NCT05974449

Lactobacillus Vaginalis Capsules for the Management of Vulvovaginal Atrophy in Young Breast Cancer Patients

Name: Clinical Trial NCT05974449
Creator: The First Affiliated Hospital with Nanjing Medical University
Keywords: Breast Cancer Female, Vaginal Lactobacillus capsules, Phase 2, drug, clinical trial

Phase II Clinical Study of Lactobacillus Vaginalis Capsules for the Management of Vulvovaginal Atrophy During Ovarian Protection in Young Breast Cancer Patients

The First Affiliated Hospital with Nanjing Medical University·Phase 2·ClinicalTrials.gov·drugNot yet recruiting

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Study focus

Disease/Condition: Breast Cancer Female
Drug/Device/Intervention: Vaginal Lactobacillus capsules
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: The First Affiliated Hospital with Nanjing Medical University

Timeline & enrollment

Phase: Phase 2
Start date: Aug 01, 2023
End date: Dec 30, 2024
Enrollment: 100 participants

Primary outcome

Vaginal PH,Functional Assessment of Breast Cancer Therapy Scale (FACT-B),Functional Assessment of Endocrine Therapy Scale (FACT-ES)

Summary

This study is a prospective, randomized controlled, phase II clinical study with a planned enrolment of 60 patients. The study focuses on the efficacy and safety of Lactobacillus vaginalis capsules for the prevention and/or treatment of vulvovaginal symptoms in young breast cancer patients receiving ovarian protection during chemotherapy, in order to improve compliance and quality of life in breast cancer patients.

ICD-10 classifications

Malignant neoplasm: Breast, unspecifiedMalignant neoplasm of breastMalignant neoplasm of breastCarcinoma in situ of breast, unspecifiedPersonal history of malignant neoplasm of breast

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT05974449
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT05974449 through Pure Global AI's free database. This Phase 2 trial is sponsored by The First Affiliated Hospital with Nanjing Medical University and is currently Not yet recruiting. The study focuses on Breast Cancer Female. Target enrollment is 100 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.