Bacterial VaginosisPhase 3NCT02237950

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 45 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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 16 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: 586 participants
Where: 45 sitesin 3 countries
Study dates: 13 Oct 2014to 22 Feb 2017
Phase: Phase 3
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 16 to 45 years
Women only
No healthy volunteers
Child, Adult

Who may be able to join

Current active episode of BV (diagnosis defined as: At least 3 of the 4 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

45 sites in 3 countries.

Country

City, postcode or hospital

45 sites in 3 countries

United States37 sites

Radiant Research
Akron, Ohio, 44311
Atlanta Medical Research Institute
Alpharetta, Georgia, 30041
Clinical Research Advantage
Anderson, South Carolina, 29621
University of Alabama
Birmingham, Alabama, 35233
PMG Research of Cary, LLC
Cary, North Carolina, 27518
Medical University of South Carolina
Charleston, South Carolina, 49425
Chattanooga Medical Research
Chattanooga, Tennessee, 37404
Lynn Institute of the Rockies
Colorado Springs, Colorado, 80907
Radiant Research
Columbus, Ohio, 43212
Practice Research Organization
Dallas, Texas, 75230
Downtown Women's Health Care
Denver, Colorado, 80209
The Community Research South Florida
Hialeah, Florida, 33016
Volunteer Research Group
Knoxville, Tennessee, 37920
Affiliated Clinical Research
Las Vegas, Nevada, 89105
Lawrence OB-GYN Associates
Lawrenceville, New Jersey, 08648
Women's Clinic of Lincoln, PC
Lincoln, Nebraska, 68510
Lynn Institute of the Ozarks
Little Rock, Arkansas, 72205
Urban Family Practice Associates
Marietta, Georgia, 30067
Women's Physician Group
Memphis, Tennessee, 38104
Florida Medical Center and Research Inc.
Miami, Florida, 33142
Research Institute of South Florida
Miami, Florida, 33173
Community Medical Research
Miami Beach, Florida, 33141
Montgomery Women's Health Associates
Montgomery, Alabama, 36117
Heartland Research Associates, LLC
Newton, Kansas, 67114
Lynn Institute of Norman
Norman, Oklahoma, 73069
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
Alegent Creighton Health
Omaha, Nebraska, 68154
Women's Healthcare Specialists
Paw Paw, Michigan, 49079
Clinical Research of Philadelphia
Philadelphia, Pennsylvania, 19114
Clinical Trials of Virginia
Richmond, Virginia, 23225
PMG Research of Salisbury
Salisbury, North Carolina, 28144
Radiant Research
San Antonio, Texas, 78229
Precision Research Institute
San Diego, California, 92114
Women's Health Care
San Diego, California, 92123
Women's Clinical Research Center
Seattle, Washington, 98105
Jordan River Family Medicine
South Jordan, Utah, 84088
Comprehensive Clinical Trials
West Palm Beach, Florida, 33409

Other trials in United States

Canada5 sites

Medicine Professional Corporation
Kitchener, Ontario, N2G1H6
DIEX Recherche Montreal Inc
Montreal, Quebec, H4N3C5
SKDS Research Inc
Newmarket, Ontario, L3Y5G8
DIEX Recherche Sherbrooke Inc.
Sherbrooke, Quebec, J1H1Z1
Healthy Image Centre
Windsor, Ontario, N955C6

Other trials in Canada

Puerto Rico3 sites

Torre Auxillo Mutuo
Hato Rey, 00917
Latin Clinical Trial Center
San Juan, 00918
University of Puerto Rico
San Juan

Other trials in Puerto Rico

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

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 groups in NCT02237950
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 of BV, where a diagnosis of BV is defined as the presence of at least 3 clinical findings (Amsel criteria)
Measured: At or by the Week 16 visit

Secondary outcomes (8)

Time to Recurrence of BV Where a Diagnosis of BV is Defined as the Presence of at Least 3 Clinical Findings
Time to recurrence of BV (days), where a diagnosis of BV is defined as the presence of at least 3 clinical findings (Amsel criteria)
Measured: At or by the Week 16 visit
Recurrence of Patient-reported BV Symptoms
Number of participants with self-reported BV symptoms (vaginal discharge and/or odor)
Measured: At or by the Week 16 visit
Recurrence of Individual Amsel Criteria
Number of participants with positive individual Amsel criterion
- Clue cells representing at least 20% of total epithelial cells
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 of BV as determined by presence of a Nugent score of 7-10 (BV), where 0-3 is normal, and 4-6 is intermediate.
Measured: At or by the Week 16 visit
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 of BV, where a diagnosis of BV is defined as the presence of at least 3 clinical findings (Amsel criteria)
Measured: At or by the Week 24 visit
Recurrence of BV According to the Composite Definition of at Least 3 Clinical Findings (Amsel Criteria) and a Nugent Score of 4-10.
Number of participants with a recurrence of BV according to the composite definition of at least 3 clinical findings (Amsel criteria) and a Nugent score of 4-10 (intermediate to BV), where 0-3 is normal.
Measured: At or by the Week 16 visit
Change From Baseline in Brief Index of Sexual Functioning for Women Questionnaire Composite Score
Change from baseline in brief index of sexual functioning for women (BISF-W) questionnaire composite score. The composite score includes scores from dimensions (D) of thoughts/desire (D1, 0-12), arousal (D2, 0-12), frequency of sexual activity (D3, 0-12), receptivity/initiation (D4, 0-12), pleasure (D5, 0-12), relationship satisfaction (D6, 0-12), and any problems affecting sexual functioning (D7, 0-16). The composite score is calculated as D1+D2+D3+D4+D5+D6-D7 with a range of -16 to +75. A positive change in composite score from baseline to Week 16 reflects an improvement in sexual functioning, with a greater change in score indicating a greater improvement in sexual functioning.
Measured: Baseline to Week 16
Adverse Events (AEs)
Number of participants with genitourinary AEs considered potentially related to study treatment
Measured: From Baseline to end of Week 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Oct 201422 Feb 2017

First posted12 Sep 2014 (estimated)
Study start13 Oct 2014
Primary completion9 Dec 2016
Study completion22 Feb 2017

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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 586 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02237950
Sponsor's protocol ID: SPL7013-017
Status last verified: Jul 2019
First submitted: 5 Sep 2014
Last updated: 22 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Bacterial Vaginosis trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jul 2019. 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: NCT02237950
Acronym / sponsor ID: SPL7013-017
Conditions: Bacterial Vaginosis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 586 participants (actual)
Lead sponsor: Starpharma Pty LtdIndustry (pharma, biotech, devices)
Study start: 13 Oct 2014 (actual)
Primary completion: 9 Dec 2016 (actual)
Study completion: 22 Feb 2017 (actual)
First posted: 12 Sep 2014 (estimated)
Results: Posted 9 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The primary endpoint will be determined at the conclusion of this 16 week treatment phase.

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: 16 to 45 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

Current active episode of BV (diagnosis defined as: At least 3 of the 4 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 of BV, where a diagnosis of BV is defined as the presence of at least 3 clinical findings (Amsel criteria)

8 secondary outcomes

Time to 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
Recurrence 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 Where a Diagnosis of BV is Defined as the Presence of at Least 3 Clinical Findings
Time frame: At or by the Week 24 visit
Recurrence of BV According to the Composite Definition of at Least 3 Clinical Findings (Amsel Criteria) and a Nugent Score of 4-10.
Time frame: At or by the Week 16 visit
Change From Baseline in Brief Index of Sexual Functioning for Women Questionnaire Composite Score
Time frame: Baseline to Week 16
Adverse Events (AEs)
Time frame: From Baseline to end of Week 28

Results and safety

Results posted to the registry on 9 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1% SPL7013 Gel	295	247
Placebo Gel	291	243

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. Count of participants. Unit: Participants

Measure	1% SPL7013 Gel n = 294	Placebo Gel n = 291
Value	130	158

1% SPL7013 Gel vs Placebo Gel: p = 0.015, Regression, Logistic

Population analysed: Analysis population is the modified intent-to-treat analysis population. One patient was excluded compared with the intent-to-treat population because they were dispensed medication but returned all unused.

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1% SPL7013 Gel	4 of 294 (1.4%)	92 of 294 (31.3%)	Not reported
Placebo Gel	3 of 291 (1%)	80 of 291 (27.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 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.

Jeremy Paull, PhD. study chair

Starpharma Pty Ltd

45 sites in 3 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 45 sites in 3 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 22 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in United States, Canada, Puerto Rico. 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?

Yes. Results are posted in the registry (first posted 9 Jul 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?

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?

On the ClinicalTrials.gov record for NCT02237950.

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 22 Jul 2019.