NCT01987804

Dose-relationship of Vaginally Administrated Oxytocin in Postmenopausal Women

A Double-blind, Placebo Controlled Single Centre Trial to Evaluate the Dose-relationship of the Effects of Vaginally Administered Oxytocin on the Vaginal Mucosal Membrane in Postmenopausal Women With Vaginal Atrophy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: PepTonic Medical AB · Industry
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

Up to 50% of all postmenopausal women, experience vaginal drynes, i.e. vaginal atrophy is a consequence due to the lack of estrogen. In addition, vaginal atrophy is associated with an increased pH, which creates an environment more susceptible to infections . The mucosal epithelium shows signs of severe senile atrophy and cytological examination demonstrate increased number of the basal and parabasal cells and reduced number of superficial cells . Unlike some other menopausal symptoms (for instance hot flushes), vaginal symptoms generally persist or worsen with aging.Oxytocin is a peptide hormone and it is released systemically via the posterior pituitary. The most well known effects of oxytocin are its roles in female reproduction such as facilitation of birth and breast feeding. Oxytocin has also shown to exert positive effects on the proliferation of human vaginal mucosal cells from postmenopausal women, an effect which could be attributed either to the direct stimulation of new cell formation or to an increased production of other growth factors. The primary objective is to investigate the dose relationsship of topical administrated Vagitocin on the vaginal mucosal membrane, measured in the change (%)of superficial cells up to 7 weeks after baseline.

Conditions

• Vaginal Atrophy

Interventions

Type	Name	Description
DRUG	Oxytocin 100 i.u.
DRUG	Oxytocin 400 i.u.
DRUG	Placebo

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-12-01
• Completion: 2013-01-01
• First posted: 2013-11-19
• Last updated: 2020-11-13

Locations

1 site across 1 country: Sweden