VaginitisPhase 2/3NCT01420510
Saginil in vs. Placebo for Gynecologic Oncology Patients Affected by Vaginitis
A Phase 2/3 study testing Adelmidrol vaginal gel in people with Vaginitis, run by Università degli Studi dell'Insubria at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Vaginitis
- What is being tested?
- Adelmidrol vaginal gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2011to Dec 2014
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Gynecologic malignancy
- Current administration of chemotherapy
Who cannot join
- Colpectomy
- Vaginal cancer
- Vulvar cancer
- Bacterial vaginitis
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Gynecologic Oncology Unit
Varese, 21100
Fabio Ghezzi, MD, +390332299309, fabio.ghezzi@uninsubria.it
Fabio Ghezzi, MD
About this study
Official title: Saginil in Vaginal Cannulas vs. Placebo for the Prevention of Vaginitis in Gynecologic Oncologic Patients Receiving Chemotherapy: a Randomized Controlled Trial.
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
- Vaginitis
- Being tested
- Adelmidrol vaginal gel, Placebo vaginal gel
- Keywords
- Patients satisfaction, Side effects
- Medical subject headings
- Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adelmidrol vaginal gelDrug
Application of a Adelmidrol vaginal gel
Placebo vaginal gelDrug
Application of a placebo vaginal gel
| Study group | Role | What they receive |
|---|---|---|
| Adelmidrol | Experimental | Efficacy of Adelmidrol vaginal gel in preventing vaginitis in oncologic patients Receives: Drug: Adelmidrol vaginal gel |
| Placebo | Placebo comparator | Efficacy of Placebo in preventing vaginitis in oncologic patients Receives: Drug: Placebo vaginal gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with vaginitis in the group taking Adelmidrol (vaginal cannulas) vs. number of patients with vaginitis in the Placebo group
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionNov 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaginitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Insubria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabio Ghezzi, Università degli Studi dell'Insubria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01420510
- Sponsor's protocol ID
- Saginil in vaginitis
- Status last verified
- Jun 2013
- First submitted
- 16 Aug 2011
- Last updated
- 21 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Saginil in Vaginal Cannulas vs. Placebo for the Prevention of Vaginitis in Gynecologic Oncologic Patients Receiving Chemotherapy: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01420510
- Acronym / sponsor ID
- Saginil in vaginitis
- Conditions
- Vaginitis
- Keywords
- Patients satisfaction, Side effects
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Università degli Studi dell'InsubriaUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 19 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adelmidrol | Experimental | Drug: Adelmidrol vaginal gelEfficacy of Adelmidrol vaginal gel in preventing vaginitis in oncologic patients |
| Placebo | Placebo comparator | Drug: Placebo vaginal gelEfficacy of Placebo in preventing vaginitis in oncologic patients |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Gynecologic malignancy
- Current administration of chemotherapy
Key exclusion criteria (4 listed)
- Colpectomy
- Vaginal cancer
- Vulvar cancer
- Bacterial vaginitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adelmidrol vaginal gelApplication of a Adelmidrol vaginal gel | Drug | Adelmidrol |
| Placebo vaginal gelApplication of a placebo vaginal gel | Drug | Placebo |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Adelmidrol vaginal gel in people with Vaginitis, run by Università degli Studi dell'Insubria at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabio Ghezzi, MD (+390332299309, fabio.ghezzi@uninsubria.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2013.