OCT initiates a phase III clinical trial in patients suffering from mastalgia with fibrocystic breast changes. The trial will be placed at 8 sites in Russia. OCT is going to enrol up to 150 patients. The study is a preregistration trial in Russia. OCT will be responsible for feasibility, regulatory, study drug management, study management and monitoring. The drug we are going to study is a herbal drug which has very good pre-clinical and clinical data. Our client has conducted extensive studies on many herbs and plants with internationally acclaimed results.
Mastalgia affects up to two-thirds of women at some stage of their reproductive lives. Although it is usually benign, it can be associated with conditions of PMS, fibrocystic breast changes (FCC), and with some rare extramammary conditions, e.g. Tietze syndrome. Mastalgia has an age peak at 34 years. Most women with cyclic mastalgia describe their pain as “heavy” or “aching”, whereas in women with non-cyclic mastalgia, the pain severity is rather related to the size of the painful area, and affective components are more prominent. Therefore, cyclic and non-cyclic mastalgia show certain differences with substantial overlap. Mastalgia is considered as being in a causal connection with latent or slightly increased basal prolactin serum levels.
The objective of this clinical trial is to investigate the efficacy and safety of study drug in women suffering from mastalgia with fibrocystic breast changes. The already existing data, which indicate a positive benefit/risk-ratio of the study drug in the treatment of mastalgia should be strengthened.
OCT has good experience in women healthcare studies and we would be happy to share it with the client in this study. It is our second time we conduct clinical trials for this sponsor in Russia.