Bacterial VaginosisPhase 3NCT02236156
Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV)
A Phase 3 study testing Metronidazole oral tablets 500mg and 1% SPL7013 Gel in people with Bacterial Vaginosis, run by Starpharma Pty Ltd at 30 sites in 6 countries.
Trial summary
A double-blind, phase 3 study to determine the efficacy of SPL7013 Gel when administered on alternate days for 16 weeks, compared to placebo gel in preventing the recurrence of BV in women with a history of recurrent BV. 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?
- Metronidazole oral tablets 500mg and 1% SPL7013 Gel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 637 participants
- Where
- 30 sitesin 6 countries
- Study dates
- 3 Oct 2014to 4 Oct 2016
- Phase
- Phase 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Current active episode of BV (diagnosis defined as: at least 3 Amsel criteria; Nugent score of at least 4; presence of BV-related symptoms)
- History of recurrent BV (at least 3 episodes in previous year including current episode)
- Using an effective method of contraception
Who cannot join
- Test positive for a sexually transmitted infection
- Presence of genital Herpes Simplex Virus (HSV) lesions or Human Papilloma Virus (HPV) lesions requiring treatment
- Abnormal pelvic exam, including presence of other vaginal or urinary tract infections
- Pregnancy
Trial locations and contacts
30 sites in 6 countries.
30 sites in 6 countries
Hungary8 sites
Sites Various
Baja
Sites Various
Balatonfüred
Sites Various
Budapest
Sites Various
Debrecen
Sites Various
Gyömrő
Sites Various
Komárom
Sites Various
Létavértes
Sites Various
Zalaegerszeg
Czechia6 sites
Sites Various
Brno
Sites Various
České Budějovice
Sites Various
Olomouc
Sites Various
Písek
Sites Various
Prague
Sites Various
Vsetín
United Kingdom5 sites
Sites Various
Birmingham
Sites Various
Coventry
Sites Various
Leeds
Sites Various
London
Sites Various
Plymouth
United States4 sites
Southern Clinical Research Associates
Metairie, Louisiana, 70001
Precision Trials, LLC
Phoenix, Arizona, 85032
Medical Center for Clinical Research
San Diego, California, 92108
Lyndhurst Clinical Research
Winston-Salem, North Carolina, 27103
Bulgaria4 sites
Sites Various
Pleven
Sites Various
Plovidiv
Sites Various
Sofia
Sites Various
Stara Zagora
Ukraine3 sites
Sites Various
Ivano-Frankivsk
Sites Various
Kyiv
Sites Various
Zaporizhzhya
About this study
Official title: A Phase 3, Double-blind, Multicentre, Randomised, Placebo-controlled Study to Determine the Efficacy and Safety of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis.
A double-blind, phase 3 study to determine the efficacy of SPL7013 Gel when administered on alternate days for 16 weeks, compared to placebo gel in preventing the recurrence of BV in women with a history of recurrent BV.
Read the detailed description
Eligible participants, with both a history of recurrent BV and a current episode of BV, will receive a seven-day course of oral metronidazole. Participants who are successfully treated for their BV, and continue to be eligible, will be randomly assigned to receive either 1% SPL7013 Gel or placebo gel on alternate days at bed-time for 16 consecutive weeks.
The primary endpoint will be determined at the conclusion of this 16 week treatment phase.
Participants who experience a BV recurrence will be considered to have completed the study. Such participants will receive BV treatment in line with local practice and will not attend any further study visits.
Participants who successfully reach Week 16 without a BV recurrence will enter a 12-week follow-up phase to Week 28.
Participants will attend a study visit at 4-weekly intervals throughout the duration of the study to Week 28 (or up to the point of BV recurrence) to assess recurrence of BV and adverse events.
- Conditions
- Bacterial Vaginosis
- Being tested
- Metronidazole oral tablets 500mg, 1% SPL7013 Gel, Placebo gel
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metronidazole oral tablets 500mgDrug
One tablet taken orally twice daily for seven consecutive days
1% SPL7013 GelDrug
Also called VivaGel, astodimer sodium
5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.
Placebo gelDrug
5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks
| Study group | Role | What they receive |
|---|---|---|
| 1% SPL7013 Gel | Experimental | Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks Receives: Drug: Metronidazole oral tablets 500mg; Drug: 1% SPL7013 Gel |
| Placebo Gel | Placebo comparator | Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks Receives: Drug: Metronidazole oral tablets 500mg; Drug: Placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of BV where a diagnosis of BV is defined as the presence of at least 3 clinical findings
Number of participants with a recurrence
Measured: At or by the Week 16 visit
Secondary outcomes (8)
Time to recurrence of BV according to the primary efficacy endpoint definition
Time (days)
Measured: At or by the Week 28 visit
Presence of patient-reported BV symptoms
Number of participants with symptoms
Measured: At or by the Week 16 visit
Recurrence of individual Amsel criteria
Individual Amsel criteria are:
- Presence of homogenous vaginal discharge characteristic of BV ii) Positive whiff test iii) Clue cells representing at least 20% of total epithelial cells iv) vaginal fluid pH greater than 4.5
Measured: At or by the Week 16 visit
Recurrence of BV as determined by presence of a Nugent score of 7-10
Number of participants with a recurrence
Measured: At or by the Week 16 visit
Recurrence of BV according to the primary efficacy endpoint definition
Number of participants with a recurrence
Measured: At or by the Week 20, 24 and 28 visits
Recurrence of BV according to the composite definition of at least 3 clinical findings and a Nugent score of at least 4
Number of participants with a recurrence
Measured: At or by the Week 16 visit
Adverse events (AEs)
Number of participants
Measured: Study duration
Responses to Quality of Life (QoL) Questionnaires
Measured: Screening to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study start3 Oct 2014
- Primary completion4 Jul 2016
- Study completion4 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 637 participants (actual)
Sponsor and investigators
- Lead sponsor
- Starpharma Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeremy Paull, PhD., Study chair, Starpharma Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02236156
- Sponsor's protocol ID
- SPL7013-018
- Status last verified
- Jun 2018
- First submitted
- 5 Sep 2014
- Last updated
- 25 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Double-blind, Multicentre, Randomised, Placebo-controlled Study to Determine the Efficacy and Safety of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis.
- ClinicalTrials.gov ID
- NCT02236156
- Acronym / sponsor ID
- SPL7013-018
- Conditions
- Bacterial Vaginosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 637 participants (actual)
- Lead sponsor
- Starpharma Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 3 Oct 2014 (actual)
- Primary completion
- 4 Jul 2016 (actual)
- Study completion
- 4 Oct 2016 (actual)
- First posted
- 10 Sep 2014 (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.
A double-blind, phase 3 study to determine the efficacy of SPL7013 Gel when administered on alternate days for 16 weeks, compared to placebo gel in preventing the recurrence of BV in women with a history of recurrent BV.
Detailed description
Eligible participants, with both a history of recurrent BV and a current episode of BV, will receive a seven-day course of oral metronidazole. Participants who are successfully treated for their BV, and continue to be eligible, will be randomly assigned to receive either 1% SPL7013 Gel or placebo gel on alternate days at bed-time for 16 consecutive weeks.
The primary endpoint will be determined at the conclusion of this 16 week treatment phase.
Participants who experience a BV recurrence will be considered to have completed the study. Such participants will receive BV treatment in line with local practice and will not attend any further study visits.
Participants who successfully reach Week 16 without a BV recurrence will enter a 12-week follow-up phase to Week 28.
Participants will attend a study visit at 4-weekly intervals throughout the duration of the study to Week 28 (or up to the point of BV recurrence) to assess recurrence of BV and adverse events.
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 |
|---|---|---|
| 1% SPL7013 Gel | Experimental | Drug: Metronidazole oral tablets 500mg, Drug: 1% SPL7013 GelInserted in to the vagina on alternate days (i.e. every other day) for 16 weeks |
| Placebo Gel | Placebo comparator | Drug: Metronidazole oral tablets 500mg, Drug: Placebo gelInserted in to the vagina on alternate days (i.e. every other day) for 16 weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Current active episode of BV (diagnosis defined as: at least 3 Amsel criteria; Nugent score of at least 4; presence of BV-related symptoms)
- History of recurrent BV (at least 3 episodes in previous year including current episode)
- Using an effective method of contraception
Key exclusion criteria (4 listed)
- Test positive for a sexually transmitted infection
- Presence of genital Herpes Simplex Virus (HSV) lesions or Human Papilloma Virus (HPV) lesions requiring treatment
- Abnormal pelvic exam, including presence of other vaginal or urinary tract infections
- Pregnancy
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 |
|---|---|---|
| Metronidazole oral tablets 500mgOne tablet taken orally twice daily for seven consecutive days | Drug | 1% SPL7013 Gel, Placebo Gel |
| 1% SPL7013 GelAlso: VivaGel, astodimer sodium5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks. | Drug | 1% SPL7013 Gel |
| Placebo gel5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks | Drug | Placebo Gel |
Primary outcome
Recurrence of BV where a diagnosis of BV is defined as the presence of at least 3 clinical findings
Time frame: At or by the Week 16 visit
Number of participants with a recurrence
8 secondary outcomes
Time to recurrence of BV according to the primary efficacy endpoint definition
Time frame: At or by the Week 28 visit
Presence of patient-reported BV symptoms
Time frame: At or by the Week 16 visit
Recurrence of individual Amsel criteria
Time frame: At or by the Week 16 visit
Recurrence of BV as determined by presence of a Nugent score of 7-10
Time frame: At or by the Week 16 visit
Recurrence of BV according to the primary efficacy endpoint definition
Time frame: At or by the Week 20, 24 and 28 visits
Recurrence of BV according to the composite definition of at least 3 clinical findings and a Nugent score of at least 4
Time frame: At or by the Week 16 visit
Adverse events (AEs)
Time frame: Study duration
Responses to Quality of Life (QoL) Questionnaires
Time frame: Screening to Week 16
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 25 Jun 2018.
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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 chair
Starpharma Pty Ltd
30 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Metronidazole oral tablets 500mg and 1% SPL7013 Gel in people with Bacterial Vaginosis, run by Starpharma Pty Ltd at 30 sites in 6 countries.
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 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: finished, as of the sponsor's last update on 25 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Hungary, Czechia, United Kingdom, United States, Bulgaria and 1 more country. 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 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?
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?
Recurrence of BV where a diagnosis of BV is defined as the presence of at least 3 clinical findings (time frame: At or by the Week 16 visit). 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 25 Jun 2018.