Evaluation of VagiVital® for Treatment of Vaginal Atrophy

NCT03998722 | Completed

• 1 other identifier: Vagipep101
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginal Atrophy

Outcome Measures

Primary Outcomes (1)

• Change in severity of VA symptom

  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

  12 weeks

Secondary Outcomes (11)

• Change in Vaginal pH

  4 weeks

• Change in Vaginal pH

  12 weeks

• Change in severity of VA Symptom

  4 weeks

• Change in total score in Quality of Life evaluation parameters

  12 weeks

• Number of AEs and assessment of intensity, causality and seriousness of Advers Events

  14 weeks

Study Arms (1)

Vagivital

EXPERIMENTAL

Vagivital once Daily for 12 weeks

Device: Vagivital

Interventions

Vagivital DEVICE

Vagivital once Daily for 12 weeks

Vagivital

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To participate in the investigation, a subject must:
• Be a female, 18 years or older, who is willing to participate in the study as indicated by signing the informed consent.
• Women over the age of 18 who have been diagnosed with cancer and are currently taking adjuvant AI therapy who also complain of vaginal atrophy symptoms including vaginal dryness, vaginal itching, frequent urinary tract infections, or dyspareunia are candidates for this study. They also have to be sexually active or wanted to be so, but couldn´t because of problems with vaginal atrophy.
• Have one moderate to severe VA symptom (vaginal irritation and itching, vaginal dryness, dysuria, dyspareunia or presence of vaginal bleeding associated with sexual activity) that has been identified by the subject as being the most bothersome to her according to the scale presented in APPENDIX B.
• Be judged by the Principal Investigator as being in otherwise good health based on the medical evaluation performed at baseline. The medical evaluation findings must include:
• A normal or clinically non-significant finding at physical examination, including vital signs (blood pressure and heart rate).
• A normal or clinically non-significant finding at gynecological examination.
• A normal or clinically non-significant finding at clinical breast examination. An acceptable breast examination is defined as an examination in which no masses or other findings are identified which are suspected of being malignant.
• Urine analysis test results within reference limits or with non-significant deviations from reference values.
• Be willing to abstain from sexual activity and the use of vaginal douching within 24 hours prior to vaginal pH measurements at screening and at Visits 2 and 3.

You may not qualify if:

• To participate in the investigation, a subject must not:
• Be currently hospitalized.
• Have a history of ongoing cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychological, or musculoskeletal disease or disorder that is clinically significant in the opinion of the Principal Investigator or Sub-Investigator.
• Have a history of undiagnosed vaginal bleeding.
• Have an ongoing urogenital infection at the screening visit.
• Any contraindication to the gel (VagiVital) therapy and allergy to the use of any components of the investigational device.
• Have a history of drug and/or alcohol abuse within one year of start of study.
• Have used any prescription or OTC medications including phytoestrogens, herbal medicinal products or hormonal intra-uterine device with known estrogenic effects within 12 weeks prior to screening procedures.
• Have used any type of vaginal lubricants and moisturizers within 24 hours prior to screening procedures.
• Have used estrogen alone or estrogen/progestin for any of the following time periods:
• Vaginal hormonal products (rings, creams, gels, vaginal suppositories) within 12 weeks prior to Screening procedures;
• Transdermal estrogen alone or estrogen/progestin products including percutaneous estrogen gels for at least 12 weeks prior to screening procedures.
• Oral estrogen and/or progestin therapy within 12 weeks prior to Screening procedures;
• Intrauterine progestin therapy within 12 weeks prior to Screening procedures;
• Progestin implants and estrogen alone injectable drug therapy within 12 weeks prior to screening procedures;

Sponsors & Collaborators

• PepTonic Medical AB: lead

Study Sites (1)

Karolinska University Hospital

Stockholm, 141 86, Sweden

Location

Study Officials

• Aino Fianu Jonasson, MD, PhD

  Karolinska Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: An open single-armed study

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: June 26, 2019
• Study Start: June 14, 2019
• Primary Completion: June 10, 2020
• Study Completion: June 24, 2020
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)