PEPTONIC medical (publ) today announced it has engaged five study sites, all of them in Sweden, to participate in the next Phase 2b study and appointed A+ Science AB as the CRO to coordinate and monitor the study with PEPTONIC’s developmental estrogen-free product Vagitocin® in post-menopausal women. The enrollment of the first patient is due to start according to plan in October this year.
The Phase 2b study is a double-blind, placebo-controlled multicenter study and comprise three arms of 80 patients each, that is 240 patients in total. The objective of the study is to investigate the effect of two doses of oxytocin (200 IU or 400 IU) against placebo in women suffering from vaginal atrophy.
“We are pleased to have secured five centers with experienced leaders and staff to guarantee high quality data collection and patient monitoring”, said Dan Markusson, CEO of PEPTONIC medical, “and we look forward to working with A+ Science, which has a long and impressive track record of clinical study management”.
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.
For more information, please contact:
Dan Markusson, CEO
+46 768 550 200
About vaginal atrophy
In conjunction with menopause, many women develop vaginal atrophy. It is the decreasing estrogen levels occurring during menopause that results in vaginal atrophy, as estrogen stimulates the growth of the mucosa. Symptoms such as vaginal dryness, irritation and itching are common in women with vaginal atrophy. The risk of developing infection is increased and sexual intercourse can be painful which affects sex life negatively.
Frequently these problems can be improved by means of estrogen treatment in the form of tablets, patches or local treatment with creams or vaginal inserts. However, not all women can or are willing to use estrogen. PEPTONIC’s Vagitocin ®, which contains oxytocin, offers an alternative to estrogen.
Vagitocin® is a pharmaceutical preparation for the treatment of vaginal atrophy. The product is based on oxytocin, a natural substance, which is produced in the body and which has been used to promote labour and breast-feeding since the beginning of the 1960ies. Local application of Vagitocin® in the vagina has been shown to rejuvenate the vaginal mucosa.
Oxytocin is a peptide hormone that is produced in the brain. It is well known for its hormonal actions in conjunction with birth and breast feeding, as it stimulates contractions of the womb during the labour and helps eject the milk during breast-feeding. It has been used clinically since the 1960’ies and is applied as injections, drip or nasal spray.
Oxytocin is the active ingredient of Vagitocin®. The oxytocin gel is administered in the vagina to exert local healing effects on the vaginal mucosa. Oxytocin has a long history of safe and effective medical use and offers an alternative to estrogen and estrogen-like acting compounds for menopausal and postmenopausal women.