Bacterial VaginosisPhase 2NCT01201057
Dose Ranging Study of SPL7013 Gel for Treatment of Bacterial Vaginosis (BV)
A Phase 2 study testing 0.5% SPL7013 Gel, 1.0% SPL7013 Gel and 3.0% SPL7013 Gel in people with Bacterial Vaginosis, run by Starpharma Pty Ltd at 5 sites in United States.
Trial summary
The purpose of this study is to determine the efficacy of SPL7013 Gel in the treatment of bacterial vaginosis. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- 0.5% SPL7013 Gel, 1.0% SPL7013 Gel and 3.0% SPL7013 Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 5 sitesUnited States
- Study dates
- Aug 2010to May 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 diagnosis of BV according to Amsel's criteria and a Nugent score of ≥4
- Otherwise healthy
Who cannot join
- No active STIs
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Downtown Women's Health Care
Denver, Colorado, 80218
Bexar Clinical Trials, LLC
Irving, Texas, 75061
Clinical Research Center of Nevada
Las Vegas, Nevada, 89104
Precision Trials
Phoenix, Arizona, 85032
Tidewater Clinical Research Inc
Virginia Beach, Virginia, 23456
About this study
Official title: A Double-blind, Multi-center, Randomized, Placebo Controlled, Dose-ranging Study to Determine the Efficacy and Safety of SPL7013 Gel (VivaGel®) Administered Vaginally in the Treatment of Bacterial Vaginosis
The purpose of this study is to determine the efficacy of SPL7013 Gel in the treatment of bacterial vaginosis.
- Conditions
- Bacterial Vaginosis
- Being tested
- 0.5% SPL7013 Gel, 1.0% SPL7013 Gel, 3.0% SPL7013 Gel, Placebo Gel
- Keywords
- SPL7013, VivaGel, bacterial vaginosis, BV
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5% SPL7013 GelDrug
Vaginal gel
1.0% SPL7013 GelDrug
Vaginal gel
3.0% SPL7013 GelDrug
Vaginal gel
Placebo GelOther
Vaginal gel
| Study group | Role | What they receive |
|---|---|---|
| 0.5% SPL7013 Gel | Experimental | Not described Receives: Drug: 0.5% SPL7013 Gel |
| 1.0% SPL7013 Gel | Experimental | Not described Receives: Drug: 1.0% SPL7013 Gel |
| 3.0% SPL7013 Gel | Experimental | Not described Receives: Drug: 3.0% SPL7013 Gel |
| Placebo Gel | Placebo comparator | Not described Receives: Other: Placebo Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Women With Clinical Cure as a Measure of Efficacy
Number of women with clinical cure as determined by absence of BV by the Amsel's criteria
Measured: Day 21-30
Secondary outcomes (4)
Number of Women With Clinical Cure as a Measure of Efficacy
Number of women with clinical cure as determined by absence of BV by the Amsel's criteria
Measured: Day 9-12
Number of Women With Nugent Cure as a Measure of Efficacy
Number of women with Nugent cure, defined as a Nugent score 0-3 (normal flora), when a score of 7-10 (BV flora) was determined at Baseline.
Measured: Day 9-30
Patient Perceived Symptom Resolution as a Measure of Efficacy (Odor)
Number of women with absence of patient-reported vaginal odor, as determined by responses in a symptom questionnaire as to whether or not they had vaginal odor.
Measured: Day 9-30
Incidence of Genital Adverse Events Potentially Related to Treatment
Number of women who experience signs/symptoms of genital irritation potentially related to treatment, by solicited reporting of specific AEs as a measure of safety.
Measured: For the duration of the study (up to Visit Day 21-30)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionMar 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bacterial VaginosisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Starpharma Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anne Macek, MD, Principal investigator, contracted to Starpharma Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01201057
- Sponsor's protocol ID
- SPL7013-013
- Status last verified
- Jun 2019
- First submitted
- 30 Aug 2010
- Last updated
- 6 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Multi-center, Randomized, Placebo Controlled, Dose-ranging Study to Determine the Efficacy and Safety of SPL7013 Gel (VivaGel®) Administered Vaginally in the Treatment of Bacterial Vaginosis
- ClinicalTrials.gov ID
- NCT01201057
- Acronym / sponsor ID
- SPL7013-013
- Conditions
- Bacterial Vaginosis
- Keywords
- SPL7013, VivaGel, bacterial vaginosis, BV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Starpharma Pty LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 14 Sep 2010 (estimated)
- Results
- Posted 6 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the efficacy of SPL7013 Gel in the treatment of bacterial vaginosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0.5% SPL7013 Gel | Experimental | Drug: 0.5% SPL7013 Gel |
| 1.0% SPL7013 Gel | Experimental | Drug: 1.0% SPL7013 Gel |
| 3.0% SPL7013 Gel | Experimental | Drug: 3.0% SPL7013 Gel |
| Placebo Gel | Placebo comparator | Other: Placebo Gel |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women aged 18-45 years with a diagnosis of BV according to Amsel's criteria and a Nugent score of ≥4
- Otherwise healthy
Key exclusion criteria (1 listed)
- No active STIs
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 |
|---|---|---|
| 0.5% SPL7013 GelVaginal gel | Drug | 0.5% SPL7013 Gel |
| 1.0% SPL7013 GelVaginal gel | Drug | 1.0% SPL7013 Gel |
| 3.0% SPL7013 GelVaginal gel | Drug | 3.0% SPL7013 Gel |
| Placebo GelVaginal gel | Other | Placebo Gel |
Primary outcome
Number of Women With Clinical Cure as a Measure of Efficacy
Time frame: Day 21-30
Number of women with clinical cure as determined by absence of BV by the Amsel's criteria
4 secondary outcomes
Number of Women With Clinical Cure as a Measure of Efficacy
Time frame: Day 9-12
Number of Women With Nugent Cure as a Measure of Efficacy
Time frame: Day 9-30
Patient Perceived Symptom Resolution as a Measure of Efficacy (Odor)
Time frame: Day 9-30
Incidence of Genital Adverse Events Potentially Related to Treatment
Time frame: For the duration of the study (up to Visit Day 21-30)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Bacterial Vaginosis
Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
Not yet recruitingPhase 2
WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
Bacterial Vaginosis (BV)
RecruitingPhase 1
A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
Randomized, Open-label
Not yet recruitingPhase 1
A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
Bacterial Vaginosis
Recruiting
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Bacterial Vaginoses
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.
Anne Macek, MD principal investigator
contracted to Starpharma Pty Ltd
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 0.5% SPL7013 Gel, 1.0% SPL7013 Gel and 3.0% SPL7013 Gel in people with Bacterial Vaginosis, run by Starpharma Pty Ltd at 5 sites in United States.
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 1 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 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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 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?
Yes. Results are posted in the registry (first posted 6 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 With Clinical Cure as a Measure of Efficacy (time frame: Day 21-30). 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 6 Jun 2019.