The phase 2b study is a double-blind, placebo-controlled, multicenter study and comprise two arms of 80 patients each, in total 160 patients. The objective of the study is to investigate the effect of Vagitocin® (400 IU/day) compared to placebo for the treatment of vaginal atrophy. The Vagitocin® gel will be stored in glass syringes and refrigerated during the study. In an exploratory part of the study, comprising 40 study subjects, the Vagitocin® gel will be stored in a laminate tube and refrigerated.
”We are pleased to note that we are keeping to the time table of the study. This shows that the set routines and logistics are working – starting from the manufacturing of the study materials to the initiation of the clinics”, says Johan Inborr, CEO of Peptonic Medical. “All study sites have started patient screening and medical treatments according to plan, and patient in-flow is very good. During July - the main summer vacation month - recruitment of study subjects will slow down.”
Results from the study are expected by the end of 2016.
For more information, please contact;
Johan Inborr, CEO
Telephone: +46 708 853 893
About Peptonic Medical AB
Peptonic Medical AB (publ) is an innovative Swedish pharmaceutical company developing oxytocin based products e.g. for the treatment of menopausal symptoms, such as vaginal atrophy. Peptonic Medical’s mission is to develop safe and effective drugs based on the well-known beneficial properties of oxytocin.