Clinical trial · Interventional
Saginil in vs. Placebo for Gynecologic Oncology Patients Affected by Vaginitis
Saginil in Vaginal Cannulas vs. Placebo for the Prevention of Vaginitis in Gynecologic Oncologic Patients Receiving Chemotherapy: a Randomized Controlled Trial.
NCT01420510CI-TRIAL-00010918unknownPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
We hypothesise that the use of Adelmidrol (Saginil in vaginal cannulas) can reduce the incidence and magnitude of vaginitis in patients affected by gynecologic malignancies.
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 |
|---|---|---|---|
| Vaginitis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adelmidrol vaginal gel | Drug | — | UNRESOLVED |
| Placebo vaginal gel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Adelmidrol
- description
- Efficacy of Adelmidrol vaginal gel in preventing vaginitis in oncologic patients
- interventionNames
- Drug: Adelmidrol vaginal gel
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Efficacy of Placebo in preventing vaginitis in oncologic patients
- interventionNames
- Drug: Placebo vaginal gel
Primary outcomes (1)
- measure
- Number of patients with vaginitis in the group taking Adelmidrol (vaginal cannulas) vs. number of patients with vaginitis in the Placebo group
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Gynecologic malignancy * Current administration of chemotherapy Exclusion Criteria: * Colpectomy * Vaginal cancer * Vulvar cancer * Bacterial vaginitis
References
Publications (0)
Data not yet available
No reference posted for this study.