Recurrent Bacterial Vaginosis (BV)Phase 2NCT01437722
Dose-ranging Study of SPL7013 Gel for the Prevention of Bacterial Vaginosis (BV)
A Phase 2 study testing 1% SPL7013 Gel and 3% SPL7013 Gel in people with Recurrent Bacterial Vaginosis (BV), run by Starpharma Pty Ltd.
Trial summary
The purpose in this clinical study is to determine the efficacy of SPL7013 Gel for the prevention of recurrence of bacterial vaginosis. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Recurrent Bacterial Vaginosis (BV)
- What is being tested?
- 1% SPL7013 Gel and 3% SPL7013 Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 205 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to Dec 2012
- Phase
- Phase 2
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18-45 years with a history of recurrent BV, defined as at least 3 documented episodes in the previous 12 months (including the current episode).
- Current episode of BV as defined by subject-reported symptoms and Amsel's Criteria
- Otherwise healthy
Who cannot join
- No active STIs and/or current UTI
- Previous exposure to SPL7013 Gel
- A Papanicolaou (Pap) smear result considered to be clinically significant (ie, high grade cervical intraepithelial squamous lesions [HSIL] on cytology or cervical intraepithelial neoplasia [CIN] grades of CIN2 or CIN3 on histology) in the previous 2 years or in accordance with local treatment guidelines.
About this study
Official title: A Double-blind, Multicenter, Randomized, Placebo-controlled, Dose-ranging Study to Determine the Efficacy and Safety of SPL7013 Gel (VivaGel®) Administered Vaginally to Prevent the Recurrence of Bacterial Vaginosis
The purpose in this clinical study is to determine the efficacy of SPL7013 Gel for the prevention of recurrence of bacterial vaginosis.
- Conditions
- Recurrent Bacterial Vaginosis (BV)
- Being tested
- 1% SPL7013 Gel, 3% SPL7013 Gel, placebo gel
- Keywords
- BV, Bacterial vaginosis, recurrent, SPL7013 Gel, VivaGel
- Medical subject headings
- Vaginosis, Bacterial, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% SPL7013 GelDrug
vaginal gel
3% SPL7013 GelDrug
vaginal gel
placebo gelDrug
vaginal gel
| Study group | Role | What they receive |
|---|---|---|
| 1% SPL7013 Gel | Experimental | Not described Receives: Drug: 1% SPL7013 Gel |
| 3% SPL7013 Gel | Experimental | Not described Receives: Drug: 3% SPL7013 Gel |
| placebo gel | Placebo comparator | Not described Receives: Drug: placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of women who have experienced a recurrent episode of BV as a measure of efficacy
Number of women who have BV as measured by subject-reported symptoms and Amsel's Criteria
Measured: Day 112 +/- 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Bacterial Vaginosis (BV)Studies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Starpharma Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeremy Paull, PhD, Study director, Starpharma Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01437722
- Sponsor's protocol ID
- SPL7013-014
- Status last verified
- Oct 2013
- First submitted
- 20 Sep 2011
- Last updated
- 20 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Multicenter, Randomized, Placebo-controlled, Dose-ranging Study to Determine the Efficacy and Safety of SPL7013 Gel (VivaGel®) Administered Vaginally to Prevent the Recurrence of Bacterial Vaginosis
- ClinicalTrials.gov ID
- NCT01437722
- Acronym / sponsor ID
- SPL7013-014
- Conditions
- Recurrent Bacterial Vaginosis (BV)
- Keywords
- BV, Bacterial vaginosis, recurrent, SPL7013 Gel, VivaGel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Starpharma Pty LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Dec 2012 (actual)
- First posted
- 21 Sep 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.
The purpose in this clinical study is to determine the efficacy of SPL7013 Gel for the prevention of recurrence of bacterial vaginosis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1% SPL7013 Gel | Experimental | Drug: 1% SPL7013 Gel |
| 3% SPL7013 Gel | Experimental | Drug: 3% SPL7013 Gel |
| placebo gel | Placebo comparator | Drug: placebo gel |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women aged 18-45 years with a history of recurrent BV, defined as at least 3 documented episodes in the previous 12 months (including the current episode).
- Current episode of BV as defined by subject-reported symptoms and Amsel's Criteria
- Otherwise healthy
Key exclusion criteria (3 listed)
- No active STIs and/or current UTI
- Previous exposure to SPL7013 Gel
- A Papanicolaou (Pap) smear result considered to be clinically significant (ie, high grade cervical intraepithelial squamous lesions [HSIL] on cytology or cervical intraepithelial neoplasia [CIN] grades of CIN2 or CIN3 on histology) in the previous 2 years or in accordance with local treatment guidelines.
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 |
|---|---|---|
| 1% SPL7013 Gelvaginal gel | Drug | 1% SPL7013 Gel |
| 3% SPL7013 Gelvaginal gel | Drug | 3% SPL7013 Gel |
| placebo gelvaginal gel | Drug | placebo gel |
Primary outcome
Number of women who have experienced a recurrent episode of BV as a measure of efficacy
Time frame: Day 112 +/- 5
Number of women who have BV as measured by subject-reported symptoms and Amsel's Criteria
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 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.
Jeremy Paull, PhD study director
Starpharma Pty Ltd
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 1% SPL7013 Gel and 3% SPL7013 Gel in people with Recurrent Bacterial Vaginosis (BV), run by Starpharma Pty Ltd.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 20 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of women who have experienced a recurrent episode of BV as a measure of efficacy (time frame: Day 112 +/- 5). 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 20 Nov 2013.