MedTrace Logo

Evaluation of VagiVital® for Treatment of Vaginal Atrophy

NCT03998722 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2020-11-13

No results posted yet for this study

Summary

An open study to evaluate the ability of VagiVital in reducing the severity of moderate to severe symptoms of vaginal atrophy for women under treatment on adjuvant aromatase inhibitor therapy. Vaginal pH and a self-assessment of the symptoms will be assessed. The treatment consists of administration of intravaginal gel from an applicator filled from a tube, once daily for 12 weeks. All participants will self- administer the intravaginal gel once daily for 12 weeks.

Conditions

  • Vaginal Atrophy

Interventions

DEVICE

Vagivital

Vagivital once Daily for 12 weeks

Sponsors & Collaborators

  • PepTonic Medical AB

    lead INDUSTRY

Principal Investigators

  • Aino Fianu Jonasson, MD, PhD · Karolinska Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-14
Primary Completion
2020-06-10
Completion
2020-06-24

Countries

  • Sweden

Study Locations

More Related Trials

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 NCT03998722 on ClinicalTrials.gov