NCT04629885

Study to Evaluate Efficacy of Vagitocin in Postmenopausal Women With Vulvovaginal Atrophy Symptoms

A Phase 2b, Double-blind, Randomized, Parallel, Placebo-Controlled Study to Evaluate the 12-week Efficacy of Vagitocin in Postmenopausal Women With Symptoms of Vulvovaginal Atrophy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: PepTonic Medical AB · Industry
• Sex: Female
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A randomized, double-blind, placebo controlled Phase 2b study, divided in 2 parts: * The main part of the study investigates the efficacy and safety of the Investigational Medicinal Product (IMP), intravaginally administered in glass syringes, on postmenopausal women with vulvovaginal atrophy symptoms. * The exploratory part of the study investigates the efficacy and safety of the IMP, intravaginally administered in a laminate tube, on postmenopausal women with vulvovaginal atrophy symptoms. A comparison of plasma levels of oxytocin when the IMP is administered by 2 different applicators will be investigated in a sub-group of patients. In the main part, 160 subjects are enrolled and randomized to 2 different groups; 80 subjects receiving IMP and 80 subjects receiving placebo, in glass syringes. In the exploratory part of the study, 40 patients will be enrolled and randomized to 2 different groups; 30 subjects receiving IMP and 10 patients receiving placebo, in laminate tubes. The study is conducted at 3 sites in Sweden, and comprises 5 visits: screening visit (Visit 0), randomization visit (Visit 1; Day 0), treatment follow-up visit (Visit 2; Week 4), end of treatment visit (Visit 3; Week 12) and a telephone follow-up visit (Visit 4; Week 14). All patients self-administer the IMP once daily for 12 weeks.

Conditions

• Vulvovaginal Atrophy

Interventions

Type	Name	Description
DRUG	Oxytocin 400 IU vaginal gel
DRUG	Placebo	Matching placebo gel with identical appearance to the test product, used as reference treatment.

Timeline

• Start date: 2016-05-03
• Primary completion: 2017-05-03
• Completion: 2017-05-03
• First posted: 2020-11-16
• Last updated: 2020-11-16

Locations

3 sites across 1 country: Sweden