Last subject exits Peptonic Medical’s phase 2b VVA study
Stockholm, 17 July 2015. Peptonic Medical AB (publ) - a company developing pharmaceuticals based on oxytocin - today announced that all of the randomized study subjects now have completed the study, which started in September 2014. In this study, the effect of treating menopausal and post-menopausal women suffering from vulvar and vaginal atrophy (VVA) with Peptonic Medcial’s oxytocin gel (Vagitocin®) is being investigated.
In total, 227 subjects were randomized in to the study. Of these, more than 95 per cent have completed the 12-week daily treatment and attended all of the follow-up visits during the course of the study. This is a very satisfactory outcome and provides a good basis for assessing the effects of the medical treatment with oxytocin. Overall, the study has progressed well in accordance with the plan and there are no major deviations or treatment related serious adverse effects to report.
The information collected during the study will now be analysed according to the study protocol and initial results are expected by mid September.
“It’s going to be very exciting to see the results of this study. I want to extend my gratitude to all those that have been engaged and contributed to the success so far – not least all the study subjects”, says Johan Inborr, CEO of Peptonic Medical, “We now go forward with the planning of the phase 3 programme”.
_____
For more information, please contact;
Johan Inborr, CEO
Telephone: +46 708 853 893
E-mail: johan.inborr@peptonicmedical.se
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.
About Peptonic Medical’s phase 2b study
The Phase 2b study is a double-blind, placebo-controlled, multicenter study and comprises three arms of 227 randomized patients in total. The objective of the study is to investigate the effect of two doses of Vagitocin® (200 IU or 400 IU/day) compared to placebo for the treatment of vaginal atrophy.
Five clinical centres in Sweden are participating in the clinical study. Associate professor Aino Fianu Jonasson, at the Department of obstetrics and gynecology at the Karolinska University hospital in Huddinge, is the principal investigator of this clinical study.