Spots Global Cancer Trial Database for Evaluation of VagiVital® for Treatment of Vaginal Atrophy

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Trial Identification

Brief Title: Evaluation of VagiVital® for Treatment of Vaginal Atrophy

Official Title: An Open Single-arm Investigation to Evaluate the Use of VagiVital® for Treatment of Vaginal Atrophy in Cancer Patients Undergoing Adjuvant Aromatase Inhibitor Therapy - 12 Weeks Follow-up

Study ID: NCT03998722

Conditions

Vaginal Atrophy

Interventions

Vagivital

Study Description

Brief 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.

Detailed 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.