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NCT05974449
Lactobacillus Vaginalis Capsules for Treatment of Vulvovaginal Atrophy in Young Breast Cancer Patients
Phase 2 trial testing Vaginal Lactobacillus capsules in Breast Cancer Female in 60 participants. Currently enrolling.
31 December 2025
Quick facts
| Lead sponsor | The First Affiliated Hospital with Nanjing Medical University |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 60 |
| Start date | 24 August 2023 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Vaginal Lactobacillus capsules — full drug profile →
Conditions studied
- Breast Cancer Female — all drugs for Breast Cancer Female →
Sponsor
The First Affiliated Hospital with Nanjing Medical University
Who can join
Adults 18 to 45, female only, with Breast Cancer Female. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Intestinal flora: a potential pathogenesis mechanism and treatment strategy for type 1 diabetes mellitus.
Huang S, Li F, Quan C, Jin D. · · 2024 · cited 8× · PMID 39520706 · DOI 10.1080/19490976.2024.2423024
Verify or expand the search:
- PubMed search for NCT05974449
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05974449 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The First Affiliated Hospital with Nanjing Medical University
- Last refreshed: 12 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05974449.
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