Trial · NCT01577238
A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis
NCT01577238, Phase 3, Completed, Starpharma Pty Ltd; results first posted 2019-07-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis. Trials, record NCT01577238. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01577238
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis
- NCT number
- NCT01577238
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 250 participants, actual
- Lead sponsor
- Starpharma Pty Ltd
- Conditions
- Bacterial Vaginosis
- Interventions
- 1% SPL7013 Gel, Placebo
- First posted
- 2012-04-13
- Last updated
- 2019-07-17
- Results first posted
- 2019-07-09
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Women With Clinical Cure at the End of Treatment Visit (EOT) | Day 9-12 | Clinical Cure is defined as the resolution of clinical findings (ie Amsel criteria) from the Baseline visit (Day 1) |
| Secondary | Number of Women With Nugent Cure at the EOT Visit | Day 9-12 | Nugent Cure is defined as a Nugent score of 0-3 (normal) |
| Secondary | Number of Women With Clinical Cure at the Test of Cure Visit (TOC) | Day 21-30 | Clinical Cure is defined as the resolution of clinical findings (ie Amsel criteria) from the Baseline visit (Day 1) |
| Secondary | Number of Women With Nugent Cure at the TOC Visit | Day 21-30 | Nugent Cure is defined as a Nugent score of 0-3 (normal) |
| Secondary | Adverse Events Potentially Related to Treatment | Screening/baseline through TOC visit, Day 1-30 | Number of participants with adverse events considered potentially related to study treatment |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Women With Clinical Cure at the End of Treatment Visit (EOT) | Day 9-12 | mITT | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Women With Nugent Cure at the EOT Visit | Day 9-12 | mITT | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Women With Clinical Cure at the Test of Cure Visit (TOC) | Day 21-30 | mITT | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Women With Nugent Cure at the TOC Visit | Day 21-30 | mITT | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Adverse Events Potentially Related to Treatment | Screening/baseline through TOC visit, Day 1-30 | Safety population. One participant of those randomized to the 1% SPL7013 Gel was lost to follow-up, and two participants of those randomized to Placebo did not use study medication, and therefore were not included in the Safety population. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Women With Clinical Cure at the End of Treatment Visit (EOT) | VivaGel | 59 | Participants | ||
| Number of Women With Clinical Cure at the End of Treatment Visit (EOT) | HEC Placebo | 19 | Participants | ||
| Number of Women With Nugent Cure at the EOT Visit | VivaGel | 15 | Participants | ||
| Number of Women With Nugent Cure at the EOT Visit | HEC Placebo | 3 | Participants | ||
| Number of Women With Clinical Cure at the Test of Cure Visit (TOC) | VivaGel | 31 | Participants | ||
| Number of Women With Clinical Cure at the Test of Cure Visit (TOC) | HEC Placebo | 24 | Participants | ||
| Number of Women With Nugent Cure at the TOC Visit | VivaGel | 11 | Participants | ||
| Number of Women With Nugent Cure at the TOC Visit | HEC Placebo | 5 | Participants | ||
| Adverse Events Potentially Related to Treatment | VivaGel | 20 | Participants | ||
| Adverse Events Potentially Related to Treatment | HEC Placebo | 14 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | VivaGel | 127 | |
| Overall Study | STARTED | HEC Placebo | 123 | |
| Overall Study | COMPLETED | VivaGel | 117 | |
| Overall Study | COMPLETED | HEC Placebo | 111 | |
| Overall Study | NOT COMPLETED | VivaGel | 10 | |
| Overall Study | NOT COMPLETED | HEC Placebo | 12 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Pneumonia | Infections and infestations | VivaGel | 1 | 126 | |
| serious | Pneumonia | Infections and infestations | HEC Placebo | 0 | 121 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | VivaGel | ||
| Total, all-cause mortality | HEC Placebo | ||
| Total, other adverse events | VivaGel | 0 | 126 |
| Total, other adverse events | HEC Placebo | 0 | 121 |
| Total, serious adverse events | VivaGel | 1 | 126 |
| Total, serious adverse events | HEC Placebo | 0 | 121 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| VivaGel vs HEC Placebo: Adverse Events Potentially Related to Treatment | Trial comparisons |
| VivaGel vs HEC Placebo: Number of Women With Nugent Cure at the TOC Visit | Trial comparisons |
| VivaGel vs HEC Placebo: Number of Women With Nugent Cure at the EOT Visit | Trial comparisons |
| VivaGel vs HEC Placebo: Number of Women With Clinical Cure at the Test of Cure Visit (TOC) | Trial comparisons |
| VivaGel vs HEC Placebo: Number of Women With Clinical Cure at the End of Treatment Visit (EOT) | Trial comparisons |
| VivaGel vs HEC Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01577238
GET https://conductscience.org/api/trials/v1/NCT01577238/registered