as a supporting therapy. At the same time, such treatment is long and expensive, and consequently not readily available. That is why this study is particularly relevant in today’s world.
The OCT team is responsible for site-management, monitoring, project management, regulatory and logistics activities, quality assurance and the production of a final clinical report.