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Effect of a Lactic Acid and Glycogen Containing Vaginal Product in Relation to HPV Persistence in HPV-Positive Women A Randomized Controlled Trial

Effect of a Lactic Acid and Glycogen Containing Vaginal Product in Relation to HPV Persistence in HPV-Positive Women A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20251216004
Enrollment
126
Registered
2025-12-16
Start date
2025-12-29
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Women with positive HPV DNA testing at Maharat Nakorn Chiangmai hospital HPV, vaginal dysbiosis

Interventions

Apply 1 amplue (5 mg) vaginal supposity per day hs and 7 day per months Total 6 months,No treatment
Experimental Drug,No Intervention No treatment
Intravaginal lactic acid and glycogen containing gel products,Control

Sponsors

Faculty of medicine, Chiangmai University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
35 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Women aged 35 to 65 years 2.Patients who are being followed up due to previous abnormal results or newly referred patients whose HPV DNA test and cytology indicate HPV infection according to any of the following criteria 2.1. Positive for HPV types 16/18, regardless of cytology results and colposcopic direct biopsy shows no CIN2 or higher severity 2.2.Positive for non16/18 HPV types with abnormal cytology and colposcopic direct biopsy shows no CIN2 or higher severity 2.3. Positive for other HPV types (non-16/18) with normal cytology 3. Willing to refrain from using any intravaginal products (e.g., probiotics or vaginal cleansers) during the study. 4. Able to provide written informed consent and comply with study procedures.

Exclusion criteria

Exclusion criteria: 1.Pregnant women 2.Immunocompromised status or receiving immunosuppressive therapy 3.Colposcopic directed biopsy showing CIN2 or higher 4.History of hysterectomy 5.Allergy to any component of the study product

Design outcomes

Primary

MeasureTime frame
HPV test in 6 months 6 months Co-testing

Secondary

MeasureTime frame
Cytology 6 months Liquid based cytology,Vaginal pH 6 months Universal indicator pH paper

Countries

Thailand

Contacts

Public ContactPhitsinee Sabyeying

Faculty of Medicine, Chiang Mai University

phitsinee.s@cmu.ac.th0955353777

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026