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.

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01420510

Enrollment

Registered

2011-08-19

Start date

2011-09-30

Completion date

2014-12-31

Last updated

2013-06-21

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

Conditions

Vaginitis

Keywords

Patients satisfaction, Side effects

Brief summary

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.

Interventions

DRUGAdelmidrol vaginal gel

Application of a Adelmidrol vaginal gel

DRUGPlacebo vaginal gel

Application of a placebo vaginal gel

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Inclusion criteria

* Gynecologic malignancy * Current administration of chemotherapy

Exclusion criteria

* Colpectomy * Vaginal cancer * Vulvar cancer * Bacterial vaginitis

Design outcomes

Primary

Measure	Time frame
Number of patients with vaginitis in the group taking Adelmidrol (vaginal cannulas) vs. number of patients with vaginitis in the Placebo group	2 months

Countries

Italy

Contacts

Primary ContactFabio Ghezzi, MD

fabio.ghezzi@uninsubria.it+390332299309

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026