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

NCT05974449 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-12-12

No results posted yet for this study

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.

Conditions

  • Breast Cancer Female

Interventions

DRUG

Vaginal Lactobacillus capsules

This product is a micro-ecological preparation made from live Lactobacillus and is used for the treatment of vaginosis caused by disorders of the flora.

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Principal Investigators

  • Jue Wang, MD · The First Affiliated Hospital with Nanjing Medical University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-24
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05974449 on ClinicalTrials.gov