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

NCT04629885 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2020-11-16

No results posted yet for this study

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

DRUG

Oxytocin 400 IU vaginal gel

DRUG

Placebo

Matching placebo gel with identical appearance to the test product, used as reference treatment.

Sponsors & Collaborators

  • PepTonic Medical AB

    lead INDUSTRY

Principal Investigators

  • Aino Fianu Jonasson, MD · Kvinnoforskningsenheten K59, Karolinska Universitetssjukhuset, Huddinge

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-03
Primary Completion
2017-05-03
Completion
2017-05-03

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04629885 on ClinicalTrials.gov