Study to Evaluate Efficacy of Vagitocin in Postmenopausal Women With Vulvovaginal Atrophy Symptoms
Status:
Completed
Trial end date:
2017-05-03
Target enrollment:
Participant gender:
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.