Saginil in vs. Placebo for Gynecologic Oncology Patients Affected by Vaginitis
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ClinicalTrials.gov Identifier: NCT01420510 |
Recruitment Status : Unknown
Verified June 2013 by Fabio Ghezzi, Università degli Studi dell'Insubria.
Recruitment status was: Recruiting
First Posted : August 19, 2011
Last Update Posted : June 21, 2013
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Condition or disease | Intervention/treatment | Phase |
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Vaginitis | Drug: Adelmidrol vaginal gel Drug: Placebo vaginal gel | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Saginil in Vaginal Cannulas vs. Placebo for the Prevention of Vaginitis in Gynecologic Oncologic Patients Receiving Chemotherapy: a Randomized Controlled Trial. |
Study Start Date : | September 2011 |
Estimated Primary Completion Date : | November 2014 |
Estimated Study Completion Date : | December 2014 |
Arm | Intervention/treatment |
---|---|
Experimental: Adelmidrol
Efficacy of Adelmidrol vaginal gel in preventing vaginitis in oncologic patients
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Drug: Adelmidrol vaginal gel
Application of a Adelmidrol vaginal gel |
Placebo Comparator: Placebo
Efficacy of Placebo in preventing vaginitis in oncologic patients
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Drug: Placebo vaginal gel
Application of a placebo vaginal gel |
- Number of patients with vaginitis in the group taking Adelmidrol (vaginal cannulas) vs. number of patients with vaginitis in the Placebo group [ Time Frame: 2 months ]

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Gynecologic malignancy
- Current administration of chemotherapy
Exclusion Criteria:
- Colpectomy
- Vaginal cancer
- Vulvar cancer
- Bacterial vaginitis

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01420510
Contact: Fabio Ghezzi, MD | +390332299309 | fabio.ghezzi@uninsubria.it |
Italy | |
Gynecologic Oncology Unit | Recruiting |
Varese, Italy, 21100 | |
Contact: Fabio Ghezzi, MD +390332299309 fabio.ghezzi@uninsubria.it | |
Principal Investigator: Fabio Ghezzi, MD |
Responsible Party: | Fabio Ghezzi, Professor, Università degli Studi dell'Insubria |
ClinicalTrials.gov Identifier: | NCT01420510 |
Other Study ID Numbers: |
Saginil in vaginitis |
First Posted: | August 19, 2011 Key Record Dates |
Last Update Posted: | June 21, 2013 |
Last Verified: | June 2013 |
Patients satisfaction Side effects |
Vaginitis Vaginal Diseases |