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Lactobacillus Vaginalis Capsules for the Management of Vulvovaginal Atrophy in Young Breast Cancer Patients - Trial NCT05974449

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.

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NCT05974449
Phase 2
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05974449
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Lactobacillus Vaginalis Capsules for the Management of Vulvovaginal Atrophy in Young Breast Cancer Patients
Phase II Clinical Study of Lactobacillus Vaginalis Capsules for the Management of Vulvovaginal Atrophy During Ovarian Protection in Young Breast Cancer Patients

Study Focus

Breast Cancer Female

Vaginal Lactobacillus capsules

Interventional

drug

Sponsor & Location

The First Affiliated Hospital with Nanjing Medical University

Timeline & Enrollment

Phase 2

Aug 01, 2023

Dec 30, 2024

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, unspecified
Malignant neoplasm of breast
Malignant neoplasm of breast
Carcinoma in situ of breast, unspecified
Personal history of malignant neoplasm of breast

Data Source

ClinicalTrials.gov

NCT05974449

Non-Device Trial