Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV)
NCT ID: NCT02236156
Last Updated: 2018-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
637 participants
INTERVENTIONAL
2014-10-03
2016-10-04
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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1% SPL7013 Gel
Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks
Metronidazole oral tablets 500mg
One tablet taken orally twice daily for seven consecutive days
1% SPL7013 Gel
5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.
Placebo Gel
Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks
Metronidazole oral tablets 500mg
One tablet taken orally twice daily for seven consecutive days
Placebo gel
5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks
Interventions
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Metronidazole oral tablets 500mg
One tablet taken orally twice daily for seven consecutive days
1% SPL7013 Gel
5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.
Placebo gel
5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* History of recurrent BV (at least 3 episodes in previous year including current episode)
* Using an effective method of contraception
Exclusion Criteria
* 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
18 Years
45 Years
FEMALE
No
Sponsors
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Starpharma Pty Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Jeremy Paull, PhD.
Role: STUDY_CHAIR
Starpharma Pty Ltd
Locations
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Precision Trials, LLC
Phoenix, Arizona, United States
Medical Center for Clinical Research
San Diego, California, United States
Southern Clinical Research Associates
Metairie, Louisiana, United States
Lyndhurst Clinical Research
Winston-Salem, North Carolina, United States
Sites Various
Pleven, , Bulgaria
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Plovidiv, , Bulgaria
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Sofia, , Bulgaria
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Stara Zagora, , Bulgaria
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Brno, , Czechia
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České Budějovice, , Czechia
Sites Various
Olomouc, , Czechia
Sites Various
Písek, , Czechia
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Prague, , Czechia
Sites Various
Vsetín, , Czechia
Sites Various
Baja, , Hungary
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Balatonfüred, , Hungary
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Budapest, , Hungary
Sites Various
Debrecen, , Hungary
Sites Various
Gyömrő, , Hungary
Sites Various
Komárom, , Hungary
Sites Various
Létavértes, , Hungary
Sites Various
Zalaegerszeg, , Hungary
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Ivano-Frankivsk, , Ukraine
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Kyiv, , Ukraine
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Zaporizhzhia, , Ukraine
Sites Various
Birmingham, , United Kingdom
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Coventry, , United Kingdom
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Leeds, , United Kingdom
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London, , United Kingdom
Sites Various
Plymouth, , United Kingdom
Countries
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Other Identifiers
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SPL7013-018
Identifier Type: -
Identifier Source: org_study_id
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