Peptonic Medical’s applications for starting a phase 2b clinical study have been approved by the Swedish Medical Products Agency and the Central Ethical Review Board.
According to the company, the aim of the study is to investigate the effect of Peptonic Medical’s product candidate Vagitocin in menopausal and post-menopausal women suffering from vaginal atrophy.
“We are pleased to have obtained the approvals from both the Medical Products Agency and the Central Ethical Review Board to initiate the study”, said Dan Markusson, CEO of Peptonic Medical. “This is in line with our time plan, and we can now continue with the preparations and start the study without delay.”
The Phase 2b study is a double-blind, placebo-controlled multicenter study and comprises three arms of 80 patients each, and 240 patients in total. The objective of the study is to investigate the effect of two doses of Vagitocin (200 IU or 400 IU/day) against placebo in the treatment of vaginal atrophy.
Peptonic Medical states that 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, will be the principal investigator of this clinical study. The first patients are expected to be recruited to the study in October this year.