Symptoms and General Pathology

All Conditions

Atrophy

Pathological Conditions, Anatomical

All Drugs and Chemicals

Aromatase Inhibitors

Vagivital

Aino Fianu Jonasson, MD, PhD

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.

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.

Evaluation of VagiVital® for Treatment of Vaginal Atrophy

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

Change from baseline to Week 12 in severity of VA symptom (vaginal irritation and itching, dyspareunia, vaginal dryness, dysuria or presence of vaginal bleeding associated with sexual activity) that has been self-identified by the subject as being the most bothersome to her.The VA Symptoms are graded from 0-3, where 0 = none and 3 = severe

Change from baseline to Week 4 in Vaginal pH

Change from baseline to Week 12 in Vaginal pH

Change from baseline to Week 4 in severity of the VA symptoms (vaginal irritation and itching, dyspareunia, vaginal dryness, dysuria or presence of vaginal bleeding associated with sexual activity). The VA Symptoms are graded from 0-3, where 0 = none and 3 = severe

Change from baseline to Week 12 in Quality of Life evaluation parameters Women's Health Questionnaire. Total Score (sum of the questions as recorded in the data management system (Yes, definitely=0, Yes, sometimes=1, No, not much=2 or No, not at all=3) except for question 7, 8, 10, 12 and 14 where the score opposite in points. Missing values are imputed using the mean of all recorded values. Analysis set ITT.

The adverse events will be classified as non-serious adverse event or serious adverse event (SAE), the intensity will be graded as mild, moderate or severe and causality will be classified as unlikely, possible and probably.

Change from baseline to Week 4 in blood pressure

Change from baseline to Week 12 in blood pressure

Change from baseline to Week 4 in heart rate

Change from baseline to Week 12 in heart rate

Change from baseline to Week 12 in the degree of vaginal atrophy. The assessment is made by okular gynocological examinations and graded mild, moderate and severe.

Number of urine infections during the study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of VagiVital® for Treatment of Vaginal Atrophy	NCT03998722	Vaginal Atrophy	Vagivital	18 Years -	PepTonic Medical AB
Evaluation of VagiVital® for Treatment of Vaginal Atrophy	NCT03998722	Vaginal Atrophy	Vagivital	18 Years -	PepTonic Medical AB
Evaluation of VagiVital® for Treatment of Vaginal Atrophy	NCT03998722	Vaginal Atrophy	Vagivital	18 Years -	PepTonic Medical AB

Spots Global Cancer Trial Database for vagivital

Every month we try and update this database with for vagivital cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for vagivital

Every month we try and update this database with for vagivital cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for vagivital cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.