Evaluation of VagiVital® for Treatment of Vaginal Atrophy

Status Completed

Clinical Trial 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.

Clinical Trial Description

Management of breast cancer involves systematic therapies including chemotherapy and endocrine therapy which can lead to vaginal atrophy (VA), caused by decreased levels of circulating estrogen to urinary and vaginal receptors. Due to the reduced estrogen production, less vaginal fluid is produced within the vagina and the mucosa becomes thinner and more fragile. This group of patients can not use estrogen treatment to reduce the symptoms of vaginal atrophy. A previous study showed a significant reduction in the severity of the most bothersome VA symptoms and vaginal pH was improved (decreased) as well as increased percentage of superficial cells over a 12 week treatment period with Vagivital. In this study all participants will self- administer the intravaginal gel once daily for 12 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03998722
Study type	Interventional
Source	PepTonic Medical AB
Contact
Status	Completed
Phase	N/A
Start date	June 14, 2019
Completion date	June 24, 2020

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