Clinical trial · Interventional
Efficacy of 851B Gel for Treating High-Risk Cervical Human Papillomavirus Infection in Women.
A Randomized, Double-blind, Placebo-Controlled, Dose Response Study to Evaluate 851B Gel Delivered Intravaginally Twice a Week for Two, Three-Week Cycles in Women Who Are Positive For High-Risk Genotypes of Human Papillomavirus and Have Mild Cytological Abnormalities
NCT00117884CI-TRIAL-00023571terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of efficacy
Summary
Brief summary (as posted)
The purpose of this study was to evaluate efficacy of 851B gel over a range of concentrations and dosing regimens on high-risk cervical human papillomavirus infection in women.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Papillomavirus Infections | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 851B | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (11)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: 851B
- type
- EXPERIMENTAL
- label
- 2
- interventionNames
- Drug: 851B
- type
- EXPERIMENTAL
- label
- 3
- interventionNames
- Drug: 851B
- type
- EXPERIMENTAL
- label
- 4
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Willing to be on acceptable method of birth control * Have a Pap smear result of LSIL or ASCUS * Is high risk HPV positive Exclusion Criteria: * No evidence of high-grade disease or glandular abnormalities, * Complete visualization of all lesion margins and the transformation zone, * No uncontrolled significant medical illness or sexually transmitted infections, * Taking any restricted medications such as interferon, immunomodulators, cytotoxic drugs, investigational drugs, steroids.
References
Publications (0)
Data not yet available
No reference posted for this study.