Study on the Impact and Safety of Vaginal Lactobacillus Viable Capsules on the Clearance Rate of High-Risk HPV Infection in Postmenopausal Women

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500114563

Enrollment

Unknown

Registered

2025-12-15

Start date

2026-01-01

Completion date

Unknown

Last updated

2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

high-risk HPV infection in postmenopausal women

Interventions

Control Group:None

Combination Therapy Group:Vaginal Lactobacillus Viable Capsule (Ding Jun Sheng) combined with Recombinant Human Interferon a2b Vaginal Effervescent Capsule (Xin Fu Ning)

Observation Group:Vaginal Lactobacillus viable capsule monotherapy

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Female patients who have been postmenopausal for more than 1 year; 2. Confirmed HR-HPV infection (16/18/31/33/35/39/45/51/52/56/58/59/68) by HPV DNA/mRNA testing; 3. TCT (cytology results of NILM, ASCUS, or LSIL); 4. No cervical lesions on biopsy within the past 6 months; 5. No use of antiviral drugs or immunomodulators for HPV infection within the past 3 months; 6. Commitment to abstain from unprotected sexual activity during the treatment period; 7. Willingness to sign the informed consent form and complete follow-up.

Exclusion criteria

Exclusion criteria: 1. Individuals who have undergone or plan to undergo laser therapy, LEEP procedure, or radical surgery; 2. Patients currently receiving hormone replacement therapy; 3. Those with other serious internal diseases, such as severe heart, liver, or kidney dysfunction; 4. Individuals with serious immunodeficiency diseases; 5. Patients with any tumor diseases (including cervical cancer); 6. Individuals with severe allergic reactions to drugs or capsule shells; 7. Those who have participated in other drug clinical trials in the past 3 months; 8. Individuals deemed unsuitable by the investigator to participate in this study.

Design outcomes

Primary

Measure	Time frame
Clearance rate of HR-HPV at month 6;	—

Secondary

Measure	Time frame
Vaginal environment (Lactobacillus grading, cleanliness, pH value, H2O2);Vulvar and vaginal symptom score;Vaginal Health Index Score;	—

Countries

China

Contacts

Public ContactYunfeng Fu

Women’s Hospital, Zhejiang University School of Medicine

5100008@zju.edu.cn+86 571 87061501

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026